Taishi Hirai MD

Study 1 Overview (STICHES Investigators)

Objective: To assess the survival benefit of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, compared to optimal medical therapy (OMT) alone, in patients with coronary artery disease, heart failure, and severe left ventricular dysfunction. Design: Multicenter, randomized, prospective study with extended follow-up (median duration of 9.8 years).

Setting and participants: A total of 1212 patients with left ventricular ejection fraction (LVEF) of 35% or less and coronary artery disease were randomized to medical therapy plus CABG or OMT alone at 127 clinical sites in 26 countries.

Main outcome measures: The primary endpoint was death from any cause. Main secondary endpoints were death from cardiovascular causes and a composite outcome of death from any cause or hospitalization for cardiovascular causes.

Main results: There were 359 primary outcome all-cause deaths (58.9%) in the CABG group and 398 (66.1%) in the medical therapy group (hazard ratio [HR], 0.84; 95% CI, 0.73-0.97; P = .02). Death from cardiovascular causes was reported in 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical therapy group (HR, 0.79; 95% CI, 0.66-0.93; P < .01). The composite outcome of death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and 467 patients (87.0%) in the medical therapy group (HR, 0.72; 95% CI, 0.64-0.82; P < .01).

Conclusion: Over a median follow-up of 9.8 years in patients with ischemic cardiomyopathy with severely reduced ejection fraction, the rates of death from any cause, death from cardiovascular causes, and the composite of death from any cause or hospitalization for cardiovascular causes were significantly lower in patients undergoing CABG than in patients receiving medical therapy alone.

Study 2 Overview (REVIVED BCIS Trial Group)

Objective: To assess whether percutaneous coronary intervention (PCI) can improve survival and left ventricular function in patients with severe left ventricular systolic dysfunction as compared to OMT alone.

Design: Multicenter, randomized, prospective study.

Setting and participants: A total of 700 patients with LVEF <35% with severe coronary artery disease amendable to PCI and demonstrable myocardial viability were randomly assigned to either PCI plus optimal medical therapy (PCI group) or OMT alone (OMT group).

Main outcome measures: The primary outcome was death from any cause or hospitalization for heart failure. The main secondary outcomes were LVEF at 6 and 12 months and quality of life (QOL) scores.

Main results: Over a median follow-up of 41 months, the primary outcome was reported in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the OMT group (HR, 0.99; 95% CI, 0.78-1.27; P = .96). The LVEF was similar in the 2 groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, –1.7 to 3.4). QOL scores at 6 and 12 months favored the PCI group, but the difference had diminished at 24 months.

Conclusion: In patients with severe ischemic cardiomyopathy, revascularization by PCI in addition to OMT did not result in a lower incidence of death from any cause or hospitalization from heart failure.

Commentary

Coronary artery disease is the most common cause of heart failure with reduced ejection fraction and an important cause of mortality.¹ Patients with ischemic cardiomyopathy with reduced ejection fraction are often considered for revascularization in addition to OMT and device therapies. Although there have been multiple retrospective studies and registries suggesting that cardiac outcomes and LVEF improve with revascularization, the number of large-scale prospective studies that assessed this clinical question and randomized patients to revascularization plus OMT compared to OMT alone has been limited.

In the Surgical Treatment for Ischemic Heart Failure (STICH) study,^2,3 eligible patients had coronary artery disease amendable to CABG and a LVEF of 35% or less. Patients (N = 1212) were randomly assigned to CABG plus OMT or OMT alone between July 2002 and May 2007. The original study, with a median follow-up of 5 years, did not show survival benefit, but the investigators reported that the primary outcome of death from any cause was significantly lower in the CABG group compared to OMT alone when follow-up of the same study population was extended to 9.8 years (58.9% vs 66.1%, P = .02). The findings from this study led to a class I guideline recommendation of CABG over medical therapy in patients with multivessel disease and low ejection fraction.⁴

