ACC 2012

CHICAGO – Acute myocardial infarction patients who have diabetes are less likely to present with an ST-elevation MI, yet they run a significantly increased risk for in-hospital death, compared with nondiabetic MI patients.

Moreover, MI patients with diabetes are more likely to experience in-hospital stroke, recurrent MI, and heart failure or pulmonary edema, according to Dr. Quang T. Bui of Harbor-UCLA Medical Center, Los Angeles.

Dr. Bui presented an analysis of 232,927 patients presenting with acute MI to 823 hospitals participating in the National Registry of Myocardial Infarction (NRMI) 4-5. A history of diabetes was noted in 31%.

The in-hospital mortality rate was 10.1% in diabetic patients and 8.3% in nondiabetic patients. In-hospital strokes occurred in 1.4% of diabetics compared with 1.0% of nondiabetic patients. The in-hospital rate of recurrent MI was 1.5% in the diabetic patients and 1.3% in those without diabetes.

Diabetes patients hospitalized for MI had an 18% greater risk of in-hospital mortality than did nondiabetic patients. They also had a 30% greater risk of in-hospital stroke, a 14% increased risk of in-hospital recurrent MI, and a 57% greater risk of developing in-hospital heart failure or pulmonary edema.

An ST-elevation MI occurred in 31% of diabetic patients and 40% of nondiabetic patients. Anterior/septal MI occurred in 14.7% of diabetic MI patients and 18.9% of those without diabetes. However, 11.5% of MI patients with diabetes were Killup class III/IV, compared with 6.5% of those without diabetes.

A history of previous MI was present in 31% of diabetic patients compared with 22% of those without diabetes. The diabetic group also had significantly higher rates of background hypercholesterolemia, hypertension, renal dysfunction, previous revascularization, and prior stroke.

Preadmission use of cardiovascular risk-reducing medications was more common among the diabetic MI patients. Yet the use of these agents was actually low given that diabetes is a well-recognized risk factor for cardiovascular disease, Dr. Bui observed. Less than half of diabetic MI patients were on an ACE inhibitor or an angiotensin receptor blocker prior to their hospitalization for an MI. About 30% were taking a beta-blocker. A similar proportion of patients used a statin or other lipid-lowering agent.

Health care planners will be particularly interested in the NRMI 4-5 finding that the mean hospital length of stay was 6.5 days in acute MI patients with diabetes, compared with 5.2 days in those without a history of diabetes, Dr. Bui noted. Diabetes patients with a history of MI were hospitalized for about 20 hours longer than were nondiabetic patients with a prior MI. And diabetes patients without a prior MI were hospitalized for 14 hours longer than were nondiabetic patients with a history of MI, Dr. Bui said.

The NRMI project is funded by Genentech. Dr. Bui reported having no financial conflicts.

CHICAGO – Acute myocardial infarction patients who have diabetes are less likely to present with an ST-elevation MI, yet they run a significantly increased risk for in-hospital death, compared with nondiabetic MI patients.

Moreover, MI patients with diabetes are more likely to experience in-hospital stroke, recurrent MI, and heart failure or pulmonary edema, according to Dr. Quang T. Bui of Harbor-UCLA Medical Center, Los Angeles.

Dr. Bui presented an analysis of 232,927 patients presenting with acute MI to 823 hospitals participating in the National Registry of Myocardial Infarction (NRMI) 4-5. A history of diabetes was noted in 31%.

The in-hospital mortality rate was 10.1% in diabetic patients and 8.3% in nondiabetic patients. In-hospital strokes occurred in 1.4% of diabetics compared with 1.0% of nondiabetic patients. The in-hospital rate of recurrent MI was 1.5% in the diabetic patients and 1.3% in those without diabetes.

Diabetes patients hospitalized for MI had an 18% greater risk of in-hospital mortality than did nondiabetic patients. They also had a 30% greater risk of in-hospital stroke, a 14% increased risk of in-hospital recurrent MI, and a 57% greater risk of developing in-hospital heart failure or pulmonary edema.

An ST-elevation MI occurred in 31% of diabetic patients and 40% of nondiabetic patients. Anterior/septal MI occurred in 14.7% of diabetic MI patients and 18.9% of those without diabetes. However, 11.5% of MI patients with diabetes were Killup class III/IV, compared with 6.5% of those without diabetes.

A history of previous MI was present in 31% of diabetic patients compared with 22% of those without diabetes. The diabetic group also had significantly higher rates of background hypercholesterolemia, hypertension, renal dysfunction, previous revascularization, and prior stroke.

Preadmission use of cardiovascular risk-reducing medications was more common among the diabetic MI patients. Yet the use of these agents was actually low given that diabetes is a well-recognized risk factor for cardiovascular disease, Dr. Bui observed. Less than half of diabetic MI patients were on an ACE inhibitor or an angiotensin receptor blocker prior to their hospitalization for an MI. About 30% were taking a beta-blocker. A similar proportion of patients used a statin or other lipid-lowering agent.

Health care planners will be particularly interested in the NRMI 4-5 finding that the mean hospital length of stay was 6.5 days in acute MI patients with diabetes, compared with 5.2 days in those without a history of diabetes, Dr. Bui noted. Diabetes patients with a history of MI were hospitalized for about 20 hours longer than were nondiabetic patients with a prior MI. And diabetes patients without a prior MI were hospitalized for 14 hours longer than were nondiabetic patients with a history of MI, Dr. Bui said.

The NRMI project is funded by Genentech. Dr. Bui reported having no financial conflicts.

CHICAGO – Acute myocardial infarction patients who have diabetes are less likely to present with an ST-elevation MI, yet they run a significantly increased risk for in-hospital death, compared with nondiabetic MI patients.

Moreover, MI patients with diabetes are more likely to experience in-hospital stroke, recurrent MI, and heart failure or pulmonary edema, according to Dr. Quang T. Bui of Harbor-UCLA Medical Center, Los Angeles.

Dr. Bui presented an analysis of 232,927 patients presenting with acute MI to 823 hospitals participating in the National Registry of Myocardial Infarction (NRMI) 4-5. A history of diabetes was noted in 31%.

The in-hospital mortality rate was 10.1% in diabetic patients and 8.3% in nondiabetic patients. In-hospital strokes occurred in 1.4% of diabetics compared with 1.0% of nondiabetic patients. The in-hospital rate of recurrent MI was 1.5% in the diabetic patients and 1.3% in those without diabetes.

Diabetes patients hospitalized for MI had an 18% greater risk of in-hospital mortality than did nondiabetic patients. They also had a 30% greater risk of in-hospital stroke, a 14% increased risk of in-hospital recurrent MI, and a 57% greater risk of developing in-hospital heart failure or pulmonary edema.

An ST-elevation MI occurred in 31% of diabetic patients and 40% of nondiabetic patients. Anterior/septal MI occurred in 14.7% of diabetic MI patients and 18.9% of those without diabetes. However, 11.5% of MI patients with diabetes were Killup class III/IV, compared with 6.5% of those without diabetes.

A history of previous MI was present in 31% of diabetic patients compared with 22% of those without diabetes. The diabetic group also had significantly higher rates of background hypercholesterolemia, hypertension, renal dysfunction, previous revascularization, and prior stroke.

Preadmission use of cardiovascular risk-reducing medications was more common among the diabetic MI patients. Yet the use of these agents was actually low given that diabetes is a well-recognized risk factor for cardiovascular disease, Dr. Bui observed. Less than half of diabetic MI patients were on an ACE inhibitor or an angiotensin receptor blocker prior to their hospitalization for an MI. About 30% were taking a beta-blocker. A similar proportion of patients used a statin or other lipid-lowering agent.

Health care planners will be particularly interested in the NRMI 4-5 finding that the mean hospital length of stay was 6.5 days in acute MI patients with diabetes, compared with 5.2 days in those without a history of diabetes, Dr. Bui noted. Diabetes patients with a history of MI were hospitalized for about 20 hours longer than were nondiabetic patients with a prior MI. And diabetes patients without a prior MI were hospitalized for 14 hours longer than were nondiabetic patients with a history of MI, Dr. Bui said.

The NRMI project is funded by Genentech. Dr. Bui reported having no financial conflicts.

When researchers reported earlier this week at the American College of Cardiology’s annual meeting results from the TRA 2P-TIMI 50 trial, which tested a novel anticoagulant drug, vorapaxar, for preventing cardiovascular death, myocardial infarction (MI), and stroke in stable patients with cardiovascular disease, the results showed a questionable balance between benefit and bleeding risk that only looked good if you squinted and confined the analysis to patients with just a history of MI, no history of stroke, a body weight of at least 60 kg, and, ideally, those who were younger than 75 years old. Even within this pared-down universe, experts differed on whether vorapaxar had an unequivocal net benefit after taking into account the bleeding risk it caused.

Photo courtesyCDC/Janice Carr

But if vorapaxar someday gets FDA approval and appears on the U.S. market, physicians will face the tricky calculus of how to use it, compared with the other new, potent antithrombotic drugs.

Looking at vorapaxar’s performance in patients with stable cardiovascular disease, it was hard not to recall last November’s report on the ATLAS ACS 2-TIMI 51 trial, which tested adding a 2.5 mg b.i.d. dosage of another new anticoagulant drug, rivaroxaban, in acute coronary syndrome (ACS) patients also treated with aspirin and clopidogrel. In ATLAS, adding this small dose of rivaroxaban led to benefit and a bleeding risk that was strikingly similar to the pattern seen with vorapaxar in TRA 2P. Rivaroxaban on top of aspirin and clopidogrel produced an absolute 1.6% cut in the combined rate of cardiovascular death, MI, or stroke while boosting the rate of major bleeds by an absolute 1.2%, and the rate of intracranial bleeds by 0.2%. The new vorapaxar results showed that in the best-case subgroup, adding the drug to aspirin and clopidogrel cut cardiovascular death, MI, or stroke by an absolute 1.9%, while boosting major bleeds by 1.0% and intracranial hemorrhage by 0.2%.

A big difference in the two analyses was that the benefits and risk seen with 2.5 mg rivaroxaban was in the entire study population of 5,100 patients, with no need to resort to subgroup analyses. The vorapaxar result was in about 9,500 patients, roughly 70% of all patients enrolled in the trial. Another big difference was the major impact of rivaroxaban was on cutting cardiovascular deaths. Vorapaxar’s main effect was to lower nonfatal MIs. It cut cardiovascular deaths, too, but not as well as low-dose rivaroxaban.

Many experts whom I spoke with at the meeting seemed confident that low-dose rivaroxaban is on track for FDA approval later this year for treating ACS patients. Whether Merck, the company developing vorapaxar, will seek FDA approval for its drug in stable patients based on the TRA 2P data remains to be seen.

But while rivaroxaban won’t receive labeling for treating non-ACS patients, all that separates an ACS patient and a patient who is stable but with a history of prior MI is time; in fact, just a few weeks or months. The point at which an acute ACS patient becomes a stable, post-MI patient is pretty murky. Would anyone consider treating a stable, post-ACS patient with low-dose rivaroxaban? The labeling probably won’t cover it, but will the temptation be there? And the what-ifs don’t stop there.

Both the low-dose rivaroxaban study and the vorapaxar study used aspirin and clopidogrel as standard, background treatment. But U.S. physicians are increasingly switching from clopidogrel to the newer, more potent antiplatelet drugs already on the market, prasugreland ticagrelor, several experts told me at ACC. Putting a patient on prasugrel or ticagrelor plus aspirin will likely preclude any thought of also adding rivaroxaban, not to mention vorapaxar. These combinations have not been tested, and given the bleeding risks that these drugs pose individually, the idea of using them in combination is downright scary.

After several years when clopidogrel plus aspirin reigned alone as the top treatment for preventing atherothrombotic events, the last few years brought a flurry of new agents. How these drugs compare and relate to each other, and how they are optimally used alone or in combination, will take several more years to sort out.

-- Mitchel L. Zoler (Twitter @mitchelzoler)

When researchers reported earlier this week at the American College of Cardiology’s annual meeting results from the TRA 2P-TIMI 50 trial, which tested a novel anticoagulant drug, vorapaxar, for preventing cardiovascular death, myocardial infarction (MI), and stroke in stable patients with cardiovascular disease, the results showed a questionable balance between benefit and bleeding risk that only looked good if you squinted and confined the analysis to patients with just a history of MI, no history of stroke, a body weight of at least 60 kg, and, ideally, those who were younger than 75 years old. Even within this pared-down universe, experts differed on whether vorapaxar had an unequivocal net benefit after taking into account the bleeding risk it caused.

Photo courtesyCDC/Janice Carr

But if vorapaxar someday gets FDA approval and appears on the U.S. market, physicians will face the tricky calculus of how to use it, compared with the other new, potent antithrombotic drugs.

Looking at vorapaxar’s performance in patients with stable cardiovascular disease, it was hard not to recall last November’s report on the ATLAS ACS 2-TIMI 51 trial, which tested adding a 2.5 mg b.i.d. dosage of another new anticoagulant drug, rivaroxaban, in acute coronary syndrome (ACS) patients also treated with aspirin and clopidogrel. In ATLAS, adding this small dose of rivaroxaban led to benefit and a bleeding risk that was strikingly similar to the pattern seen with vorapaxar in TRA 2P. Rivaroxaban on top of aspirin and clopidogrel produced an absolute 1.6% cut in the combined rate of cardiovascular death, MI, or stroke while boosting the rate of major bleeds by an absolute 1.2%, and the rate of intracranial bleeds by 0.2%. The new vorapaxar results showed that in the best-case subgroup, adding the drug to aspirin and clopidogrel cut cardiovascular death, MI, or stroke by an absolute 1.9%, while boosting major bleeds by 1.0% and intracranial hemorrhage by 0.2%.

A big difference in the two analyses was that the benefits and risk seen with 2.5 mg rivaroxaban was in the entire study population of 5,100 patients, with no need to resort to subgroup analyses. The vorapaxar result was in about 9,500 patients, roughly 70% of all patients enrolled in the trial. Another big difference was the major impact of rivaroxaban was on cutting cardiovascular deaths. Vorapaxar’s main effect was to lower nonfatal MIs. It cut cardiovascular deaths, too, but not as well as low-dose rivaroxaban.

