ACC 2011

NEW ORLEANS – Introduced to the U.S. market in 2008 as an upgraded alternative to the intra-arterial balloon pump, the Impella 2.5 showed clear signs of better performance in high-risk patients undergoing percutaneous coronary intervention in a multicenter, randomized trial with 447 patients.

But once Impella 2.5 entered the U.S. market, enrollment into the study slowed dramatically. Eventually, researchers stopped the trial substantially short of its enrollment target, and the pivotal study’s primary end point did not show a statistically significant benefit for Impella 2.5.

The trial also ran into a second problem with a major confounding issue: Interventional cardiologists used rotational atherectomy more aggressively in Impella-treated patients. They seemingly were emboldened by the added cardiac support, and Impella-treated patients had an unbalanced rate of adverse effects.

Despite these problems, the trial results showed a role for the Impella device in high-risk, low-cardiac-output patients undergoing PCI (percutaneous coronary intervention), Dr. William O’Neill said at the annual meeting of the American College of Cardiology.

"This device produces superb hemodynamic support during high-risk interventions. It really allows a more complete procedure that leads to fewer late events," said Dr. O’Neill, an interventional cardiologist and executive dean for clinical affairs at the University of Miami. "With these [high-risk] patients, we skate rapidly over thin ice. This device allows us the luxury of taking more time and doing a more complete and safer procedure. I think [that capability] will translate into increased use [of the device] in these high-risk patients."

Experts who heard the trial results were split on their interpretation of the findings.

"This was a negative study. What is driving the differences you see? I don’t understand how to reconcile the results with your conclusion to go ahead [with using] this device," commented Dr. Ron Waksman, director of experimental angioplasty at Washington (D.C.) Hospital Center.

PROTECT II was a prospective, multicenter, randomized, controlled trial of the Impella Recover LP 2.5 system vs. IABP (intra-aortic balloon pump) in patients undergoing nonemergent, high-risk PCI. The trial began in November 2007 at 67 U.S. sites, 4 sites in Canada, and 1 site in the Netherlands. It enrolled patients with either unprotected left main coronary disease and a left ventricular ejection fraction of 35% or less, or patients with triple-vessel coronary disease and an ejection fraction of 30% or less. The primary end point was the 30-day rate of death, MI, stroke, need for repeat revascularization, need for cardiovascular surgery or vascular surgery for limb ischemia, acute renal dysfunction, increased aortic insufficiency, severe hypotension, need for cardiopulmonary resuscitation, ventricular tachycardia, or failure to reopen the target coronaries by PCI.

The patients averaged 67 years old, 80% were men, and 56% had New York Heart Association class III or IV heart failure. Their average Society of Thoracic Surgeons (STS) mortality score was 6, their average SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 30, and 63% were considered ineligible for surgery. "The population was "extraordinarily high risk, the most complex patients ever enrolled in a multicenter, randomized, controlled trial, Dr. O’Neill said. There were 447 patients enrolled in PROTECT II before the study’s data and safety monitoring board stopped the trial last December. This number was 70% of the number of patients originally identified as needed to produce a statistically significant result for the primary end point. Enrollment into the study sharply slowed once the Impella device came onto the U.S. market in June 2008.

During PCI, the participating operators generally managed the Impella patients more aggressively. Heparin was given to 94% in the Impella arm and to 82% in the IABP control arm. Rotational atherectomy was performed in 15% of the Impella patients and in 10% of patients in the IABP arm, a statistically significant difference. Also, participating operators used atherectomy more aggressively in the Impella patients, with an average of five atherectomy passes per patient, compared with two passes in the IABP patients.

Although this shift in treatment approach may have ultimately benefited some of the Impella patients, it also "increased the major adverse event rate and confounded the analysis," Dr. O’Neill said. "About 70% of patients treated with atherectomy in the Impella group had an adverse event" – primarily rises in the level of creatine kinase–myoglobin – "compared with about 35% treated with atherectomy in the IABP group," he said in an interview. "It was a procedural imbalance that was hard to control for" in the safety and efficacy analysis.

There was no statistically significant difference for the study’s primary outcome, the combined major adverse event rate in the intention-to-treat analysis at 30 days after treatment, as well as at 90 days after treatment. However, at both time points, patients in the Impella arm showed trends toward lower major adverse events rates. At 30 days, the Impella patients had a 36% rate, compared with a 40% rate in the IABP patients. At 90 days, the rates reached 41% and 50%, respectively.