Since the STICH trial was designed, there have been significant improvements in devices and techniques used for PCI, and the procedure is now widely performed in patients with multivessel disease.⁵ The advantages of PCI over CABG include shorter recovery times and lower risk of immediate complications. In this context, the recently reported Revascularization for Ischemic Ventricular Dysfunction (REVIVED) study assessed clinical outcomes in patients with severe coronary artery disease and reduced ejection fraction by randomizing patients to either PCI with OMT or OMT alone.⁶ At a median follow-up of 3.5 years, the investigators found no difference in the primary outcome of death from any cause or hospitalization for heart failure (37.2% vs 38.0%; 95% CI, 0.78-1.28; P = .96). Moreover, the degree of LVEF improvement, assessed by follow-up echocardiogram read by the core lab, showed no difference in the degree of LVEF improvement between groups at 6 and 12 months. Finally, although results of the QOL assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, patient-reported, heart-failure-specific QOL scale, favored the PCI group at 6 and 12 months of follow-up, the difference had diminished at 24 months.

The main strength of the REVIVED study was that it targeted a patient population with severe coronary artery disease, including left main disease and severely reduced ejection fraction, that historically have been excluded from large-scale randomized controlled studies evaluating PCI with OMT compared to OMT alone.⁷ However, there are several points to consider when interpreting the results of this study. First, further details of the PCI procedures are necessary. The REVIVED study recommended revascularization of all territories with viable myocardium; the anatomical revascularization index utilizing the British Cardiovascular Intervention Society (BCIS) Jeopardy Score was 71%. It is important to note that this jeopardy score was operator-reported and the core-lab adjudicated anatomical revascularization rate may be lower. Although viability testing primarily utilizing cardiac magnetic resonance imaging was performed in most patients, correlation between the revascularization territory and the viable segments has yet to be reported. Moreover, procedural details such as use of intravascular ultrasound and physiological testing, known to improve clinical outcome, need to be reported.^8,9

Second, there is a high prevalence of ischemic cardiomyopathy, and it is important to note that the patients included in this study were highly selected from daily clinical practice, as evidenced by the prolonged enrollment period (8 years). Individuals were largely stable patients with less complex coronary anatomy as evidenced by the median interval from angiography to randomization of 80 days. Taking into consideration the degree of left ventricular dysfunction for patients included in the trial, only 14% of the patients had left main disease and half of the patients only had 2-vessel disease. The severity of the left main disease also needs to be clarified as it is likely that patients the operator determined to be critical were not enrolled in the study. Furthermore, the standard of care based on the STICH trial is to refer patients with severe multivessel coronary artery disease to CABG, making it more likely that patients with more severe and complex disease were not included in this trial. It is also important to note that this study enrolled patients with stable ischemic heart disease, and the data do not apply to patients presenting with acute coronary syndrome.

Third, although the primary outcome was similar between the groups, the secondary outcome of unplanned revascularization was lower in the PCI group. In addition, the rate of acute myocardial infarction (MI) was similar between the 2 groups, but the rate of spontaneous MI was lower in the PCI group compared to the OMT group (5.2% vs 9.3%) as 40% of MI cases in the PCI group were periprocedural MIs. The correlation between periprocedural MI and long-term outcomes has been modest compared to spontaneous MI. Moreover, with the longer follow-up, the number of spontaneous MI cases is expected to rise while the number of periprocedural MI cases is not. Extending the follow-up period is also important, as the STICH extension trial showed a statistically significant difference at 10-year follow up despite negative results at the time of the original publication.

Fourth, the REVIVED trial randomized a significantly lower number of patients compared to the STICH trial, and the authors reported fewer primary-outcome events than the estimated number needed to achieve the power to assess the primary hypothesis. In addition, significant improvements in medical treatment for heart failure with reduced ejection fraction since the STICH trial make comparison of PCI vs CABG in this patient population unfeasible.

Finally, although severe angina was not an exclusion criterion, two-thirds of the patients enrolled had no angina, and only 2% of the patients had baseline severe angina. This is important to consider when interpreting the results of the patient-reported health status as previous studies have shown that patients with worse angina at baseline derive the largest improvement in their QOL,^10,11 and symptom improvement is the main indication for PCI in patients with stable ischemic heart disease.

Applications for Clinical Practice and System Implementation

In patients with severe left ventricular systolic dysfunction and multivessel stable ischemic heart disease who are well compensated and have little or no angina at baseline, OMT alone as an initial strategy may be considered against the addition of PCI after careful risk and benefit discussion. Further details about revascularization and extended follow-up data from the REVIVED trial are necessary.