Many experts whom I spoke with at the meeting seemed confident that low-dose rivaroxaban is on track for FDA approval later this year for treating ACS patients. Whether Merck, the company developing vorapaxar, will seek FDA approval for its drug in stable patients based on the TRA 2P data remains to be seen.

But while rivaroxaban won’t receive labeling for treating non-ACS patients, all that separates an ACS patient and a patient who is stable but with a history of prior MI is time; in fact, just a few weeks or months. The point at which an acute ACS patient becomes a stable, post-MI patient is pretty murky. Would anyone consider treating a stable, post-ACS patient with low-dose rivaroxaban? The labeling probably won’t cover it, but will the temptation be there? And the what-ifs don’t stop there.

Both the low-dose rivaroxaban study and the vorapaxar study used aspirin and clopidogrel as standard, background treatment. But U.S. physicians are increasingly switching from clopidogrel to the newer, more potent antiplatelet drugs already on the market, prasugreland ticagrelor, several experts told me at ACC. Putting a patient on prasugrel or ticagrelor plus aspirin will likely preclude any thought of also adding rivaroxaban, not to mention vorapaxar. These combinations have not been tested, and given the bleeding risks that these drugs pose individually, the idea of using them in combination is downright scary.

After several years when clopidogrel plus aspirin reigned alone as the top treatment for preventing atherothrombotic events, the last few years brought a flurry of new agents. How these drugs compare and relate to each other, and how they are optimally used alone or in combination, will take several more years to sort out.

-- Mitchel L. Zoler (Twitter @mitchelzoler)

When researchers reported earlier this week at the American College of Cardiology’s annual meeting results from the TRA 2P-TIMI 50 trial, which tested a novel anticoagulant drug, vorapaxar, for preventing cardiovascular death, myocardial infarction (MI), and stroke in stable patients with cardiovascular disease, the results showed a questionable balance between benefit and bleeding risk that only looked good if you squinted and confined the analysis to patients with just a history of MI, no history of stroke, a body weight of at least 60 kg, and, ideally, those who were younger than 75 years old. Even within this pared-down universe, experts differed on whether vorapaxar had an unequivocal net benefit after taking into account the bleeding risk it caused.

Photo courtesyCDC/Janice Carr

But if vorapaxar someday gets FDA approval and appears on the U.S. market, physicians will face the tricky calculus of how to use it, compared with the other new, potent antithrombotic drugs.

Looking at vorapaxar’s performance in patients with stable cardiovascular disease, it was hard not to recall last November’s report on the ATLAS ACS 2-TIMI 51 trial, which tested adding a 2.5 mg b.i.d. dosage of another new anticoagulant drug, rivaroxaban, in acute coronary syndrome (ACS) patients also treated with aspirin and clopidogrel. In ATLAS, adding this small dose of rivaroxaban led to benefit and a bleeding risk that was strikingly similar to the pattern seen with vorapaxar in TRA 2P. Rivaroxaban on top of aspirin and clopidogrel produced an absolute 1.6% cut in the combined rate of cardiovascular death, MI, or stroke while boosting the rate of major bleeds by an absolute 1.2%, and the rate of intracranial bleeds by 0.2%. The new vorapaxar results showed that in the best-case subgroup, adding the drug to aspirin and clopidogrel cut cardiovascular death, MI, or stroke by an absolute 1.9%, while boosting major bleeds by 1.0% and intracranial hemorrhage by 0.2%.

A big difference in the two analyses was that the benefits and risk seen with 2.5 mg rivaroxaban was in the entire study population of 5,100 patients, with no need to resort to subgroup analyses. The vorapaxar result was in about 9,500 patients, roughly 70% of all patients enrolled in the trial. Another big difference was the major impact of rivaroxaban was on cutting cardiovascular deaths. Vorapaxar’s main effect was to lower nonfatal MIs. It cut cardiovascular deaths, too, but not as well as low-dose rivaroxaban.

Many experts whom I spoke with at the meeting seemed confident that low-dose rivaroxaban is on track for FDA approval later this year for treating ACS patients. Whether Merck, the company developing vorapaxar, will seek FDA approval for its drug in stable patients based on the TRA 2P data remains to be seen.

But while rivaroxaban won’t receive labeling for treating non-ACS patients, all that separates an ACS patient and a patient who is stable but with a history of prior MI is time; in fact, just a few weeks or months. The point at which an acute ACS patient becomes a stable, post-MI patient is pretty murky. Would anyone consider treating a stable, post-ACS patient with low-dose rivaroxaban? The labeling probably won’t cover it, but will the temptation be there? And the what-ifs don’t stop there.

Both the low-dose rivaroxaban study and the vorapaxar study used aspirin and clopidogrel as standard, background treatment. But U.S. physicians are increasingly switching from clopidogrel to the newer, more potent antiplatelet drugs already on the market, prasugreland ticagrelor, several experts told me at ACC. Putting a patient on prasugrel or ticagrelor plus aspirin will likely preclude any thought of also adding rivaroxaban, not to mention vorapaxar. These combinations have not been tested, and given the bleeding risks that these drugs pose individually, the idea of using them in combination is downright scary.

After several years when clopidogrel plus aspirin reigned alone as the top treatment for preventing atherothrombotic events, the last few years brought a flurry of new agents. How these drugs compare and relate to each other, and how they are optimally used alone or in combination, will take several more years to sort out.

-- Mitchel L. Zoler (Twitter @mitchelzoler)

CHICAGO – A very active, low-technology quality improvement program can improve the uptake of evidence-based therapies for acute coronary syndrome in public hospitals, results of the BRIDGE-ACS study show.

Patients at hospitals randomized to the multiphase program were twice as likely to receive all evidence-based therapies including aspirin, clopidogrel (Plavix), anticoagulants, and statins within the first 24 hours.

Although BRIDGE-ACS (Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes) was not powered to evaluate clinical outcomes, all trended in the right direction, co-principal investigator Dr. Otávio Berwanger said at the annual meeting of the American College of Cardiology.

Patrice Wendling/IMNG Medical Media

"Because it is simple and feasible, the tools tested in the BRIDGE-ACS trial can become the basis for developing quality-improvement programs to maximize the use of evidence-based interventions for the management of acute coronary syndromes," he said.

Registries in several countries have shown consistently that the translation of research findings into practice is suboptimal. These care gaps are an even bigger problem in low- and middle-income countries, where up to 80% of the global burden of cardiovascular disease resides, observed Dr. Berwanger of the Hospital do Coração, São Paulo, Brazil.

BRIDGE-ACS randomized 34 public general hospitals from major urban areas in Brazil to routine practice or the intervention. A total of 1,150 consecutive ACS patients were treated during March-November 2011. Their mean age was 62 years, and about 40% presented with ST-segment elevation myocardial infarction (STEMI), 36% presented with non-STEMI, and 24% had unstable angina.

For the intervention, triage nurses identified ACS patients by placing a yellow "chest pain" sticker on their chart, and evaluating physicians were given a checklist consistent with national guidelines. The charts were coded green, yellow, and red to denote a scale from no chest pain to severe pain, and patients were given colored bracelets that matched the risk category to serve as simple reminders throughout their hospital stay, Dr. Berwanger explained.

The most important element of the intervention program was the use of specially trained nurse–case managers to ensure that all components of the intervention were being used and who followed the patients from the emergency room until discharge, he said.

Less-active components of the program included providing educational materials such as pocket guidelines, posters, and websites that contained evidence-based recommendations for the management of patients with ACS.

"As you see, it’s complex, but it doesn’t rely on complex and expensive technology," Dr. Berwanger remarked.

Among the 80% of patients without contraindications, adherence to all evidence-based therapies in the first 24 hours was 67.9% at the intervention hospitals and 49.5% at the control hospitals, a significant difference. The results remained significant when the analysis excluded statins (78% vs. 58%), which are not critical in the first 24 hours, he said.

Eligible patients were also significantly more likely at the intervention hospitals to receive all acute and discharge medications (51% vs. 32%), even after excluding statins.

Patrice Wendling/IMNG Medical Media

"One of the key findings of your study is not the 24-hour results, but that more patients at discharge are actually on the right therapy," said discussant Dr. Erik Magnus Ohman of Duke University, Durham, N.C. "It tells us that if you get it right from the beginning, the patients are going to stay on the right track. It’s very important."

The mean Composite Adherence Score was significantly higher at the intervention hospitals, at 89%, than at the control hospital, at 81.4%.

A subgroup analysis showed that the intervention had a larger effect in hospitals with percutaneous coronary intervention capabilities (odds ratio, 7.97) and in patients with a final diagnosis of non-STEMI (OR, 3.47), Dr. Berwanger said.

Session co-moderator Dr. Robert Harrington, director of Duke Clinical Research Institute, asked which component of the intervention really made the difference and whether a case manager who follows ACS patients throughout the hospital is sustainable.

Dr. Berwanger replied that the dedicated nurse–case manager is the key. He acknowledges that this is challenging and costly to sustain because he or she should be exempt from performing other duties, but says hospital managers and chief operating officers may become convinced and hire such staff if they start seeing the difference in quality.

At 30 days, there was a nonsignificant trend favoring the intervention hospitals over controls for major cardiovascular adverse events (5.5% vs. 7%), cardiovascular mortality (6.6% vs. 7.1%), and total mortality (7.0% vs. 8.4%).

Rates of in-hospital major bleeding events higher in the intervention group, driven largely by higher use of anticoagulants and statins, but was not significant (1.2% vs. 0.2%), Dr. Berwanger reported.

He said the investigators are continuing to follow patients at the participating hospitals as part of an observational study and are meeting with the Brazilian Health Ministry to fund a BRIDGE-ACS II trial to assess clinical outcomes of ACS.

The study was simultaneously published (JAMA 2012 [doi:10.1001/jama.2012.413]).

This study is funded by the Brazilian Ministry of Health in partnership with Hospital do Coração. Dr. Berwanger reported no competing interests.

CHICAGO – A very active, low-technology quality improvement program can improve the uptake of evidence-based therapies for acute coronary syndrome in public hospitals, results of the BRIDGE-ACS study show.

Patients at hospitals randomized to the multiphase program were twice as likely to receive all evidence-based therapies including aspirin, clopidogrel (Plavix), anticoagulants, and statins within the first 24 hours.

Although BRIDGE-ACS (Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes) was not powered to evaluate clinical outcomes, all trended in the right direction, co-principal investigator Dr. Otávio Berwanger said at the annual meeting of the American College of Cardiology.

Patrice Wendling/IMNG Medical Media

"Because it is simple and feasible, the tools tested in the BRIDGE-ACS trial can become the basis for developing quality-improvement programs to maximize the use of evidence-based interventions for the management of acute coronary syndromes," he said.

Registries in several countries have shown consistently that the translation of research findings into practice is suboptimal. These care gaps are an even bigger problem in low- and middle-income countries, where up to 80% of the global burden of cardiovascular disease resides, observed Dr. Berwanger of the Hospital do Coração, São Paulo, Brazil.

BRIDGE-ACS randomized 34 public general hospitals from major urban areas in Brazil to routine practice or the intervention. A total of 1,150 consecutive ACS patients were treated during March-November 2011. Their mean age was 62 years, and about 40% presented with ST-segment elevation myocardial infarction (STEMI), 36% presented with non-STEMI, and 24% had unstable angina.

For the intervention, triage nurses identified ACS patients by placing a yellow "chest pain" sticker on their chart, and evaluating physicians were given a checklist consistent with national guidelines. The charts were coded green, yellow, and red to denote a scale from no chest pain to severe pain, and patients were given colored bracelets that matched the risk category to serve as simple reminders throughout their hospital stay, Dr. Berwanger explained.

The most important element of the intervention program was the use of specially trained nurse–case managers to ensure that all components of the intervention were being used and who followed the patients from the emergency room until discharge, he said.

Less-active components of the program included providing educational materials such as pocket guidelines, posters, and websites that contained evidence-based recommendations for the management of patients with ACS.

"As you see, it’s complex, but it doesn’t rely on complex and expensive technology," Dr. Berwanger remarked.

Among the 80% of patients without contraindications, adherence to all evidence-based therapies in the first 24 hours was 67.9% at the intervention hospitals and 49.5% at the control hospitals, a significant difference. The results remained significant when the analysis excluded statins (78% vs. 58%), which are not critical in the first 24 hours, he said.

Eligible patients were also significantly more likely at the intervention hospitals to receive all acute and discharge medications (51% vs. 32%), even after excluding statins.

Patrice Wendling/IMNG Medical Media

"One of the key findings of your study is not the 24-hour results, but that more patients at discharge are actually on the right therapy," said discussant Dr. Erik Magnus Ohman of Duke University, Durham, N.C. "It tells us that if you get it right from the beginning, the patients are going to stay on the right track. It’s very important."

The mean Composite Adherence Score was significantly higher at the intervention hospitals, at 89%, than at the control hospital, at 81.4%.

A subgroup analysis showed that the intervention had a larger effect in hospitals with percutaneous coronary intervention capabilities (odds ratio, 7.97) and in patients with a final diagnosis of non-STEMI (OR, 3.47), Dr. Berwanger said.

Session co-moderator Dr. Robert Harrington, director of Duke Clinical Research Institute, asked which component of the intervention really made the difference and whether a case manager who follows ACS patients throughout the hospital is sustainable.

Dr. Berwanger replied that the dedicated nurse–case manager is the key. He acknowledges that this is challenging and costly to sustain because he or she should be exempt from performing other duties, but says hospital managers and chief operating officers may become convinced and hire such staff if they start seeing the difference in quality.

At 30 days, there was a nonsignificant trend favoring the intervention hospitals over controls for major cardiovascular adverse events (5.5% vs. 7%), cardiovascular mortality (6.6% vs. 7.1%), and total mortality (7.0% vs. 8.4%).