In the per-protocol analysis, at 30 days the Impella patients had a major adverse event rate of 35%, compared with 43% in the IABP patients, which was not a statistically significant difference. At 90 days, the rates reached 41% and 51% respectively, a difference that was statistically significant.

Dr. O’Neill addressed concerns that the major adverse event measure included many elements of sharply differing clinical importance. "What drove the difference [between the two study arms] was death, myocardial infarction, and need for urgent revascularization – not the small stuff. The real major adverse cardiac events were significantly better" when the Impella device was used, he said in an interview.

An analysis of several prespecified subgroups also highlighted certain types of patients who had significant benefit from the Impella device for the study’s primary end point. Among the 88% of patients in the study who were not treated with rotational atherectomy, the 30-day major adverse event rate reached 30%, compared with 42% in the IABP patients, a statistically significant difference. A significant difference in the primary outcome in favor of the Impella patients also occurred in the subgroup that had an STS mortality score lower than 10.

The results also showed a strong trend toward a better primary outcome in the Impella-treated patients when the analysis excluded the first Impella-treated patient for each operator, a finding that highlighted an important learning curve in using the device, Dr. O’Neill said.

Analysis also showed that the 90-day rate of major adverse events in the Impella patients fell from 48% in 2008 to 39% in 2009 and to 37% in 2010. In contrast, the rate in the IABP patients stayed fairly constant (at 47%-52%) in all 3 years, again highlighting the role of experience with the Impella device in achieving better patient outcomes, he said.

"I think many clinicians will see [from these data] that Impella provides a lot of safety," Dr. O’Neill said.

PROTECT II was sponsored by Abiomed, the company marketing the Impella 2.5 assist device. Dr. O’Neill said that he has been a consultant to Medtronic. Dr. Waksman said that he has been a consultant to or received honoraria from Medtronic Vascular, Abbott Vascular, Biotronik, Merck, and Boston Scientific.

NEW ORLEANS – Introduced to the U.S. market in 2008 as an upgraded alternative to the intra-arterial balloon pump, the Impella 2.5 showed clear signs of better performance in high-risk patients undergoing percutaneous coronary intervention in a multicenter, randomized trial with 447 patients.

But once Impella 2.5 entered the U.S. market, enrollment into the study slowed dramatically. Eventually, researchers stopped the trial substantially short of its enrollment target, and the pivotal study’s primary end point did not show a statistically significant benefit for Impella 2.5.

The trial also ran into a second problem with a major confounding issue: Interventional cardiologists used rotational atherectomy more aggressively in Impella-treated patients. They seemingly were emboldened by the added cardiac support, and Impella-treated patients had an unbalanced rate of adverse effects.

Despite these problems, the trial results showed a role for the Impella device in high-risk, low-cardiac-output patients undergoing PCI (percutaneous coronary intervention), Dr. William O’Neill said at the annual meeting of the American College of Cardiology.

"This device produces superb hemodynamic support during high-risk interventions. It really allows a more complete procedure that leads to fewer late events," said Dr. O’Neill, an interventional cardiologist and executive dean for clinical affairs at the University of Miami. "With these [high-risk] patients, we skate rapidly over thin ice. This device allows us the luxury of taking more time and doing a more complete and safer procedure. I think [that capability] will translate into increased use [of the device] in these high-risk patients."

Experts who heard the trial results were split on their interpretation of the findings.

"This was a negative study. What is driving the differences you see? I don’t understand how to reconcile the results with your conclusion to go ahead [with using] this device," commented Dr. Ron Waksman, director of experimental angioplasty at Washington (D.C.) Hospital Center.

PROTECT II was a prospective, multicenter, randomized, controlled trial of the Impella Recover LP 2.5 system vs. IABP (intra-aortic balloon pump) in patients undergoing nonemergent, high-risk PCI. The trial began in November 2007 at 67 U.S. sites, 4 sites in Canada, and 1 site in the Netherlands. It enrolled patients with either unprotected left main coronary disease and a left ventricular ejection fraction of 35% or less, or patients with triple-vessel coronary disease and an ejection fraction of 30% or less. The primary end point was the 30-day rate of death, MI, stroke, need for repeat revascularization, need for cardiovascular surgery or vascular surgery for limb ischemia, acute renal dysfunction, increased aortic insufficiency, severe hypotension, need for cardiopulmonary resuscitation, ventricular tachycardia, or failure to reopen the target coronaries by PCI.