Rates of in-hospital major bleeding events higher in the intervention group, driven largely by higher use of anticoagulants and statins, but was not significant (1.2% vs. 0.2%), Dr. Berwanger reported.

He said the investigators are continuing to follow patients at the participating hospitals as part of an observational study and are meeting with the Brazilian Health Ministry to fund a BRIDGE-ACS II trial to assess clinical outcomes of ACS.

The study was simultaneously published (JAMA 2012 [doi:10.1001/jama.2012.413]).

This study is funded by the Brazilian Ministry of Health in partnership with Hospital do Coração. Dr. Berwanger reported no competing interests.

CHICAGO – A very active, low-technology quality improvement program can improve the uptake of evidence-based therapies for acute coronary syndrome in public hospitals, results of the BRIDGE-ACS study show.

Patients at hospitals randomized to the multiphase program were twice as likely to receive all evidence-based therapies including aspirin, clopidogrel (Plavix), anticoagulants, and statins within the first 24 hours.

Although BRIDGE-ACS (Brazilian Intervention to Increase Evidence Usage in Acute Coronary Syndromes) was not powered to evaluate clinical outcomes, all trended in the right direction, co-principal investigator Dr. Otávio Berwanger said at the annual meeting of the American College of Cardiology.

Patrice Wendling/IMNG Medical Media

"Because it is simple and feasible, the tools tested in the BRIDGE-ACS trial can become the basis for developing quality-improvement programs to maximize the use of evidence-based interventions for the management of acute coronary syndromes," he said.

Registries in several countries have shown consistently that the translation of research findings into practice is suboptimal. These care gaps are an even bigger problem in low- and middle-income countries, where up to 80% of the global burden of cardiovascular disease resides, observed Dr. Berwanger of the Hospital do Coração, São Paulo, Brazil.

BRIDGE-ACS randomized 34 public general hospitals from major urban areas in Brazil to routine practice or the intervention. A total of 1,150 consecutive ACS patients were treated during March-November 2011. Their mean age was 62 years, and about 40% presented with ST-segment elevation myocardial infarction (STEMI), 36% presented with non-STEMI, and 24% had unstable angina.

For the intervention, triage nurses identified ACS patients by placing a yellow "chest pain" sticker on their chart, and evaluating physicians were given a checklist consistent with national guidelines. The charts were coded green, yellow, and red to denote a scale from no chest pain to severe pain, and patients were given colored bracelets that matched the risk category to serve as simple reminders throughout their hospital stay, Dr. Berwanger explained.

The most important element of the intervention program was the use of specially trained nurse–case managers to ensure that all components of the intervention were being used and who followed the patients from the emergency room until discharge, he said.

Less-active components of the program included providing educational materials such as pocket guidelines, posters, and websites that contained evidence-based recommendations for the management of patients with ACS.

"As you see, it’s complex, but it doesn’t rely on complex and expensive technology," Dr. Berwanger remarked.

Among the 80% of patients without contraindications, adherence to all evidence-based therapies in the first 24 hours was 67.9% at the intervention hospitals and 49.5% at the control hospitals, a significant difference. The results remained significant when the analysis excluded statins (78% vs. 58%), which are not critical in the first 24 hours, he said.

Eligible patients were also significantly more likely at the intervention hospitals to receive all acute and discharge medications (51% vs. 32%), even after excluding statins.

Patrice Wendling/IMNG Medical Media

"One of the key findings of your study is not the 24-hour results, but that more patients at discharge are actually on the right therapy," said discussant Dr. Erik Magnus Ohman of Duke University, Durham, N.C. "It tells us that if you get it right from the beginning, the patients are going to stay on the right track. It’s very important."

The mean Composite Adherence Score was significantly higher at the intervention hospitals, at 89%, than at the control hospital, at 81.4%.

A subgroup analysis showed that the intervention had a larger effect in hospitals with percutaneous coronary intervention capabilities (odds ratio, 7.97) and in patients with a final diagnosis of non-STEMI (OR, 3.47), Dr. Berwanger said.

Session co-moderator Dr. Robert Harrington, director of Duke Clinical Research Institute, asked which component of the intervention really made the difference and whether a case manager who follows ACS patients throughout the hospital is sustainable.

Dr. Berwanger replied that the dedicated nurse–case manager is the key. He acknowledges that this is challenging and costly to sustain because he or she should be exempt from performing other duties, but says hospital managers and chief operating officers may become convinced and hire such staff if they start seeing the difference in quality.

At 30 days, there was a nonsignificant trend favoring the intervention hospitals over controls for major cardiovascular adverse events (5.5% vs. 7%), cardiovascular mortality (6.6% vs. 7.1%), and total mortality (7.0% vs. 8.4%).

Rates of in-hospital major bleeding events higher in the intervention group, driven largely by higher use of anticoagulants and statins, but was not significant (1.2% vs. 0.2%), Dr. Berwanger reported.

He said the investigators are continuing to follow patients at the participating hospitals as part of an observational study and are meeting with the Brazilian Health Ministry to fund a BRIDGE-ACS II trial to assess clinical outcomes of ACS.

The study was simultaneously published (JAMA 2012 [doi:10.1001/jama.2012.413]).

This study is funded by the Brazilian Ministry of Health in partnership with Hospital do Coração. Dr. Berwanger reported no competing interests.

CHICAGO – A reduced-dose regimen of tissue plasminogen activator and parenteral anticoagulant safely led to improved outcomes in hemodynamically stable patients with a pulmonary embolism in a pilot study with a total of 121 patients treated at one U.S. center.

None of the 61 patients treated with the regimen, which halved the standard dosage of tissue plasminogen activator (TPA) and cut the dosage of enoxaparin or heparin by about 20%-30%, had an intracranial hemorrhage or a major bleeding event, compared with a historic 2%-6% incidence of intracranial hemorrhage and a 6%-20% incidence of major bleeds in hemodynamically unstable pulmonary embolism patients who receive the standard, full dose of both the thrombolytic and anticoagulant, Dr. Mohsen Sharifi said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

While he acknowledged that the results need confirmation in a larger study, "in our experience treating deep vein thrombosis [with a similarly low dosage of TPA], we are comfortable that this amount of TPA can be given safely," said Dr. Sharifi, an interventional cardiologist who practices in Mesa, Ariz.

The findings also showed that applying this reduced-dose intervention to hemodynamically stable patients with a pulmonary embolism (PE), who are typically not treated, substantially improved their long-term prognosis by reducing their development of pulmonary hypertension. After an average of 28 months follow-up, 9 of the 58 patients (16%) followed long term and treated with the reduced-dose regimen had pulmonary hypertension, defined as a pulmonary artery systolic pressure greater than 40 mm Hg, compared with pulmonary hypertension in 32 of the 56 control patients (57%) managed by standard treatment with anticoagulation only.

Current guidelines from the American Heart Association call for fibrinolytic treatment only in patients with a massive, acute PE, or in patients with a submassive PE who are hemodynamically unstable or have other clinical evidence of an adverse prognosis (Circulation 2011;123:1788-830). According to Dr. Sharifi, about 5% of all PE patients fall into this category. He estimated that broadening thrombolytic treatment to hemodynamically stable patients who met his study’s inclusion criteria could broaden TPA treatment to an additional 70% of PE patients currently seen in emergency departments.

"I think that, based on the results of this pilot study, you won’t get broad acceptance of treating hemodynamically stable PE patients with thrombolysis," commented Dr. Michael Crawford, chief of general cardiology at the University of California, San Francisco. Two larger studies nearing completion are both examining the efficacy and safety of thrombolysis in patients with submassive PE.

Dr. Sharifi said that despite the small study size, he and his associates were convinced enough by their findings to use the reduced TPA dosage tested in this study on a routine basis when they see patients who meet their enrollment criteria.

The MOPETT (Moderate Pulmonary Embolism Treated with Thrombolysis) study enrolled patients with a PE affecting at least two lobar segments, pulmonary artery systolic pressure greater than 40 mm Hg; right ventricular hypokinesia and enlargement; and at least two symptoms, which could include chest pain, tachypnea greater than 22 respirations/min, tachycardia with a resting heart rate of more than 90 beats/min, dyspnea, cough, oxygen desaturation, and jugular venous pressure more than 12 mm H₂O. The average age of the patients was about 59 years, and slightly more than half were women. Their average pulmonary artery systolic pressure at entry was about 50 mm Hg.

Dr. Sharifi and his associates randomized half the patients to receive conventional treatment with anticoagulant only, either enoxaparin or heparin plus warfarin. The other patients received thrombolytic treatment with an infusion of TPA at half the standard dosage, starting in patients who weighed at least 50 kg with a loading dose of 10 mg delivered in 1 minute, and followed by a 40-mg total additional dose administered over 2 hours. Patients who weighed less received the same 10-mg initial dose, but their total dose including the subsequent 2-hour infusion was limited to 0.5 mg/kg. The patients treated with TPA also received concomitant anticoagulation, with either enoxaparin given at 1 mg/kg but not to exceed 80 mg as an initial dose, or heparin at an initial dose of 70 U/kg but capped at 6,000 U, followed by heparin maintenance at 10 U/kg per hour during the TPA infusion (but not exceeding 1,000 U/hour), and then rising to 18 U/kg per hour starting 1 hour after TPA treatment stopped. About 80% of all patients in the study received enoxaparin, and about 20% received heparin.

At 48 hours after starting treatment, average pulmonary artery systolic pressure dropped by 16 mm Hg in the TPA group and by 5 mm Hg in the control patients. By the end of the average 28-month follow-up, average pulmonary artery systolic pressure was 28 mm Hg in the TPA patients and 43 mm Hg in the controls. Dr. Sharifi attributed the efficacy of reduced-dose TPA to the "exquisite sensitivity" of blood clots lodged in a patient’s lungs to the drug, a consequence of all the infused TPA passing through the lung’s arterial circulation.

In addition to showing a statistically significant benefit from TPA for the study’s primary end point, the average duration of hospitalization in the TPA recipients was 2.2 days, compared with an average of 4.9 days in the control patients, a statistically significant difference. And at the end of the average 28 months of follow-up, three patients in the control arm had a recurrent PE and another three had died, significantly more than the no recurrent PEs and one death in the TPA arm.

Dr. Sharifi and Dr. Crawford said that they had no relevant disclosures.

CHICAGO – A reduced-dose regimen of tissue plasminogen activator and parenteral anticoagulant safely led to improved outcomes in hemodynamically stable patients with a pulmonary embolism in a pilot study with a total of 121 patients treated at one U.S. center.

None of the 61 patients treated with the regimen, which halved the standard dosage of tissue plasminogen activator (TPA) and cut the dosage of enoxaparin or heparin by about 20%-30%, had an intracranial hemorrhage or a major bleeding event, compared with a historic 2%-6% incidence of intracranial hemorrhage and a 6%-20% incidence of major bleeds in hemodynamically unstable pulmonary embolism patients who receive the standard, full dose of both the thrombolytic and anticoagulant, Dr. Mohsen Sharifi said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

While he acknowledged that the results need confirmation in a larger study, "in our experience treating deep vein thrombosis [with a similarly low dosage of TPA], we are comfortable that this amount of TPA can be given safely," said Dr. Sharifi, an interventional cardiologist who practices in Mesa, Ariz.

The findings also showed that applying this reduced-dose intervention to hemodynamically stable patients with a pulmonary embolism (PE), who are typically not treated, substantially improved their long-term prognosis by reducing their development of pulmonary hypertension. After an average of 28 months follow-up, 9 of the 58 patients (16%) followed long term and treated with the reduced-dose regimen had pulmonary hypertension, defined as a pulmonary artery systolic pressure greater than 40 mm Hg, compared with pulmonary hypertension in 32 of the 56 control patients (57%) managed by standard treatment with anticoagulation only.

Current guidelines from the American Heart Association call for fibrinolytic treatment only in patients with a massive, acute PE, or in patients with a submassive PE who are hemodynamically unstable or have other clinical evidence of an adverse prognosis (Circulation 2011;123:1788-830). According to Dr. Sharifi, about 5% of all PE patients fall into this category. He estimated that broadening thrombolytic treatment to hemodynamically stable patients who met his study’s inclusion criteria could broaden TPA treatment to an additional 70% of PE patients currently seen in emergency departments.

"I think that, based on the results of this pilot study, you won’t get broad acceptance of treating hemodynamically stable PE patients with thrombolysis," commented Dr. Michael Crawford, chief of general cardiology at the University of California, San Francisco. Two larger studies nearing completion are both examining the efficacy and safety of thrombolysis in patients with submassive PE.

Dr. Sharifi said that despite the small study size, he and his associates were convinced enough by their findings to use the reduced TPA dosage tested in this study on a routine basis when they see patients who meet their enrollment criteria.

The MOPETT (Moderate Pulmonary Embolism Treated with Thrombolysis) study enrolled patients with a PE affecting at least two lobar segments, pulmonary artery systolic pressure greater than 40 mm Hg; right ventricular hypokinesia and enlargement; and at least two symptoms, which could include chest pain, tachypnea greater than 22 respirations/min, tachycardia with a resting heart rate of more than 90 beats/min, dyspnea, cough, oxygen desaturation, and jugular venous pressure more than 12 mm H₂O. The average age of the patients was about 59 years, and slightly more than half were women. Their average pulmonary artery systolic pressure at entry was about 50 mm Hg.

Dr. Sharifi and his associates randomized half the patients to receive conventional treatment with anticoagulant only, either enoxaparin or heparin plus warfarin. The other patients received thrombolytic treatment with an infusion of TPA at half the standard dosage, starting in patients who weighed at least 50 kg with a loading dose of 10 mg delivered in 1 minute, and followed by a 40-mg total additional dose administered over 2 hours. Patients who weighed less received the same 10-mg initial dose, but their total dose including the subsequent 2-hour infusion was limited to 0.5 mg/kg. The patients treated with TPA also received concomitant anticoagulation, with either enoxaparin given at 1 mg/kg but not to exceed 80 mg as an initial dose, or heparin at an initial dose of 70 U/kg but capped at 6,000 U, followed by heparin maintenance at 10 U/kg per hour during the TPA infusion (but not exceeding 1,000 U/hour), and then rising to 18 U/kg per hour starting 1 hour after TPA treatment stopped. About 80% of all patients in the study received enoxaparin, and about 20% received heparin.