The patients averaged 67 years old, 80% were men, and 56% had New York Heart Association class III or IV heart failure. Their average Society of Thoracic Surgeons (STS) mortality score was 6, their average SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 30, and 63% were considered ineligible for surgery. "The population was "extraordinarily high risk, the most complex patients ever enrolled in a multicenter, randomized, controlled trial, Dr. O’Neill said. There were 447 patients enrolled in PROTECT II before the study’s data and safety monitoring board stopped the trial last December. This number was 70% of the number of patients originally identified as needed to produce a statistically significant result for the primary end point. Enrollment into the study sharply slowed once the Impella device came onto the U.S. market in June 2008.

During PCI, the participating operators generally managed the Impella patients more aggressively. Heparin was given to 94% in the Impella arm and to 82% in the IABP control arm. Rotational atherectomy was performed in 15% of the Impella patients and in 10% of patients in the IABP arm, a statistically significant difference. Also, participating operators used atherectomy more aggressively in the Impella patients, with an average of five atherectomy passes per patient, compared with two passes in the IABP patients.

Although this shift in treatment approach may have ultimately benefited some of the Impella patients, it also "increased the major adverse event rate and confounded the analysis," Dr. O’Neill said. "About 70% of patients treated with atherectomy in the Impella group had an adverse event" – primarily rises in the level of creatine kinase–myoglobin – "compared with about 35% treated with atherectomy in the IABP group," he said in an interview. "It was a procedural imbalance that was hard to control for" in the safety and efficacy analysis.

There was no statistically significant difference for the study’s primary outcome, the combined major adverse event rate in the intention-to-treat analysis at 30 days after treatment, as well as at 90 days after treatment. However, at both time points, patients in the Impella arm showed trends toward lower major adverse events rates. At 30 days, the Impella patients had a 36% rate, compared with a 40% rate in the IABP patients. At 90 days, the rates reached 41% and 50%, respectively.

In the per-protocol analysis, at 30 days the Impella patients had a major adverse event rate of 35%, compared with 43% in the IABP patients, which was not a statistically significant difference. At 90 days, the rates reached 41% and 51% respectively, a difference that was statistically significant.

Dr. O’Neill addressed concerns that the major adverse event measure included many elements of sharply differing clinical importance. "What drove the difference [between the two study arms] was death, myocardial infarction, and need for urgent revascularization – not the small stuff. The real major adverse cardiac events were significantly better" when the Impella device was used, he said in an interview.

An analysis of several prespecified subgroups also highlighted certain types of patients who had significant benefit from the Impella device for the study’s primary end point. Among the 88% of patients in the study who were not treated with rotational atherectomy, the 30-day major adverse event rate reached 30%, compared with 42% in the IABP patients, a statistically significant difference. A significant difference in the primary outcome in favor of the Impella patients also occurred in the subgroup that had an STS mortality score lower than 10.

The results also showed a strong trend toward a better primary outcome in the Impella-treated patients when the analysis excluded the first Impella-treated patient for each operator, a finding that highlighted an important learning curve in using the device, Dr. O’Neill said.

Analysis also showed that the 90-day rate of major adverse events in the Impella patients fell from 48% in 2008 to 39% in 2009 and to 37% in 2010. In contrast, the rate in the IABP patients stayed fairly constant (at 47%-52%) in all 3 years, again highlighting the role of experience with the Impella device in achieving better patient outcomes, he said.

"I think many clinicians will see [from these data] that Impella provides a lot of safety," Dr. O’Neill said.

PROTECT II was sponsored by Abiomed, the company marketing the Impella 2.5 assist device. Dr. O’Neill said that he has been a consultant to Medtronic. Dr. Waksman said that he has been a consultant to or received honoraria from Medtronic Vascular, Abbott Vascular, Biotronik, Merck, and Boston Scientific.

NEW ORLEANS – Introduced to the U.S. market in 2008 as an upgraded alternative to the intra-arterial balloon pump, the Impella 2.5 showed clear signs of better performance in high-risk patients undergoing percutaneous coronary intervention in a multicenter, randomized trial with 447 patients.

But once Impella 2.5 entered the U.S. market, enrollment into the study slowed dramatically. Eventually, researchers stopped the trial substantially short of its enrollment target, and the pivotal study’s primary end point did not show a statistically significant benefit for Impella 2.5.