At 48 hours after starting treatment, average pulmonary artery systolic pressure dropped by 16 mm Hg in the TPA group and by 5 mm Hg in the control patients. By the end of the average 28-month follow-up, average pulmonary artery systolic pressure was 28 mm Hg in the TPA patients and 43 mm Hg in the controls. Dr. Sharifi attributed the efficacy of reduced-dose TPA to the "exquisite sensitivity" of blood clots lodged in a patient’s lungs to the drug, a consequence of all the infused TPA passing through the lung’s arterial circulation.

In addition to showing a statistically significant benefit from TPA for the study’s primary end point, the average duration of hospitalization in the TPA recipients was 2.2 days, compared with an average of 4.9 days in the control patients, a statistically significant difference. And at the end of the average 28 months of follow-up, three patients in the control arm had a recurrent PE and another three had died, significantly more than the no recurrent PEs and one death in the TPA arm.

Dr. Sharifi and Dr. Crawford said that they had no relevant disclosures.

CHICAGO – A reduced-dose regimen of tissue plasminogen activator and parenteral anticoagulant safely led to improved outcomes in hemodynamically stable patients with a pulmonary embolism in a pilot study with a total of 121 patients treated at one U.S. center.

None of the 61 patients treated with the regimen, which halved the standard dosage of tissue plasminogen activator (TPA) and cut the dosage of enoxaparin or heparin by about 20%-30%, had an intracranial hemorrhage or a major bleeding event, compared with a historic 2%-6% incidence of intracranial hemorrhage and a 6%-20% incidence of major bleeds in hemodynamically unstable pulmonary embolism patients who receive the standard, full dose of both the thrombolytic and anticoagulant, Dr. Mohsen Sharifi said at the meeting.

Mitchel L. Zoler/IMNG Medical Media

While he acknowledged that the results need confirmation in a larger study, "in our experience treating deep vein thrombosis [with a similarly low dosage of TPA], we are comfortable that this amount of TPA can be given safely," said Dr. Sharifi, an interventional cardiologist who practices in Mesa, Ariz.

The findings also showed that applying this reduced-dose intervention to hemodynamically stable patients with a pulmonary embolism (PE), who are typically not treated, substantially improved their long-term prognosis by reducing their development of pulmonary hypertension. After an average of 28 months follow-up, 9 of the 58 patients (16%) followed long term and treated with the reduced-dose regimen had pulmonary hypertension, defined as a pulmonary artery systolic pressure greater than 40 mm Hg, compared with pulmonary hypertension in 32 of the 56 control patients (57%) managed by standard treatment with anticoagulation only.

Current guidelines from the American Heart Association call for fibrinolytic treatment only in patients with a massive, acute PE, or in patients with a submassive PE who are hemodynamically unstable or have other clinical evidence of an adverse prognosis (Circulation 2011;123:1788-830). According to Dr. Sharifi, about 5% of all PE patients fall into this category. He estimated that broadening thrombolytic treatment to hemodynamically stable patients who met his study’s inclusion criteria could broaden TPA treatment to an additional 70% of PE patients currently seen in emergency departments.

"I think that, based on the results of this pilot study, you won’t get broad acceptance of treating hemodynamically stable PE patients with thrombolysis," commented Dr. Michael Crawford, chief of general cardiology at the University of California, San Francisco. Two larger studies nearing completion are both examining the efficacy and safety of thrombolysis in patients with submassive PE.

Dr. Sharifi said that despite the small study size, he and his associates were convinced enough by their findings to use the reduced TPA dosage tested in this study on a routine basis when they see patients who meet their enrollment criteria.

The MOPETT (Moderate Pulmonary Embolism Treated with Thrombolysis) study enrolled patients with a PE affecting at least two lobar segments, pulmonary artery systolic pressure greater than 40 mm Hg; right ventricular hypokinesia and enlargement; and at least two symptoms, which could include chest pain, tachypnea greater than 22 respirations/min, tachycardia with a resting heart rate of more than 90 beats/min, dyspnea, cough, oxygen desaturation, and jugular venous pressure more than 12 mm H₂O. The average age of the patients was about 59 years, and slightly more than half were women. Their average pulmonary artery systolic pressure at entry was about 50 mm Hg.

Dr. Sharifi and his associates randomized half the patients to receive conventional treatment with anticoagulant only, either enoxaparin or heparin plus warfarin. The other patients received thrombolytic treatment with an infusion of TPA at half the standard dosage, starting in patients who weighed at least 50 kg with a loading dose of 10 mg delivered in 1 minute, and followed by a 40-mg total additional dose administered over 2 hours. Patients who weighed less received the same 10-mg initial dose, but their total dose including the subsequent 2-hour infusion was limited to 0.5 mg/kg. The patients treated with TPA also received concomitant anticoagulation, with either enoxaparin given at 1 mg/kg but not to exceed 80 mg as an initial dose, or heparin at an initial dose of 70 U/kg but capped at 6,000 U, followed by heparin maintenance at 10 U/kg per hour during the TPA infusion (but not exceeding 1,000 U/hour), and then rising to 18 U/kg per hour starting 1 hour after TPA treatment stopped. About 80% of all patients in the study received enoxaparin, and about 20% received heparin.

At 48 hours after starting treatment, average pulmonary artery systolic pressure dropped by 16 mm Hg in the TPA group and by 5 mm Hg in the control patients. By the end of the average 28-month follow-up, average pulmonary artery systolic pressure was 28 mm Hg in the TPA patients and 43 mm Hg in the controls. Dr. Sharifi attributed the efficacy of reduced-dose TPA to the "exquisite sensitivity" of blood clots lodged in a patient’s lungs to the drug, a consequence of all the infused TPA passing through the lung’s arterial circulation.

In addition to showing a statistically significant benefit from TPA for the study’s primary end point, the average duration of hospitalization in the TPA recipients was 2.2 days, compared with an average of 4.9 days in the control patients, a statistically significant difference. And at the end of the average 28 months of follow-up, three patients in the control arm had a recurrent PE and another three had died, significantly more than the no recurrent PEs and one death in the TPA arm.

Dr. Sharifi and Dr. Crawford said that they had no relevant disclosures.

CHICAGO – Coronary artery bypass surgery had a significant 4-year survival advantage of 4 percentage points over percutaneous coronary intervention, based on analysis of an observational, U.S.-wide dataset with nearly 190,000 patients.

These results, from a new collaboration between the American College of Cardiology Foundation (ACCF) and the Society for Thoracic Surgeons (STS), confirmed findings made by other, recent randomized and observational studies that coronary artery bypass grafting produces a modest, long-term survival advantage in stable patients undergoing revascularization, compared with percutaneous coronary intervention. The new finding seemed notable because it came from an unprecedentedly large U.S. dataset that broadly represented U.S. practice in the mid 2000s, and because the analysis used sophisticated statistical corrections and tests to try to eliminate patient-selection factors as confounders.

ASCERT, the ACCF and STS Database Collaborative on the Comparative Effectiveness of Revascularization Strategies, "is larger than any previous study [comparing coronary artery bypass surgery and percutaneous coronary intervention], it’s contemporary data [from cases treated during 2004-2007], and it’s more generalizable because it covers the entire United States," although limited exclusively to Medicare patients who were at least 65 years old, said Dr. William S. Weintraub, lead investigator of the study, at the annual meeting of the American College of Cardiology.

But several cardiologists who heard the report cautioned that despite all the analytic efforts by Dr. Weintraub and his associates to craft a comparison that eliminated biases, the results had limited implications because the analysis had an inherent inability to provide a truly clean comparison of coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) due to its reliance on observational data.

"It’s fair to say that at least in this data set, it’s impossible to eliminate residual confounders or selection bias because of the factors that a cardiologist or surgeon integrate at the bedside, such as frailty, patient preference, bleeding risk, and compliance with medical therapy," commented Dr. Alice K. Jacobs, a cardiologist and professor of medicine at Boston University. "I think these results will probably not change clinical practice."

"You can do multivariate, propensity analyses till kingdom come, but it will never eliminate the selection biases," in these data, said Dr. Bernard J. Gersh, a cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.

"A major flaw in ASCERT was that it compared apples to oranges. It looked at a specific subset of very sick, older patients, and it did not take into account a variety of factors that could have affected these data," said Dr. Christopher J. White, president of the Society for Cardiovascular Angiography and Intervention in a written statement.

"PCI is not only a safe and effective treatment option for patients, it often is the only treatment available to patients too sick or too frail to have open heart surgery," added Dr. White, who is also professor and chairman for cardiovascular diseases at the Ochsner Heart and Vascular Institute in New Orleans.

Despite the limitations of the study, it may result in a small but meaningful resetting of how coronary revascularization is used, Dr. Weintraub said. "Practice has shifted toward PCI; this may change it back a little bit. But I don’t think it will have a tremendous effect by itself, and it probably shouldn’t," said Dr. Weintraub, chief of cardiology at Christina Care Health System in Newark, Del. "ASCERT largely supports the [coronary revascularization] guidelines that are already there," issued last year by the ACC, the American Association for Thoracic Surgery, and other organizations, he added (J. Am. Coll. Cardiol. 2011;58:2584-614; J. Am. Coll. Cardiol. 2011;58:2550-83).

"I hope we don’t have people saying that this shows that all patients should go to surgery," said cardiac surgeon Dr. Fred H. Edwards in an interview. "This is one more piece of information to use when evaluating how to treat patients with stable coronary artery disease. The information should be presented to patients and used in a dialog between surgeons and cardiologists," said Dr. Edwards, professor emeritus of surgery at the University of Florida in Jacksonville, director of the STS Research Center in Chicago, and coprincipal investigator for ASCERT.

"The key to ASCERT is its generalizability. In ASCERT we showed, hopefully definitively, that long-term survival in patients with stable two- and three-vessel coronary disease is better with surgery. But is survival the only thing that’s important? No, there is also the stroke rate, long-term quality of life, and patient preference."

The current ASCERT analysis focused on survival data for 86,244 patients who underwent CABG – data collected in the STS Adult Cardiac Surgery Database – and 103,549 patients who underwent PCI from the ACC Foundation’s National Cardiovascular Data Registry. The study’s central finding was that after adjustment by inverse probability weighing the 4-year mortality rate among CABG patients was 16.4%, and 20.8% among PCI patients. A second key finding was that initially after intervention, mortality was lower with PCI. The survival curves of the two treatment groups did not cross until 1 year out from the procedure, after which the survival advantage following CABG gradually increased over time.

Future reports will focus on other outcomes, including stroke rates, Dr. Weintraub said. Concurrent with his report at the meeting an article on the findings appeared online (N. Engl. J. Med. 2012 March 27 [doi:10.1056/NEJMoa1110717]).

Perhaps the most striking element in the findings was that the long-term survival benefit with CABG over PCI was consistent across a variety of subgroup analysis, including both women and men, and patients with or without diabetes.

"The advantage of CABG in all subgroups was a major surprise," Dr. Edwards said in an interview. "We thought that we’d see some subgroups that would benefit from PCI. Much to our surprise, all the subsets showed better survival with surgery, generally in the range of 20%-30%" on a relative basis.

Dr. Weintraub highlighted some extra analytic steps he and his associates took in the study. In addition to the primary adjusted analysis, the researchers performed a second, propensity-matched analysis on a subgroup of about 43,000 CABG patients and an equal number of PCI patients who closely matched for a list of over 20 demographic and clinical variables. The propensity-matched calculations found a similar long-term survival advantage for CABG.

They also examined whether the observed differences could be explained by an unmeasured confounder, such as frailty. To explain the observed between-group difference, "the unmeasured confounder would have to have an effect so large that it would have a hazard ratio of two, and would need to occur in about 30% of the patients in one group and in only 10% of those in the other group. How could we have missed that?" Dr. Edwards said.

Dr. Weintraub, Dr. Edwards, and Dr. White said they had no relevant disclosures. Dr. Jacobs said she had received research grants from Abiomed, Accumetrics, and Abbott Vascular. Dr. Gersh said he has been a consultant to Boston Scientific and Abbott Laboratories.

CHICAGO – Coronary artery bypass surgery had a significant 4-year survival advantage of 4 percentage points over percutaneous coronary intervention, based on analysis of an observational, U.S.-wide dataset with nearly 190,000 patients.

These results, from a new collaboration between the American College of Cardiology Foundation (ACCF) and the Society for Thoracic Surgeons (STS), confirmed findings made by other, recent randomized and observational studies that coronary artery bypass grafting produces a modest, long-term survival advantage in stable patients undergoing revascularization, compared with percutaneous coronary intervention. The new finding seemed notable because it came from an unprecedentedly large U.S. dataset that broadly represented U.S. practice in the mid 2000s, and because the analysis used sophisticated statistical corrections and tests to try to eliminate patient-selection factors as confounders.

ASCERT, the ACCF and STS Database Collaborative on the Comparative Effectiveness of Revascularization Strategies, "is larger than any previous study [comparing coronary artery bypass surgery and percutaneous coronary intervention], it’s contemporary data [from cases treated during 2004-2007], and it’s more generalizable because it covers the entire United States," although limited exclusively to Medicare patients who were at least 65 years old, said Dr. William S. Weintraub, lead investigator of the study, at the annual meeting of the American College of Cardiology.

But several cardiologists who heard the report cautioned that despite all the analytic efforts by Dr. Weintraub and his associates to craft a comparison that eliminated biases, the results had limited implications because the analysis had an inherent inability to provide a truly clean comparison of coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) due to its reliance on observational data.

"It’s fair to say that at least in this data set, it’s impossible to eliminate residual confounders or selection bias because of the factors that a cardiologist or surgeon integrate at the bedside, such as frailty, patient preference, bleeding risk, and compliance with medical therapy," commented Dr. Alice K. Jacobs, a cardiologist and professor of medicine at Boston University. "I think these results will probably not change clinical practice."