The trial also ran into a second problem with a major confounding issue: Interventional cardiologists used rotational atherectomy more aggressively in Impella-treated patients. They seemingly were emboldened by the added cardiac support, and Impella-treated patients had an unbalanced rate of adverse effects.

Despite these problems, the trial results showed a role for the Impella device in high-risk, low-cardiac-output patients undergoing PCI (percutaneous coronary intervention), Dr. William O’Neill said at the annual meeting of the American College of Cardiology.

"This device produces superb hemodynamic support during high-risk interventions. It really allows a more complete procedure that leads to fewer late events," said Dr. O’Neill, an interventional cardiologist and executive dean for clinical affairs at the University of Miami. "With these [high-risk] patients, we skate rapidly over thin ice. This device allows us the luxury of taking more time and doing a more complete and safer procedure. I think [that capability] will translate into increased use [of the device] in these high-risk patients."

Experts who heard the trial results were split on their interpretation of the findings.

"This was a negative study. What is driving the differences you see? I don’t understand how to reconcile the results with your conclusion to go ahead [with using] this device," commented Dr. Ron Waksman, director of experimental angioplasty at Washington (D.C.) Hospital Center.

PROTECT II was a prospective, multicenter, randomized, controlled trial of the Impella Recover LP 2.5 system vs. IABP (intra-aortic balloon pump) in patients undergoing nonemergent, high-risk PCI. The trial began in November 2007 at 67 U.S. sites, 4 sites in Canada, and 1 site in the Netherlands. It enrolled patients with either unprotected left main coronary disease and a left ventricular ejection fraction of 35% or less, or patients with triple-vessel coronary disease and an ejection fraction of 30% or less. The primary end point was the 30-day rate of death, MI, stroke, need for repeat revascularization, need for cardiovascular surgery or vascular surgery for limb ischemia, acute renal dysfunction, increased aortic insufficiency, severe hypotension, need for cardiopulmonary resuscitation, ventricular tachycardia, or failure to reopen the target coronaries by PCI.

The patients averaged 67 years old, 80% were men, and 56% had New York Heart Association class III or IV heart failure. Their average Society of Thoracic Surgeons (STS) mortality score was 6, their average SYNTAX (Synergy Between PCI With Taxus and Cardiac Surgery) score was 30, and 63% were considered ineligible for surgery. "The population was "extraordinarily high risk, the most complex patients ever enrolled in a multicenter, randomized, controlled trial, Dr. O’Neill said. There were 447 patients enrolled in PROTECT II before the study’s data and safety monitoring board stopped the trial last December. This number was 70% of the number of patients originally identified as needed to produce a statistically significant result for the primary end point. Enrollment into the study sharply slowed once the Impella device came onto the U.S. market in June 2008.

During PCI, the participating operators generally managed the Impella patients more aggressively. Heparin was given to 94% in the Impella arm and to 82% in the IABP control arm. Rotational atherectomy was performed in 15% of the Impella patients and in 10% of patients in the IABP arm, a statistically significant difference. Also, participating operators used atherectomy more aggressively in the Impella patients, with an average of five atherectomy passes per patient, compared with two passes in the IABP patients.

Although this shift in treatment approach may have ultimately benefited some of the Impella patients, it also "increased the major adverse event rate and confounded the analysis," Dr. O’Neill said. "About 70% of patients treated with atherectomy in the Impella group had an adverse event" – primarily rises in the level of creatine kinase–myoglobin – "compared with about 35% treated with atherectomy in the IABP group," he said in an interview. "It was a procedural imbalance that was hard to control for" in the safety and efficacy analysis.

There was no statistically significant difference for the study’s primary outcome, the combined major adverse event rate in the intention-to-treat analysis at 30 days after treatment, as well as at 90 days after treatment. However, at both time points, patients in the Impella arm showed trends toward lower major adverse events rates. At 30 days, the Impella patients had a 36% rate, compared with a 40% rate in the IABP patients. At 90 days, the rates reached 41% and 50%, respectively.

In the per-protocol analysis, at 30 days the Impella patients had a major adverse event rate of 35%, compared with 43% in the IABP patients, which was not a statistically significant difference. At 90 days, the rates reached 41% and 51% respectively, a difference that was statistically significant.