"You can do multivariate, propensity analyses till kingdom come, but it will never eliminate the selection biases," in these data, said Dr. Bernard J. Gersh, a cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.

"A major flaw in ASCERT was that it compared apples to oranges. It looked at a specific subset of very sick, older patients, and it did not take into account a variety of factors that could have affected these data," said Dr. Christopher J. White, president of the Society for Cardiovascular Angiography and Intervention in a written statement.

"PCI is not only a safe and effective treatment option for patients, it often is the only treatment available to patients too sick or too frail to have open heart surgery," added Dr. White, who is also professor and chairman for cardiovascular diseases at the Ochsner Heart and Vascular Institute in New Orleans.

Despite the limitations of the study, it may result in a small but meaningful resetting of how coronary revascularization is used, Dr. Weintraub said. "Practice has shifted toward PCI; this may change it back a little bit. But I don’t think it will have a tremendous effect by itself, and it probably shouldn’t," said Dr. Weintraub, chief of cardiology at Christina Care Health System in Newark, Del. "ASCERT largely supports the [coronary revascularization] guidelines that are already there," issued last year by the ACC, the American Association for Thoracic Surgery, and other organizations, he added (J. Am. Coll. Cardiol. 2011;58:2584-614; J. Am. Coll. Cardiol. 2011;58:2550-83).

"I hope we don’t have people saying that this shows that all patients should go to surgery," said cardiac surgeon Dr. Fred H. Edwards in an interview. "This is one more piece of information to use when evaluating how to treat patients with stable coronary artery disease. The information should be presented to patients and used in a dialog between surgeons and cardiologists," said Dr. Edwards, professor emeritus of surgery at the University of Florida in Jacksonville, director of the STS Research Center in Chicago, and coprincipal investigator for ASCERT.

"The key to ASCERT is its generalizability. In ASCERT we showed, hopefully definitively, that long-term survival in patients with stable two- and three-vessel coronary disease is better with surgery. But is survival the only thing that’s important? No, there is also the stroke rate, long-term quality of life, and patient preference."

The current ASCERT analysis focused on survival data for 86,244 patients who underwent CABG – data collected in the STS Adult Cardiac Surgery Database – and 103,549 patients who underwent PCI from the ACC Foundation’s National Cardiovascular Data Registry. The study’s central finding was that after adjustment by inverse probability weighing the 4-year mortality rate among CABG patients was 16.4%, and 20.8% among PCI patients. A second key finding was that initially after intervention, mortality was lower with PCI. The survival curves of the two treatment groups did not cross until 1 year out from the procedure, after which the survival advantage following CABG gradually increased over time.

Future reports will focus on other outcomes, including stroke rates, Dr. Weintraub said. Concurrent with his report at the meeting an article on the findings appeared online (N. Engl. J. Med. 2012 March 27 [doi:10.1056/NEJMoa1110717]).

Perhaps the most striking element in the findings was that the long-term survival benefit with CABG over PCI was consistent across a variety of subgroup analysis, including both women and men, and patients with or without diabetes.

"The advantage of CABG in all subgroups was a major surprise," Dr. Edwards said in an interview. "We thought that we’d see some subgroups that would benefit from PCI. Much to our surprise, all the subsets showed better survival with surgery, generally in the range of 20%-30%" on a relative basis.

Dr. Weintraub highlighted some extra analytic steps he and his associates took in the study. In addition to the primary adjusted analysis, the researchers performed a second, propensity-matched analysis on a subgroup of about 43,000 CABG patients and an equal number of PCI patients who closely matched for a list of over 20 demographic and clinical variables. The propensity-matched calculations found a similar long-term survival advantage for CABG.

They also examined whether the observed differences could be explained by an unmeasured confounder, such as frailty. To explain the observed between-group difference, "the unmeasured confounder would have to have an effect so large that it would have a hazard ratio of two, and would need to occur in about 30% of the patients in one group and in only 10% of those in the other group. How could we have missed that?" Dr. Edwards said.

Dr. Weintraub, Dr. Edwards, and Dr. White said they had no relevant disclosures. Dr. Jacobs said she had received research grants from Abiomed, Accumetrics, and Abbott Vascular. Dr. Gersh said he has been a consultant to Boston Scientific and Abbott Laboratories.

CHICAGO – Coronary artery bypass surgery had a significant 4-year survival advantage of 4 percentage points over percutaneous coronary intervention, based on analysis of an observational, U.S.-wide dataset with nearly 190,000 patients.

These results, from a new collaboration between the American College of Cardiology Foundation (ACCF) and the Society for Thoracic Surgeons (STS), confirmed findings made by other, recent randomized and observational studies that coronary artery bypass grafting produces a modest, long-term survival advantage in stable patients undergoing revascularization, compared with percutaneous coronary intervention. The new finding seemed notable because it came from an unprecedentedly large U.S. dataset that broadly represented U.S. practice in the mid 2000s, and because the analysis used sophisticated statistical corrections and tests to try to eliminate patient-selection factors as confounders.

ASCERT, the ACCF and STS Database Collaborative on the Comparative Effectiveness of Revascularization Strategies, "is larger than any previous study [comparing coronary artery bypass surgery and percutaneous coronary intervention], it’s contemporary data [from cases treated during 2004-2007], and it’s more generalizable because it covers the entire United States," although limited exclusively to Medicare patients who were at least 65 years old, said Dr. William S. Weintraub, lead investigator of the study, at the annual meeting of the American College of Cardiology.

But several cardiologists who heard the report cautioned that despite all the analytic efforts by Dr. Weintraub and his associates to craft a comparison that eliminated biases, the results had limited implications because the analysis had an inherent inability to provide a truly clean comparison of coronary artery bypass surgery (CABG) and percutaneous coronary intervention (PCI) due to its reliance on observational data.

"It’s fair to say that at least in this data set, it’s impossible to eliminate residual confounders or selection bias because of the factors that a cardiologist or surgeon integrate at the bedside, such as frailty, patient preference, bleeding risk, and compliance with medical therapy," commented Dr. Alice K. Jacobs, a cardiologist and professor of medicine at Boston University. "I think these results will probably not change clinical practice."

"You can do multivariate, propensity analyses till kingdom come, but it will never eliminate the selection biases," in these data, said Dr. Bernard J. Gersh, a cardiologist and professor of medicine at the Mayo Clinic in Rochester, Minn.

"A major flaw in ASCERT was that it compared apples to oranges. It looked at a specific subset of very sick, older patients, and it did not take into account a variety of factors that could have affected these data," said Dr. Christopher J. White, president of the Society for Cardiovascular Angiography and Intervention in a written statement.

"PCI is not only a safe and effective treatment option for patients, it often is the only treatment available to patients too sick or too frail to have open heart surgery," added Dr. White, who is also professor and chairman for cardiovascular diseases at the Ochsner Heart and Vascular Institute in New Orleans.

Despite the limitations of the study, it may result in a small but meaningful resetting of how coronary revascularization is used, Dr. Weintraub said. "Practice has shifted toward PCI; this may change it back a little bit. But I don’t think it will have a tremendous effect by itself, and it probably shouldn’t," said Dr. Weintraub, chief of cardiology at Christina Care Health System in Newark, Del. "ASCERT largely supports the [coronary revascularization] guidelines that are already there," issued last year by the ACC, the American Association for Thoracic Surgery, and other organizations, he added (J. Am. Coll. Cardiol. 2011;58:2584-614; J. Am. Coll. Cardiol. 2011;58:2550-83).

"I hope we don’t have people saying that this shows that all patients should go to surgery," said cardiac surgeon Dr. Fred H. Edwards in an interview. "This is one more piece of information to use when evaluating how to treat patients with stable coronary artery disease. The information should be presented to patients and used in a dialog between surgeons and cardiologists," said Dr. Edwards, professor emeritus of surgery at the University of Florida in Jacksonville, director of the STS Research Center in Chicago, and coprincipal investigator for ASCERT.

"The key to ASCERT is its generalizability. In ASCERT we showed, hopefully definitively, that long-term survival in patients with stable two- and three-vessel coronary disease is better with surgery. But is survival the only thing that’s important? No, there is also the stroke rate, long-term quality of life, and patient preference."

The current ASCERT analysis focused on survival data for 86,244 patients who underwent CABG – data collected in the STS Adult Cardiac Surgery Database – and 103,549 patients who underwent PCI from the ACC Foundation’s National Cardiovascular Data Registry. The study’s central finding was that after adjustment by inverse probability weighing the 4-year mortality rate among CABG patients was 16.4%, and 20.8% among PCI patients. A second key finding was that initially after intervention, mortality was lower with PCI. The survival curves of the two treatment groups did not cross until 1 year out from the procedure, after which the survival advantage following CABG gradually increased over time.

Future reports will focus on other outcomes, including stroke rates, Dr. Weintraub said. Concurrent with his report at the meeting an article on the findings appeared online (N. Engl. J. Med. 2012 March 27 [doi:10.1056/NEJMoa1110717]).

Perhaps the most striking element in the findings was that the long-term survival benefit with CABG over PCI was consistent across a variety of subgroup analysis, including both women and men, and patients with or without diabetes.

"The advantage of CABG in all subgroups was a major surprise," Dr. Edwards said in an interview. "We thought that we’d see some subgroups that would benefit from PCI. Much to our surprise, all the subsets showed better survival with surgery, generally in the range of 20%-30%" on a relative basis.

Dr. Weintraub highlighted some extra analytic steps he and his associates took in the study. In addition to the primary adjusted analysis, the researchers performed a second, propensity-matched analysis on a subgroup of about 43,000 CABG patients and an equal number of PCI patients who closely matched for a list of over 20 demographic and clinical variables. The propensity-matched calculations found a similar long-term survival advantage for CABG.

They also examined whether the observed differences could be explained by an unmeasured confounder, such as frailty. To explain the observed between-group difference, "the unmeasured confounder would have to have an effect so large that it would have a hazard ratio of two, and would need to occur in about 30% of the patients in one group and in only 10% of those in the other group. How could we have missed that?" Dr. Edwards said.

Dr. Weintraub, Dr. Edwards, and Dr. White said they had no relevant disclosures. Dr. Jacobs said she had received research grants from Abiomed, Accumetrics, and Abbott Vascular. Dr. Gersh said he has been a consultant to Boston Scientific and Abbott Laboratories.

CHICAGO – Triaging chest-pain patients with cardiac CT angiography increased direct emergency room discharges and shortened hospital stays, but did not reduce costs, compared with a standard emergency department evaluation, in the prospective, randomized ROMICAT-II trial.

There were no missed cases of acute coronary syndrome with either strategy in ROMICAT II, the Rule Out Myocardial Infarction using Computer Assisted Computed Tomography II trial.

Patrice Wendling/IMNG Medical Media

Incorporating cardiac computed tomography angiography (CCTA) early into an emergency department (ED) evaluation strategy improves clinical decision making for ED triage compared to current practice and is safe, principal investigator Dr. Udo Hoffmann said at the annual meeting of the American College of Cardiology.

ROMICAT II evenly randomized 1,000 patients, aged 40-74 years, with suspected acute coronary syndrome to the CCTA-based strategy or standard ED evaluation. Their mean age was 54 years and half had 2-3 major cardiovascular risk factors.

The average time to diagnosis was shortened by 8 hours with CCTA from 18.7 hours with a standard evaluation to 10.4 hours. A diagnosis could not be made in 4% of CT scans.

The average length of stay, the study’s primary end point, was significantly shorter at 23 hours vs. 31 hours with a standard evaluation. This was driven largely by patients without ACS as a final diagnosis, who averaged 17 hours in the hospital with CCTA vs. 27 hours with a standard evaluation, said Dr. Hoffmann, a cardiac radiologist at Massachusetts General Hospital in Boston.

Patients with an ACS diagnosis had similar lengths of stay, averaging 86.3 hours vs. 84 hours, respectively. ROMICAT I reported an 8% prevalence of ACS in acute chest-pain patients at low to intermediate risk of ACS.

"An interesting data point here is that it took about 8 hours to discharge 50% of patients in the CT arm, while it took about 18 hours longer to discharge 50% of patients in the standard-of-care arm," he said.

The number CCTA patients discharged directly from the emergency department was triple that of the standard-evaluation group (46.7% vs. 12.4%), with no missed ACS. At 28 days, major adverse cardiovascular events were similar, reported in two CCTA and five standard-care patients. In all, 13 CCTA patients and 19 standard-care patients returned to the ED, with seven repeat hospitalizations in both groups.

Patrice Wendling/IMNG Medical Media

Invited discussant Dr. Matthew Budoff, director of the University of California, Los Angeles BioMed CT Reading Center, observed that similar trends were just reported at the meeting from the American College of Radiology Imaging Network PA 4005 trial and were reported last year from the CT-STAT (Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment trial. (J. Am. Coll. Cardiol. 2011;58:1414-22).

"We’re now garnering significant clinical evidence with three randomized trials that are all very consistent," he said.

Financial Costs

While cost analyses are still awaited from American College of Radiology Imaging Network PA 4005, hospital billing data from a subset of patients in ROMICAT II showed that ED costs with the CCTA strategy were significantly lower, at 19% less per patient at a mean of $2,053 vs. $2,532 with a standard evaluation, Dr. Hoffmann reported. Hospital costs, however, were 50% higher with the CCTA strategy ($1,950 vs. $1,297), driven largely by significantly more diagnostic testing during the index stay and more invasive coronary angiography (12% vs. 8%).

Dr. Hoffmann said Medicare data have shown a doubling in procedures and costs after CCTA. He described the absence of an increase in costs as "a major step forward," but also acknowledged "there’s always room for improvement."

He went on to say that CCTA may become more cost effective as technology evolves and the effectiveness of CT increases and as emergency room experience with CCTA improves. ROMICAT II was conducted at centers without ED CCTA experience, and required training by Dr. Hoffmann and a coauthor was not included in the cost analysis, he acknowledged.

Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at the University of California, San Francisco Medical Center, pointed out that CCTA use in ROMICAT II was very contained since enrollment was limited to patients coming to the emergency room on weekday business hours only.

"So if you expand this to 24/7 coverage, the cost has to go up," he told reporters. "The question of what you save downstream by avoiding further tests remains to be shown in the future."

Radiation Costs

Invited discussant Dr. Elliott Antman expressed concerns about the cost of radiation exposure, noting that there was roughly a threefold increase in the cumulative radiation dose with the CCTA strategy (14.3 5.3 mSv vs. 5.3 mSv), and that chest-pain patients often present to different emergency departments.

"If in fact one adopts a strategy using cardiac CT, there is the potential for patients to have repeated exposures," said Dr. Antman, professor of medicine at Harvard University and senior faculty member in the cardiovascular division at Brigham and Women’s Hospital in Boston.

Dr. Hoffmann said there is a cost to performing a CT and to being able to discharge patients early, but also noted the collateral effect early discharge of chest-pain patients can have on getting other patients seen in the emergency room.

Dr. Budoff commented that there have been less repeat visits with CCTA in the three trials to date, and thus if one looked at cumulative radiation exposure over the subsequent year, "it might actually start to balance a little better."

This study was sponsored by Massachusetts General Hospital. Dr. Hoffmann reported research grants from the National Institutes of Health and Siemens Medical Systems. Five of his coauthors reported consulting and research funding from a variety of sources.

CHICAGO – Triaging chest-pain patients with cardiac CT angiography increased direct emergency room discharges and shortened hospital stays, but did not reduce costs, compared with a standard emergency department evaluation, in the prospective, randomized ROMICAT-II trial.

There were no missed cases of acute coronary syndrome with either strategy in ROMICAT II, the Rule Out Myocardial Infarction using Computer Assisted Computed Tomography II trial.

Patrice Wendling/IMNG Medical Media

Incorporating cardiac computed tomography angiography (CCTA) early into an emergency department (ED) evaluation strategy improves clinical decision making for ED triage compared to current practice and is safe, principal investigator Dr. Udo Hoffmann said at the annual meeting of the American College of Cardiology.

ROMICAT II evenly randomized 1,000 patients, aged 40-74 years, with suspected acute coronary syndrome to the CCTA-based strategy or standard ED evaluation. Their mean age was 54 years and half had 2-3 major cardiovascular risk factors.

The average time to diagnosis was shortened by 8 hours with CCTA from 18.7 hours with a standard evaluation to 10.4 hours. A diagnosis could not be made in 4% of CT scans.

The average length of stay, the study’s primary end point, was significantly shorter at 23 hours vs. 31 hours with a standard evaluation. This was driven largely by patients without ACS as a final diagnosis, who averaged 17 hours in the hospital with CCTA vs. 27 hours with a standard evaluation, said Dr. Hoffmann, a cardiac radiologist at Massachusetts General Hospital in Boston.

Patients with an ACS diagnosis had similar lengths of stay, averaging 86.3 hours vs. 84 hours, respectively. ROMICAT I reported an 8% prevalence of ACS in acute chest-pain patients at low to intermediate risk of ACS.

"An interesting data point here is that it took about 8 hours to discharge 50% of patients in the CT arm, while it took about 18 hours longer to discharge 50% of patients in the standard-of-care arm," he said.

The number CCTA patients discharged directly from the emergency department was triple that of the standard-evaluation group (46.7% vs. 12.4%), with no missed ACS. At 28 days, major adverse cardiovascular events were similar, reported in two CCTA and five standard-care patients. In all, 13 CCTA patients and 19 standard-care patients returned to the ED, with seven repeat hospitalizations in both groups.

Patrice Wendling/IMNG Medical Media

Invited discussant Dr. Matthew Budoff, director of the University of California, Los Angeles BioMed CT Reading Center, observed that similar trends were just reported at the meeting from the American College of Radiology Imaging Network PA 4005 trial and were reported last year from the CT-STAT (Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment trial. (J. Am. Coll. Cardiol. 2011;58:1414-22).

"We’re now garnering significant clinical evidence with three randomized trials that are all very consistent," he said.

Financial Costs

While cost analyses are still awaited from American College of Radiology Imaging Network PA 4005, hospital billing data from a subset of patients in ROMICAT II showed that ED costs with the CCTA strategy were significantly lower, at 19% less per patient at a mean of $2,053 vs. $2,532 with a standard evaluation, Dr. Hoffmann reported. Hospital costs, however, were 50% higher with the CCTA strategy ($1,950 vs. $1,297), driven largely by significantly more diagnostic testing during the index stay and more invasive coronary angiography (12% vs. 8%).

Dr. Hoffmann said Medicare data have shown a doubling in procedures and costs after CCTA. He described the absence of an increase in costs as "a major step forward," but also acknowledged "there’s always room for improvement."

He went on to say that CCTA may become more cost effective as technology evolves and the effectiveness of CT increases and as emergency room experience with CCTA improves. ROMICAT II was conducted at centers without ED CCTA experience, and required training by Dr. Hoffmann and a coauthor was not included in the cost analysis, he acknowledged.

Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at the University of California, San Francisco Medical Center, pointed out that CCTA use in ROMICAT II was very contained since enrollment was limited to patients coming to the emergency room on weekday business hours only.

"So if you expand this to 24/7 coverage, the cost has to go up," he told reporters. "The question of what you save downstream by avoiding further tests remains to be shown in the future."

Radiation Costs

Invited discussant Dr. Elliott Antman expressed concerns about the cost of radiation exposure, noting that there was roughly a threefold increase in the cumulative radiation dose with the CCTA strategy (14.3 5.3 mSv vs. 5.3 mSv), and that chest-pain patients often present to different emergency departments.

"If in fact one adopts a strategy using cardiac CT, there is the potential for patients to have repeated exposures," said Dr. Antman, professor of medicine at Harvard University and senior faculty member in the cardiovascular division at Brigham and Women’s Hospital in Boston.

Dr. Hoffmann said there is a cost to performing a CT and to being able to discharge patients early, but also noted the collateral effect early discharge of chest-pain patients can have on getting other patients seen in the emergency room.

Dr. Budoff commented that there have been less repeat visits with CCTA in the three trials to date, and thus if one looked at cumulative radiation exposure over the subsequent year, "it might actually start to balance a little better."

This study was sponsored by Massachusetts General Hospital. Dr. Hoffmann reported research grants from the National Institutes of Health and Siemens Medical Systems. Five of his coauthors reported consulting and research funding from a variety of sources.

CHICAGO – Triaging chest-pain patients with cardiac CT angiography increased direct emergency room discharges and shortened hospital stays, but did not reduce costs, compared with a standard emergency department evaluation, in the prospective, randomized ROMICAT-II trial.

There were no missed cases of acute coronary syndrome with either strategy in ROMICAT II, the Rule Out Myocardial Infarction using Computer Assisted Computed Tomography II trial.

Patrice Wendling/IMNG Medical Media

Incorporating cardiac computed tomography angiography (CCTA) early into an emergency department (ED) evaluation strategy improves clinical decision making for ED triage compared to current practice and is safe, principal investigator Dr. Udo Hoffmann said at the annual meeting of the American College of Cardiology.

ROMICAT II evenly randomized 1,000 patients, aged 40-74 years, with suspected acute coronary syndrome to the CCTA-based strategy or standard ED evaluation. Their mean age was 54 years and half had 2-3 major cardiovascular risk factors.

The average time to diagnosis was shortened by 8 hours with CCTA from 18.7 hours with a standard evaluation to 10.4 hours. A diagnosis could not be made in 4% of CT scans.

The average length of stay, the study’s primary end point, was significantly shorter at 23 hours vs. 31 hours with a standard evaluation. This was driven largely by patients without ACS as a final diagnosis, who averaged 17 hours in the hospital with CCTA vs. 27 hours with a standard evaluation, said Dr. Hoffmann, a cardiac radiologist at Massachusetts General Hospital in Boston.

Patients with an ACS diagnosis had similar lengths of stay, averaging 86.3 hours vs. 84 hours, respectively. ROMICAT I reported an 8% prevalence of ACS in acute chest-pain patients at low to intermediate risk of ACS.

"An interesting data point here is that it took about 8 hours to discharge 50% of patients in the CT arm, while it took about 18 hours longer to discharge 50% of patients in the standard-of-care arm," he said.

The number CCTA patients discharged directly from the emergency department was triple that of the standard-evaluation group (46.7% vs. 12.4%), with no missed ACS. At 28 days, major adverse cardiovascular events were similar, reported in two CCTA and five standard-care patients. In all, 13 CCTA patients and 19 standard-care patients returned to the ED, with seven repeat hospitalizations in both groups.

Patrice Wendling/IMNG Medical Media

Invited discussant Dr. Matthew Budoff, director of the University of California, Los Angeles BioMed CT Reading Center, observed that similar trends were just reported at the meeting from the American College of Radiology Imaging Network PA 4005 trial and were reported last year from the CT-STAT (Computed Tomography for Systematic Triage of Acute Chest Pain Patients to Treatment trial. (J. Am. Coll. Cardiol. 2011;58:1414-22).

"We’re now garnering significant clinical evidence with three randomized trials that are all very consistent," he said.

Financial Costs

While cost analyses are still awaited from American College of Radiology Imaging Network PA 4005, hospital billing data from a subset of patients in ROMICAT II showed that ED costs with the CCTA strategy were significantly lower, at 19% less per patient at a mean of $2,053 vs. $2,532 with a standard evaluation, Dr. Hoffmann reported. Hospital costs, however, were 50% higher with the CCTA strategy ($1,950 vs. $1,297), driven largely by significantly more diagnostic testing during the index stay and more invasive coronary angiography (12% vs. 8%).

Dr. Hoffmann said Medicare data have shown a doubling in procedures and costs after CCTA. He described the absence of an increase in costs as "a major step forward," but also acknowledged "there’s always room for improvement."

He went on to say that CCTA may become more cost effective as technology evolves and the effectiveness of CT increases and as emergency room experience with CCTA improves. ROMICAT II was conducted at centers without ED CCTA experience, and required training by Dr. Hoffmann and a coauthor was not included in the cost analysis, he acknowledged.

Dr. Michael Crawford, professor of medicine and chief of clinical cardiology at the University of California, San Francisco Medical Center, pointed out that CCTA use in ROMICAT II was very contained since enrollment was limited to patients coming to the emergency room on weekday business hours only.

"So if you expand this to 24/7 coverage, the cost has to go up," he told reporters. "The question of what you save downstream by avoiding further tests remains to be shown in the future."

Radiation Costs

Invited discussant Dr. Elliott Antman expressed concerns about the cost of radiation exposure, noting that there was roughly a threefold increase in the cumulative radiation dose with the CCTA strategy (14.3 5.3 mSv vs. 5.3 mSv), and that chest-pain patients often present to different emergency departments.

"If in fact one adopts a strategy using cardiac CT, there is the potential for patients to have repeated exposures," said Dr. Antman, professor of medicine at Harvard University and senior faculty member in the cardiovascular division at Brigham and Women’s Hospital in Boston.

Dr. Hoffmann said there is a cost to performing a CT and to being able to discharge patients early, but also noted the collateral effect early discharge of chest-pain patients can have on getting other patients seen in the emergency room.

Dr. Budoff commented that there have been less repeat visits with CCTA in the three trials to date, and thus if one looked at cumulative radiation exposure over the subsequent year, "it might actually start to balance a little better."

This study was sponsored by Massachusetts General Hospital. Dr. Hoffmann reported research grants from the National Institutes of Health and Siemens Medical Systems. Five of his coauthors reported consulting and research funding from a variety of sources.

CHICAGO – Glucose, insulin, and potassium given in the field to patients with suspected acute coronary syndrome cut in half the odds of pre- or in-hospital cardiac arrest or death in the prospective, double-blind, randomized IMMEDIATE trial.

The benefits of glucose, insulin, and potassium (GIK) were even more pronounced in patients with ST-elevation myocardial infarction (STEMI), reducing this outcome by a statistically significant 60%, compared with placebo (6% vs. 14%; risk ratio, 0.39).

The study’s primary end point of progression to myocardial infarction at 30 days was reported in 49% of GIK and 53% of placebo patients, a nonsignificant difference.

Although GIK did not prevent infarcts, it significantly reduced their size, coprincipal investigator Dr. Harry P. Selker said at the annual meeting of the American College of Cardiology.

"Risks and side effects rates from GIK are very low and GIK is inexpensive, potentially available in all communities, and deserves further evaluation in trials for widespread," he said.

Despite missing its primary end point, the panel of invited discussants was enthusiastic about the potential for IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care) to revive the 50-year-old therapy, long advocated by the late Tufts researcher Dr. Carl Apstein.

Panelist Dr. Bernard Gersh, from the Mayo Clinic in Rochester, Minn., asked whether the investigators were surprised at the magnitude of the treatment effect, given that GIK has failed in prior trials involving more than 20,000 patients.

"No, first of all, we know that most of the mortality is in that first hour since cardiac arrest and a lot of its effect is [against] cardiac arrest," replied Dr. Selker, professor of medicine and director of the Center for Cardiovascular Health Services Research at Tufts Medical Center in Boston. Experimental animal studies have also shown a 50% reduction in cardiac arrest. GIK decreases plasma and cellular free fatty acid levels, which are known to damage cell membranes and cause arrhythmias, supports the myocardium when there is less blood flow, and preserves myocardial potassium, an antiarrhythmic.

Notably, a subgroup analysis confirmed a significant benefit for GIK on cardiac arrest or hospital mortality only in those patients who received the therapy within 1 hour of symptom onset (odds ratio, 0.28), compared with those receiving GIK at least 1-6 hours (OR, 0.39) or more than 6 hours after symptom onset (OR, 1.18).

Dr. Elliott Antman, professor of medicine at Harvard University and senior faculty member in the cardiovascular division at Brigham and Women’s Hospital in Boston, asked why IMMEDIATE succeeded where so many other earlier GIK trials failed.