Dr. O’Neill addressed concerns that the major adverse event measure included many elements of sharply differing clinical importance. "What drove the difference [between the two study arms] was death, myocardial infarction, and need for urgent revascularization – not the small stuff. The real major adverse cardiac events were significantly better" when the Impella device was used, he said in an interview.

An analysis of several prespecified subgroups also highlighted certain types of patients who had significant benefit from the Impella device for the study’s primary end point. Among the 88% of patients in the study who were not treated with rotational atherectomy, the 30-day major adverse event rate reached 30%, compared with 42% in the IABP patients, a statistically significant difference. A significant difference in the primary outcome in favor of the Impella patients also occurred in the subgroup that had an STS mortality score lower than 10.

The results also showed a strong trend toward a better primary outcome in the Impella-treated patients when the analysis excluded the first Impella-treated patient for each operator, a finding that highlighted an important learning curve in using the device, Dr. O’Neill said.

Analysis also showed that the 90-day rate of major adverse events in the Impella patients fell from 48% in 2008 to 39% in 2009 and to 37% in 2010. In contrast, the rate in the IABP patients stayed fairly constant (at 47%-52%) in all 3 years, again highlighting the role of experience with the Impella device in achieving better patient outcomes, he said.

"I think many clinicians will see [from these data] that Impella provides a lot of safety," Dr. O’Neill said.

PROTECT II was sponsored by Abiomed, the company marketing the Impella 2.5 assist device. Dr. O’Neill said that he has been a consultant to Medtronic. Dr. Waksman said that he has been a consultant to or received honoraria from Medtronic Vascular, Abbott Vascular, Biotronik, Merck, and Boston Scientific.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Acute myocardial infarction patients treated with a drug-eluting coronary stent during a primary percutaneous coronary intervention had significantly better 5-year survival, compared with myocardial infarction patients who received a bare-metal stent, in a review of more than 12,000 patients treated in New Jersey during 2003-2004.

Although this analysis could not take into account selection biases that might have determined whether patients received drug-eluting or bare-metal stents, the findings in general provide reassurance about the safety of drug-eluting coronary stents for patients with an acute MI, Dr. Tudor D. Vagaonescu said at the annual meeting of the American College of Cardiology.

"These data are consistent with the idea that using drug-eluting stents in the setting of an acute MI is safe," said Dr. Vagaonescu, a cardiologist at the Robert Wood Johnson Medical School, New Brunswick, N.J.

"Our data show that preventing the need for revascularization [by using drug-eluting stents] helped with survival, although improved survival was likely due to a combination of things, including selection bias and the type of index event," he said in an interview.

But one expert who heard the findings remained unconvinced that drug-eluting coronary stents, especially the first-generation models (sirolimus- or paclitaxel-eluting) used during the era that the registry covered, have an advantage over bare-metal stents.

"These data don’t argue for using drug-eluting stents" for primary percutaneous coronary intervention (PCI), commented Dr. David G. Rizik, an interventional cardiologist and director of the division of heart and vascular medicine at the Scottsdale (Ariz.) Healthcare Hospital. "This was a retrospective review, and the MI population was very heterogeneous. Bare-metal stents have performed well in acute MI patients. If a physician has a doubt about a patient’s willingness or ability to comply with dual antiplatelet therapy, there is nothing wrong with using a bare-metal stent."

The study used data collected in the Myocardial Infarction Data Acquisition System (MIDAS) registry and included all patients who underwent primary PCI for an acute MI at a nonfederal hospital in New Jersey during 2003-2004. The group included 6,172 patients treated with one or more drug-eluting coronary stents only, and 5,833 patients treated with one or more bare-metal stents only. The analysis excluded patients who received both stent types.

Based on New Jersey death registration files, during the 5 years following stent placement, cumulative all-cause mortality in the drug-eluting stent recipients was 16% and was 20% in the bare-metal stent recipients, a statistically significant difference. The rate of cardiovascular death was 8% and 10% in the drug-eluting and bare-metal stent groups, respectively, also a statistically significant difference. Similar, statistically significant differences in favor of improved 5-year total survival and reduced cardiovascular deaths with drug-eluting stents also occurred in both the subset of patients with ST-elevation MI and in patients with non–ST-elevation MI, Dr. Vagaonescu reported.