GIK was used for 12 hours, not 24-48 hours as previously done in other trials, said Dr. Selker, who also remarked that larger trials are needed to validate the findings since there are opposing data.

IMMEDIATE randomized 911 patients with suspected acute coronary syndrome to usual care or 30% glucose plus 50 IU insulin and 80 mEq potassium chloride/L at 1.5 mL/kg per hour administered en route by paramedics. All patients had a 12-lead ambulance ECG with Acute Ca Ischemia–Time-Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) decision support.

Patients had at least one of the following: at least 75% predicted probability of ACS on ACI-TIPI, TPI detection of STEMI, or STEMI identified by local EMS protocol. Their mean age was 63 years and one-third had a history of myocardial infarction. Paramedics were from 36 EMS systems in 13 states across the country.

Pre- or in-hospital cardiac arrest or mortality was reported in 4% of GIK vs. 9% of placebo patients, a significant difference. The individual components of the composite outcome trended in the right direction, but did not achieve significance, Dr. Selker said.

At 30 days, 4% of the 432 GIK patients and 6% of the 479 placebo patients had died, a nonsignificant difference.

Mortality or hospitalization for heart failure was also similar between groups, occurring in 6% of GIK and 8% of placebo patients at 30 days.

Among STEMI patients, only the composite of cardiac arrest or pre- or in-hospital mortality significantly favored the GIK arm.

The percentage of patients with any glucose greater than 300 mg/dL was significantly higher in the GIK arm at 21% vs. 10% in the placebo arm. GIK also raised glucose levels in patients with diabetes (44% vs. 29%), but this did not lead to any serious adverse events, Dr. Selker said.

Dr. Antman asked whether the investigators evaluated the location of the STEMI because of the potential for an imbalance in anterior versus inferior locations that might have favored the GIK group. Dr. Selker said they had not performed that subanalysis.

IMMEDIATE was simultaneously published in JAMA (JAMA 2012 March 27 [doi: 10.1001/jama.2012.426]).

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Selker and his coauthors reported no relevant conflicts of interest.

CHICAGO – Glucose, insulin, and potassium given in the field to patients with suspected acute coronary syndrome cut in half the odds of pre- or in-hospital cardiac arrest or death in the prospective, double-blind, randomized IMMEDIATE trial.

The benefits of glucose, insulin, and potassium (GIK) were even more pronounced in patients with ST-elevation myocardial infarction (STEMI), reducing this outcome by a statistically significant 60%, compared with placebo (6% vs. 14%; risk ratio, 0.39).

The study’s primary end point of progression to myocardial infarction at 30 days was reported in 49% of GIK and 53% of placebo patients, a nonsignificant difference.

Although GIK did not prevent infarcts, it significantly reduced their size, coprincipal investigator Dr. Harry P. Selker said at the annual meeting of the American College of Cardiology.

"Risks and side effects rates from GIK are very low and GIK is inexpensive, potentially available in all communities, and deserves further evaluation in trials for widespread," he said.

Despite missing its primary end point, the panel of invited discussants was enthusiastic about the potential for IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care) to revive the 50-year-old therapy, long advocated by the late Tufts researcher Dr. Carl Apstein.

Panelist Dr. Bernard Gersh, from the Mayo Clinic in Rochester, Minn., asked whether the investigators were surprised at the magnitude of the treatment effect, given that GIK has failed in prior trials involving more than 20,000 patients.

"No, first of all, we know that most of the mortality is in that first hour since cardiac arrest and a lot of its effect is [against] cardiac arrest," replied Dr. Selker, professor of medicine and director of the Center for Cardiovascular Health Services Research at Tufts Medical Center in Boston. Experimental animal studies have also shown a 50% reduction in cardiac arrest. GIK decreases plasma and cellular free fatty acid levels, which are known to damage cell membranes and cause arrhythmias, supports the myocardium when there is less blood flow, and preserves myocardial potassium, an antiarrhythmic.

Notably, a subgroup analysis confirmed a significant benefit for GIK on cardiac arrest or hospital mortality only in those patients who received the therapy within 1 hour of symptom onset (odds ratio, 0.28), compared with those receiving GIK at least 1-6 hours (OR, 0.39) or more than 6 hours after symptom onset (OR, 1.18).

Dr. Elliott Antman, professor of medicine at Harvard University and senior faculty member in the cardiovascular division at Brigham and Women’s Hospital in Boston, asked why IMMEDIATE succeeded where so many other earlier GIK trials failed.

GIK was used for 12 hours, not 24-48 hours as previously done in other trials, said Dr. Selker, who also remarked that larger trials are needed to validate the findings since there are opposing data.

IMMEDIATE randomized 911 patients with suspected acute coronary syndrome to usual care or 30% glucose plus 50 IU insulin and 80 mEq potassium chloride/L at 1.5 mL/kg per hour administered en route by paramedics. All patients had a 12-lead ambulance ECG with Acute Ca Ischemia–Time-Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) decision support.

Patients had at least one of the following: at least 75% predicted probability of ACS on ACI-TIPI, TPI detection of STEMI, or STEMI identified by local EMS protocol. Their mean age was 63 years and one-third had a history of myocardial infarction. Paramedics were from 36 EMS systems in 13 states across the country.

Pre- or in-hospital cardiac arrest or mortality was reported in 4% of GIK vs. 9% of placebo patients, a significant difference. The individual components of the composite outcome trended in the right direction, but did not achieve significance, Dr. Selker said.

At 30 days, 4% of the 432 GIK patients and 6% of the 479 placebo patients had died, a nonsignificant difference.

Mortality or hospitalization for heart failure was also similar between groups, occurring in 6% of GIK and 8% of placebo patients at 30 days.

Among STEMI patients, only the composite of cardiac arrest or pre- or in-hospital mortality significantly favored the GIK arm.

The percentage of patients with any glucose greater than 300 mg/dL was significantly higher in the GIK arm at 21% vs. 10% in the placebo arm. GIK also raised glucose levels in patients with diabetes (44% vs. 29%), but this did not lead to any serious adverse events, Dr. Selker said.

Dr. Antman asked whether the investigators evaluated the location of the STEMI because of the potential for an imbalance in anterior versus inferior locations that might have favored the GIK group. Dr. Selker said they had not performed that subanalysis.

IMMEDIATE was simultaneously published in JAMA (JAMA 2012 March 27 [doi: 10.1001/jama.2012.426]).

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Selker and his coauthors reported no relevant conflicts of interest.

CHICAGO – Glucose, insulin, and potassium given in the field to patients with suspected acute coronary syndrome cut in half the odds of pre- or in-hospital cardiac arrest or death in the prospective, double-blind, randomized IMMEDIATE trial.

The benefits of glucose, insulin, and potassium (GIK) were even more pronounced in patients with ST-elevation myocardial infarction (STEMI), reducing this outcome by a statistically significant 60%, compared with placebo (6% vs. 14%; risk ratio, 0.39).

The study’s primary end point of progression to myocardial infarction at 30 days was reported in 49% of GIK and 53% of placebo patients, a nonsignificant difference.

Although GIK did not prevent infarcts, it significantly reduced their size, coprincipal investigator Dr. Harry P. Selker said at the annual meeting of the American College of Cardiology.

"Risks and side effects rates from GIK are very low and GIK is inexpensive, potentially available in all communities, and deserves further evaluation in trials for widespread," he said.

Despite missing its primary end point, the panel of invited discussants was enthusiastic about the potential for IMMEDIATE (Immediate Myocardial Metabolic Enhancement During Initial Assessment and Treatment in Emergency Care) to revive the 50-year-old therapy, long advocated by the late Tufts researcher Dr. Carl Apstein.

Panelist Dr. Bernard Gersh, from the Mayo Clinic in Rochester, Minn., asked whether the investigators were surprised at the magnitude of the treatment effect, given that GIK has failed in prior trials involving more than 20,000 patients.

"No, first of all, we know that most of the mortality is in that first hour since cardiac arrest and a lot of its effect is [against] cardiac arrest," replied Dr. Selker, professor of medicine and director of the Center for Cardiovascular Health Services Research at Tufts Medical Center in Boston. Experimental animal studies have also shown a 50% reduction in cardiac arrest. GIK decreases plasma and cellular free fatty acid levels, which are known to damage cell membranes and cause arrhythmias, supports the myocardium when there is less blood flow, and preserves myocardial potassium, an antiarrhythmic.

Notably, a subgroup analysis confirmed a significant benefit for GIK on cardiac arrest or hospital mortality only in those patients who received the therapy within 1 hour of symptom onset (odds ratio, 0.28), compared with those receiving GIK at least 1-6 hours (OR, 0.39) or more than 6 hours after symptom onset (OR, 1.18).

Dr. Elliott Antman, professor of medicine at Harvard University and senior faculty member in the cardiovascular division at Brigham and Women’s Hospital in Boston, asked why IMMEDIATE succeeded where so many other earlier GIK trials failed.

GIK was used for 12 hours, not 24-48 hours as previously done in other trials, said Dr. Selker, who also remarked that larger trials are needed to validate the findings since there are opposing data.

IMMEDIATE randomized 911 patients with suspected acute coronary syndrome to usual care or 30% glucose plus 50 IU insulin and 80 mEq potassium chloride/L at 1.5 mL/kg per hour administered en route by paramedics. All patients had a 12-lead ambulance ECG with Acute Ca Ischemia–Time-Insensitive Predictive Instrument (ACI-TIPI) and Thrombolytic Predictive Instrument (TPI) decision support.

Patients had at least one of the following: at least 75% predicted probability of ACS on ACI-TIPI, TPI detection of STEMI, or STEMI identified by local EMS protocol. Their mean age was 63 years and one-third had a history of myocardial infarction. Paramedics were from 36 EMS systems in 13 states across the country.

Pre- or in-hospital cardiac arrest or mortality was reported in 4% of GIK vs. 9% of placebo patients, a significant difference. The individual components of the composite outcome trended in the right direction, but did not achieve significance, Dr. Selker said.

At 30 days, 4% of the 432 GIK patients and 6% of the 479 placebo patients had died, a nonsignificant difference.

Mortality or hospitalization for heart failure was also similar between groups, occurring in 6% of GIK and 8% of placebo patients at 30 days.

Among STEMI patients, only the composite of cardiac arrest or pre- or in-hospital mortality significantly favored the GIK arm.

The percentage of patients with any glucose greater than 300 mg/dL was significantly higher in the GIK arm at 21% vs. 10% in the placebo arm. GIK also raised glucose levels in patients with diabetes (44% vs. 29%), but this did not lead to any serious adverse events, Dr. Selker said.

Dr. Antman asked whether the investigators evaluated the location of the STEMI because of the potential for an imbalance in anterior versus inferior locations that might have favored the GIK group. Dr. Selker said they had not performed that subanalysis.

IMMEDIATE was simultaneously published in JAMA (JAMA 2012 March 27 [doi: 10.1001/jama.2012.426]).

This study was funded by the National Heart, Lung, and Blood Institute. Dr. Selker and his coauthors reported no relevant conflicts of interest.

CHICAGO – Cardiac CT angiography in the emergency department safely redirects to home the many patients who would otherwise be admitted for acute chest pain, according to results of the prospective, randomized ACRIN PA 4005 trial.

Low- to intermediate-risk patients who receive cardiac computed tomographic angiography (CCTA) were more likely to be discharged directly from the emergency department (ED), to have shorter hospital stays, and to have more than double the coronary artery disease (CAD) diagnosed than were those receiving a traditional evaluation.

Moreover, none of the 640 patients who had a negative CCTA died or had a myocardial infarction within 30 days after presentation (95% confidence interval, 0-0.57), Dr. Harold Litt, principal investigator of ACRIN (American College of Radiology Imaging Network) PA 4005, said at the annual meeting of the American College of Cardiology.

The upper limit of the confidence interval met the study’s prespecified safety threshold of less than 1%, and may be robust enough to help sway ED physicians who have been unwilling to adopt a CT-based strategy because similar findings from other randomized trials were not sufficiently powered.

"This is a large public health problem," Dr. Litt said, noting that roughly 2%-3% of patients are discharged from the ED with an unrecognized MI.

Conversely, more than 6 million Americans visit the ED for chest pain each year. Only 10%-15% are ultimately diagnosed with acute coronary syndrome (ACS), with most admitted to hospitals at a staggering cost of more than $3 billion annually.

The ACRIN PA 4005 trial randomized 1,370 patients with symptoms consistent with possible ACS from five clinical sites to undergo at least 64-slice CCTA or traditional evaluation, comprising mostly – but not limited to – exercise treadmill test, stress test with imaging, and stress echocardiography. They had an average TIMI (Thrombolysis in Myocardial Infarction) risk score of 0-2 and an electrocardiogram without acute ischemia. Their average age was about 50 years, and 60% were black.

Half of the 908 CCTA patients were discharged directly from the ED, compared with 23% of the 642 traditional-care patients (95% CI, 21.4-32.2).

The overall length of stay was 18 hours and 25 hours, respectively, but decreased even further to 12 hours for the 602 CCTA patients who had a negative scan, said Dr. Litt, chief of cardiovascular imaging at the University of Pennsylvania Health System in Philadelphia.

The CCTA group was also less likely than was the traditional-care group to have negative findings on invasive angiography (29% vs. 53%; 95% CI, –48.8-3.3).

The finding of more incidental CAD diagnoses in the CCTA arm vs. the traditional-care arm (9% vs. 3.5%; 95% CI, 0-11.2) is more problematic to interpret.

"Will this result in better prevention for them as they go on?" he asked. "Will they be encouraged to have lifestyle modifications and be put on statins, etc., resulting in lower future event rates and not showing up in the emergency room? Or will it just result in more testing that won’t be a benefit to them? We don’t know the answer to that."

No significant differences were observed in a 30-day resource utilization that included catheterization, revascularization, repeat ED visit, rehospitalization, and cardiologist visit. A 1-year follow-up is being obtained, and cost modeling will be conducted, he said. The possibility for substantial health care savings exists, however, as low- to intermediate-risk patients account for 50%-70% of cases presenting with possible ACS.