He and his associates also performed multivariate analyses of mortality rates adjusted by age, sex, race, diabetes, hypertension, renal disease, anemia, cancer, cerebrovascular disease, prior MI, and treatment with a glycoprotein IIb/IIIa inhibitor. All of these multivariate analyses showed statistically significant survival advantages for the patients who received drug-eluting stents.

Another aspect of the analysis showed the dramatic shift toward use of drug-eluting stents for primary PCI during the period studied, which covered the time when the first sirolimus-eluting stent received Food and Drug Administration approval in April 2003, and when the first paclitaxel-eluting coronary stent received FDA approval in March 2004. In 2003, 73% of the 6,027 patients who received a single type of coronary stent for primary PCI in New Jersey received a bare-metal stent. By 2004, this pattern flipped, and 76% of the 5,978 patients who received a single type of coronary stent for primary PCI received a drug-eluting stent. Both years predated the reports in 2006 that first raised awareness of the risk for stent thrombosis in patients who received a drug-eluting stent, especially patients who prematurely stopped dual antiplatelet therapy.

Dr. Vagaonescu said that he had no disclosures. Dr. Rizik said that he had no disclosures.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – Elderly people with modestly elevated systolic blood pressures showed significant declines in their mobility and cognition, and concurrent significant increases in brain damage, during 2 years of follow-up in a small study.

These correlations suggest a possible new reason to control blood pressure in the elderly, Dr. William B. White said at the annual meeting of the American College of Cardiology.

"These data support an interventional trial evaluating different thresholds of ambulatory systolic blood pressure for preventing white matter progression and functional decline in older people," said Dr. White, professor of medicine and chief of the division of hypertension and clinical pharmacology at the University of Connecticut in Farmington.

He plans to compare target systolic blood pressures of 145 and 130 mm Hg, he said in an interview. "If you can intervene in patients with early-onset white matter disease and prevent progression, then you will do these people a big favor. I don’t think we will see regression [of white matter damage], just prevention of it getting worse. This is the first study I know of to longitudinally compare ambulatory blood pressure with both white matter hyperintensity and functional decline in older people. Blood pressure turned out to be the most important" determinant of declines in cognition and mobility and in an MRI measure of brain damage, "and blood pressure is something where we can intervene," he said.

"Hypertension specialists think about the burden [of hypertension] on the heart and the kidney, but they don’t think about the chronic burden on the brain," commented Dr. C. Venkata S. Ram, professor of medicine at the University of Texas Southwestern Medical Center in Dallas. "Chronic hypertension can lead to significant morphologic and physiologic dysfunction. Many patients diagnosed with Alzheimer’s disease probably had poorly controlled hypertension over their lifetime."

Dr. White and his associates enrolled 72 people aged 75-89 with various degrees of mobility and cognitive impairment who underwent blood pressure, cognitive, mobility, and MRI brain assessments at entry and 24 months later. At baseline, their age averaged 82 years, their 24-hour ambulatory blood pressure averaged 126/66 mm Hg, and their average amount of brain white matter hyperintensity, a marker of brain damage, was 1% of their total brain volume. Two years later, their average ambulatory blood pressure stood at 131/67 mm Hg. At both times, about 70% of patients received antihypertensive medication.

When the researchers compared the findings at the two measurement times, they found that for each 1% increase in the volume of white matter hyperintensity, subjects showed an average 0.31-second decrease in their walk time and a 33-millisecond increase in their simple reaction time on cognitive testing. In addition, for each 1–mm Hg increase in 24-hour systolic blood pressure over the 2-year period between measurements, the subjects had an average 0.04% increase in their volume of white matter hypertrophy.

In a different analysis, Dr. White and his associates divided the 72 people into tertiles based on their 24-hour systolic blood pressure at their 2-year assessment. The top and bottom tertiles had average systolic pressures of 144 and 117 mm Hg. The top tertile showed a significantly larger increase in white matter hyperintensity volume over the 2 years of follow-up, a significantly longer 8-foot walk time, a significantly slower walking speed, and nonsignificant trend toward poorer results on cognition tests.

Also notable in the findings was that a modest level of systolic hypertension in the highest tertile linked with significant changes over the 2-year period. "The people only averaged 144 mm Hg. That’s not so bad, but they had progression," Dr. White said.

He said that he has been a consultant to the Forest Research Institute and has received research grants from Novartis.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.

NEW ORLEANS – General practice physicians who managed stable heart failure patients achieved long-term outcomes that matched the outcomes of patients managed in specialized, outpatient heart failure clinics supervised by cardiologists, in a randomized, Danish study with more than 1,100 patients.

Another facet of the same study showed that repeated, serial measurement of blood levels of N-terminal-proB-type natriuretic peptide (NT-proBNP) in heart failure patients did not improve long-term outcomes compared with no routine measurement of the biomarker, Dr. Morten Schou said at the annual meeting of the American College of Cardiology.

"Clinically stable patients with systolic heart failure on optimal medical therapy did not benefit from long-term follow-up in a heart failure clinic," said Dr. Schou, a cardiologist at Hillerod University Hospital in Copenhagen.

Heart failure clinics with intensive patient management can aid in stabilizing patients, but they are most suited for newly diagnosed patients who are not yet well controlled on an appropriate maintenance regimen, Dr. Schou said in an interview. "Our study is the first to investigate continuing intensive management once a heart failure patient is stable on an optimized regimen. The long-term benefits of heart failure clinics were never tested before."

The stabilization regimen used by Dr. Schou and his associates involved uptitrating the drugs patients received so that their medical treatment used drugs such as angiotensin converting enzyme (ACE) inhibitors, beta-blockers, and aldosterone antagonists at dosages comparable to what has been shown effective in clinical trials. Patients also received comprehensive education about their heart failure and optimal management methods. The stabilization process took from 1 month to 1 year, he said, and slightly more than a quarter of the heart failure patients seen at least once at one of the 18 participating Danish heart failure clinics achieved stability and also met the study’s other eligibility criteria.

"The key message is that you need to educate and uptitrate patients, and then they can be followed by a general practitioner," he said.

The second finding of the study, that multiple, serial measures of blood NT-proBNP did not lead to improved outcomes, should prompt a change in U.S. practice, commented Dr. Prakash C.Deedwania, professor of medicine at the University of California, San Francisco, in Fresno.

In current U.S. practice, "BNP is measured about 10 times on patients in the hospital [for heart failure]. I could never understand it. These results show that it wastes time and money to measure BNP" repeatedly, he said in an interview.

The NT-proBNP stratified follow-up in outpatient heart failure clinics (NorthStar) trial enrolled patients with New York Heart Association class I-III systolic heart failure and a left ventricular ejection fraction of 45% or less who also fulfilled the study’s prespecified criteria for disease stability. The criteria included completion of a heart failure education course, and daily treatment with an evidence-based dosage of an ACE inhibitor or angiotensin II receptor blocker (ARB), beta-blocker, and, when appropriate, an aldosterone antagonist. Participants were also taking a stable diuretic dose and had a stable weight, stable heart failure symptoms, and no crackles on lung auscultation. The study randomized 460 patients to ongoing care by a general practitioner and 659 patients to regular care in a heart failure clinic supervised by a cardiologist.

The heart failure clinic patients underwent further assessment at baseline to identify those with a blood level of NT-proBNP that exceeded 1,000 pg/mL. The 407 patients in this group underwent a second randomization, with 208 patients followed without any subsequent, routine measurement of their NT-proBNP level, and 199 patients who underwent a repeat blood check of NT-proBNP at every follow-up visit to the clinic. The clinic staff received a guide detailing clinical factors to investigate in patients who had a rise in their NT-proBNP level of greater than 30% from one clinic visit to the next. The study followed all patients for a median of 2.5 years.

The average age of the patients randomized to GP or heart failure clinic management was 69 years. A quarter of the patients were women, and all patients had an average ejection fraction of about 31%. Among the subgroup of patients with an elevated blood level of NT-proBNP at baseline, the average age was 73 years, a quarter were women, and their average ejection fraction was 30%.

The study’s primary end point was the combined rate of all-cause death or cardiovascular hospitalization. After a median of 2.8 years, low-risk patients had 27 deaths and 81 composite events in the GP group vs. 22 deaths and 92 composite events in the clinic group. High-risk patients had 37 deaths and 78 composite events in the GP group and 38 deaths and 85 composite events in the clinic. In addition, patients managed in heart failure clinics without routine NT-proBNP monitoring had a combined end point rate similar to those who underwent routine monitoring, Dr. Schou reported. The results showed no statistically significant difference among the study subgroups for any secondary end points assessed.

Dr. Schou said that he has received research support from Roche Diagnostics Denmark, Roche Diagnostics International, and Merck Sharp & Dohme.