Overall, MI was reported within 30 days after presentation in 10 CCTA patientsand 5 traditional-care patients (1% vs. 11%; CI, –5.6-5.7). One serious adverse event (bradyarrhythmia) occurred in each group. There were no cardiac deaths in the traditional-care group.

Dr. Litt acknowledged that CCTA does increase radiation exposure, but said that radiation dosage is very technology dependent and that current technology has reduced the average radiation dose to less than that from nuclear myocardial perfusion studies. He also cautioned that the ACRIN PA 4005 results should not be extrapolated to groups with a higher risk of clinically significant coronary disease.

Invited discussant Dr. Thomas Gerber, a professor of medicine and radiology at Mayo Clinic in Jacksonville, Fla., asked why the investigators chose to focus on coronary CT angiography instead of the "triple rule-out" CT angiography strategy to evaluate the coronary arteries, pulmonary arteries, and thoracic aorta, and whether there were any patients who had pulmonary embolism or aortic dissection on subsequent evaluation.

Dr. Litt said they did track PE and acute aortic syndromes, and will report these findings in the future. The investigators used CCTA because they wanted to focus on patients in whom exclusion of ACS was the primary diagnostic question. He acknowledged that not all dissections are visible on CT, but added that "we are getting to the point where the radiology dose from a triple rule-out isn’t all that much higher than from a coronary CT. So in light of that new technology, that question may need to be reevaluated."

In a separate interview, Dr. James G. Adams, professor and chair of emergency medicine at Northwestern University in Chicago, said that no test is perfect, that all the evidence shows that coronary CT is at least as good as other testing strategies used in the initial evaluation of patients with acute chest pain, and that there are fewer hospital admissions.

"This [study] will certainly be used to promote coronary CT for patients at low to moderate risk of coronary disease," he said. "I believe that emergency physicians will increase their use."

Adoption of the CCTA approach depends on much more than whether emergency physicians find the results convincing, emergency physician Dr. Robert Solomon of Allegheny General Hospital in Pittsburgh said in an interview.

"Cardiology and radiology must also buy into it, and the resources necessary to enable clinicians to use this approach must be made available," he said. "This includes cardiologists, radiologists, and trained technologists. The necessary resources will not be available 24-7, even at tertiary care centers, so timing will always be an issue."

This study was sponsored by the Commonwealth of Pennsylvania Department of Health and the American Radiology Imaging Network Foundation. Dr. Litt reported grant funding and travel reimbursement from Siemens Medical Solutions and consulting fees from Medrad-Bayer. The study was simultaneously published online in the New England Journal of Medicine (2012 March 26 [doi:10.1056/NEJMoa1201163]).

CHICAGO – Cardiac CT angiography in the emergency department safely redirects to home the many patients who would otherwise be admitted for acute chest pain, according to results of the prospective, randomized ACRIN PA 4005 trial.

Low- to intermediate-risk patients who receive cardiac computed tomographic angiography (CCTA) were more likely to be discharged directly from the emergency department (ED), to have shorter hospital stays, and to have more than double the coronary artery disease (CAD) diagnosed than were those receiving a traditional evaluation.

Moreover, none of the 640 patients who had a negative CCTA died or had a myocardial infarction within 30 days after presentation (95% confidence interval, 0-0.57), Dr. Harold Litt, principal investigator of ACRIN (American College of Radiology Imaging Network) PA 4005, said at the annual meeting of the American College of Cardiology.

The upper limit of the confidence interval met the study’s prespecified safety threshold of less than 1%, and may be robust enough to help sway ED physicians who have been unwilling to adopt a CT-based strategy because similar findings from other randomized trials were not sufficiently powered.

"This is a large public health problem," Dr. Litt said, noting that roughly 2%-3% of patients are discharged from the ED with an unrecognized MI.

Conversely, more than 6 million Americans visit the ED for chest pain each year. Only 10%-15% are ultimately diagnosed with acute coronary syndrome (ACS), with most admitted to hospitals at a staggering cost of more than $3 billion annually.

The ACRIN PA 4005 trial randomized 1,370 patients with symptoms consistent with possible ACS from five clinical sites to undergo at least 64-slice CCTA or traditional evaluation, comprising mostly – but not limited to – exercise treadmill test, stress test with imaging, and stress echocardiography. They had an average TIMI (Thrombolysis in Myocardial Infarction) risk score of 0-2 and an electrocardiogram without acute ischemia. Their average age was about 50 years, and 60% were black.

Half of the 908 CCTA patients were discharged directly from the ED, compared with 23% of the 642 traditional-care patients (95% CI, 21.4-32.2).

The overall length of stay was 18 hours and 25 hours, respectively, but decreased even further to 12 hours for the 602 CCTA patients who had a negative scan, said Dr. Litt, chief of cardiovascular imaging at the University of Pennsylvania Health System in Philadelphia.

The CCTA group was also less likely than was the traditional-care group to have negative findings on invasive angiography (29% vs. 53%; 95% CI, –48.8-3.3).

The finding of more incidental CAD diagnoses in the CCTA arm vs. the traditional-care arm (9% vs. 3.5%; 95% CI, 0-11.2) is more problematic to interpret.

"Will this result in better prevention for them as they go on?" he asked. "Will they be encouraged to have lifestyle modifications and be put on statins, etc., resulting in lower future event rates and not showing up in the emergency room? Or will it just result in more testing that won’t be a benefit to them? We don’t know the answer to that."

No significant differences were observed in a 30-day resource utilization that included catheterization, revascularization, repeat ED visit, rehospitalization, and cardiologist visit. A 1-year follow-up is being obtained, and cost modeling will be conducted, he said. The possibility for substantial health care savings exists, however, as low- to intermediate-risk patients account for 50%-70% of cases presenting with possible ACS.

Overall, MI was reported within 30 days after presentation in 10 CCTA patientsand 5 traditional-care patients (1% vs. 11%; CI, –5.6-5.7). One serious adverse event (bradyarrhythmia) occurred in each group. There were no cardiac deaths in the traditional-care group.

Dr. Litt acknowledged that CCTA does increase radiation exposure, but said that radiation dosage is very technology dependent and that current technology has reduced the average radiation dose to less than that from nuclear myocardial perfusion studies. He also cautioned that the ACRIN PA 4005 results should not be extrapolated to groups with a higher risk of clinically significant coronary disease.

Invited discussant Dr. Thomas Gerber, a professor of medicine and radiology at Mayo Clinic in Jacksonville, Fla., asked why the investigators chose to focus on coronary CT angiography instead of the "triple rule-out" CT angiography strategy to evaluate the coronary arteries, pulmonary arteries, and thoracic aorta, and whether there were any patients who had pulmonary embolism or aortic dissection on subsequent evaluation.

Dr. Litt said they did track PE and acute aortic syndromes, and will report these findings in the future. The investigators used CCTA because they wanted to focus on patients in whom exclusion of ACS was the primary diagnostic question. He acknowledged that not all dissections are visible on CT, but added that "we are getting to the point where the radiology dose from a triple rule-out isn’t all that much higher than from a coronary CT. So in light of that new technology, that question may need to be reevaluated."

In a separate interview, Dr. James G. Adams, professor and chair of emergency medicine at Northwestern University in Chicago, said that no test is perfect, that all the evidence shows that coronary CT is at least as good as other testing strategies used in the initial evaluation of patients with acute chest pain, and that there are fewer hospital admissions.

"This [study] will certainly be used to promote coronary CT for patients at low to moderate risk of coronary disease," he said. "I believe that emergency physicians will increase their use."

Adoption of the CCTA approach depends on much more than whether emergency physicians find the results convincing, emergency physician Dr. Robert Solomon of Allegheny General Hospital in Pittsburgh said in an interview.

"Cardiology and radiology must also buy into it, and the resources necessary to enable clinicians to use this approach must be made available," he said. "This includes cardiologists, radiologists, and trained technologists. The necessary resources will not be available 24-7, even at tertiary care centers, so timing will always be an issue."

This study was sponsored by the Commonwealth of Pennsylvania Department of Health and the American Radiology Imaging Network Foundation. Dr. Litt reported grant funding and travel reimbursement from Siemens Medical Solutions and consulting fees from Medrad-Bayer. The study was simultaneously published online in the New England Journal of Medicine (2012 March 26 [doi:10.1056/NEJMoa1201163]).

CHICAGO – Cardiac CT angiography in the emergency department safely redirects to home the many patients who would otherwise be admitted for acute chest pain, according to results of the prospective, randomized ACRIN PA 4005 trial.

Low- to intermediate-risk patients who receive cardiac computed tomographic angiography (CCTA) were more likely to be discharged directly from the emergency department (ED), to have shorter hospital stays, and to have more than double the coronary artery disease (CAD) diagnosed than were those receiving a traditional evaluation.

Moreover, none of the 640 patients who had a negative CCTA died or had a myocardial infarction within 30 days after presentation (95% confidence interval, 0-0.57), Dr. Harold Litt, principal investigator of ACRIN (American College of Radiology Imaging Network) PA 4005, said at the annual meeting of the American College of Cardiology.

The upper limit of the confidence interval met the study’s prespecified safety threshold of less than 1%, and may be robust enough to help sway ED physicians who have been unwilling to adopt a CT-based strategy because similar findings from other randomized trials were not sufficiently powered.

"This is a large public health problem," Dr. Litt said, noting that roughly 2%-3% of patients are discharged from the ED with an unrecognized MI.

Conversely, more than 6 million Americans visit the ED for chest pain each year. Only 10%-15% are ultimately diagnosed with acute coronary syndrome (ACS), with most admitted to hospitals at a staggering cost of more than $3 billion annually.

The ACRIN PA 4005 trial randomized 1,370 patients with symptoms consistent with possible ACS from five clinical sites to undergo at least 64-slice CCTA or traditional evaluation, comprising mostly – but not limited to – exercise treadmill test, stress test with imaging, and stress echocardiography. They had an average TIMI (Thrombolysis in Myocardial Infarction) risk score of 0-2 and an electrocardiogram without acute ischemia. Their average age was about 50 years, and 60% were black.

Half of the 908 CCTA patients were discharged directly from the ED, compared with 23% of the 642 traditional-care patients (95% CI, 21.4-32.2).

The overall length of stay was 18 hours and 25 hours, respectively, but decreased even further to 12 hours for the 602 CCTA patients who had a negative scan, said Dr. Litt, chief of cardiovascular imaging at the University of Pennsylvania Health System in Philadelphia.

The CCTA group was also less likely than was the traditional-care group to have negative findings on invasive angiography (29% vs. 53%; 95% CI, –48.8-3.3).

The finding of more incidental CAD diagnoses in the CCTA arm vs. the traditional-care arm (9% vs. 3.5%; 95% CI, 0-11.2) is more problematic to interpret.

"Will this result in better prevention for them as they go on?" he asked. "Will they be encouraged to have lifestyle modifications and be put on statins, etc., resulting in lower future event rates and not showing up in the emergency room? Or will it just result in more testing that won’t be a benefit to them? We don’t know the answer to that."

No significant differences were observed in a 30-day resource utilization that included catheterization, revascularization, repeat ED visit, rehospitalization, and cardiologist visit. A 1-year follow-up is being obtained, and cost modeling will be conducted, he said. The possibility for substantial health care savings exists, however, as low- to intermediate-risk patients account for 50%-70% of cases presenting with possible ACS.

Overall, MI was reported within 30 days after presentation in 10 CCTA patientsand 5 traditional-care patients (1% vs. 11%; CI, –5.6-5.7). One serious adverse event (bradyarrhythmia) occurred in each group. There were no cardiac deaths in the traditional-care group.

Dr. Litt acknowledged that CCTA does increase radiation exposure, but said that radiation dosage is very technology dependent and that current technology has reduced the average radiation dose to less than that from nuclear myocardial perfusion studies. He also cautioned that the ACRIN PA 4005 results should not be extrapolated to groups with a higher risk of clinically significant coronary disease.

Invited discussant Dr. Thomas Gerber, a professor of medicine and radiology at Mayo Clinic in Jacksonville, Fla., asked why the investigators chose to focus on coronary CT angiography instead of the "triple rule-out" CT angiography strategy to evaluate the coronary arteries, pulmonary arteries, and thoracic aorta, and whether there were any patients who had pulmonary embolism or aortic dissection on subsequent evaluation.

Dr. Litt said they did track PE and acute aortic syndromes, and will report these findings in the future. The investigators used CCTA because they wanted to focus on patients in whom exclusion of ACS was the primary diagnostic question. He acknowledged that not all dissections are visible on CT, but added that "we are getting to the point where the radiology dose from a triple rule-out isn’t all that much higher than from a coronary CT. So in light of that new technology, that question may need to be reevaluated."

In a separate interview, Dr. James G. Adams, professor and chair of emergency medicine at Northwestern University in Chicago, said that no test is perfect, that all the evidence shows that coronary CT is at least as good as other testing strategies used in the initial evaluation of patients with acute chest pain, and that there are fewer hospital admissions.

"This [study] will certainly be used to promote coronary CT for patients at low to moderate risk of coronary disease," he said. "I believe that emergency physicians will increase their use."

Adoption of the CCTA approach depends on much more than whether emergency physicians find the results convincing, emergency physician Dr. Robert Solomon of Allegheny General Hospital in Pittsburgh said in an interview.

"Cardiology and radiology must also buy into it, and the resources necessary to enable clinicians to use this approach must be made available," he said. "This includes cardiologists, radiologists, and trained technologists. The necessary resources will not be available 24-7, even at tertiary care centers, so timing will always be an issue."

This study was sponsored by the Commonwealth of Pennsylvania Department of Health and the American Radiology Imaging Network Foundation. Dr. Litt reported grant funding and travel reimbursement from Siemens Medical Solutions and consulting fees from Medrad-Bayer. The study was simultaneously published online in the New England Journal of Medicine (2012 March 26 [doi:10.1056/NEJMoa1201163]).