Practice Points

• Patients with ischemic cardiomyopathy with reduced ejection fraction have been an understudied population in previous studies.
• Further studies are necessary to understand the benefits of revascularization and the role of viability testing in this population.

– Taishi Hirai MD, and Ziad Sayed Ahmad, MD
University of Missouri, Columbia, MO

Study 1 Overview (STICHES Investigators)

Objective: To assess the survival benefit of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, compared to optimal medical therapy (OMT) alone, in patients with coronary artery disease, heart failure, and severe left ventricular dysfunction. Design: Multicenter, randomized, prospective study with extended follow-up (median duration of 9.8 years).

Setting and participants: A total of 1212 patients with left ventricular ejection fraction (LVEF) of 35% or less and coronary artery disease were randomized to medical therapy plus CABG or OMT alone at 127 clinical sites in 26 countries.

Main outcome measures: The primary endpoint was death from any cause. Main secondary endpoints were death from cardiovascular causes and a composite outcome of death from any cause or hospitalization for cardiovascular causes.

Main results: There were 359 primary outcome all-cause deaths (58.9%) in the CABG group and 398 (66.1%) in the medical therapy group (hazard ratio [HR], 0.84; 95% CI, 0.73-0.97; P = .02). Death from cardiovascular causes was reported in 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical therapy group (HR, 0.79; 95% CI, 0.66-0.93; P < .01). The composite outcome of death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and 467 patients (87.0%) in the medical therapy group (HR, 0.72; 95% CI, 0.64-0.82; P < .01).

Conclusion: Over a median follow-up of 9.8 years in patients with ischemic cardiomyopathy with severely reduced ejection fraction, the rates of death from any cause, death from cardiovascular causes, and the composite of death from any cause or hospitalization for cardiovascular causes were significantly lower in patients undergoing CABG than in patients receiving medical therapy alone.

Study 2 Overview (REVIVED BCIS Trial Group)

Objective: To assess whether percutaneous coronary intervention (PCI) can improve survival and left ventricular function in patients with severe left ventricular systolic dysfunction as compared to OMT alone.

Design: Multicenter, randomized, prospective study.

Setting and participants: A total of 700 patients with LVEF <35% with severe coronary artery disease amendable to PCI and demonstrable myocardial viability were randomly assigned to either PCI plus optimal medical therapy (PCI group) or OMT alone (OMT group).

Main outcome measures: The primary outcome was death from any cause or hospitalization for heart failure. The main secondary outcomes were LVEF at 6 and 12 months and quality of life (QOL) scores.

Main results: Over a median follow-up of 41 months, the primary outcome was reported in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the OMT group (HR, 0.99; 95% CI, 0.78-1.27; P = .96). The LVEF was similar in the 2 groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, –1.7 to 3.4). QOL scores at 6 and 12 months favored the PCI group, but the difference had diminished at 24 months.

Conclusion: In patients with severe ischemic cardiomyopathy, revascularization by PCI in addition to OMT did not result in a lower incidence of death from any cause or hospitalization from heart failure.

Commentary

Coronary artery disease is the most common cause of heart failure with reduced ejection fraction and an important cause of mortality.¹ Patients with ischemic cardiomyopathy with reduced ejection fraction are often considered for revascularization in addition to OMT and device therapies. Although there have been multiple retrospective studies and registries suggesting that cardiac outcomes and LVEF improve with revascularization, the number of large-scale prospective studies that assessed this clinical question and randomized patients to revascularization plus OMT compared to OMT alone has been limited.

In the Surgical Treatment for Ischemic Heart Failure (STICH) study,^2,3 eligible patients had coronary artery disease amendable to CABG and a LVEF of 35% or less. Patients (N = 1212) were randomly assigned to CABG plus OMT or OMT alone between July 2002 and May 2007. The original study, with a median follow-up of 5 years, did not show survival benefit, but the investigators reported that the primary outcome of death from any cause was significantly lower in the CABG group compared to OMT alone when follow-up of the same study population was extended to 9.8 years (58.9% vs 66.1%, P = .02). The findings from this study led to a class I guideline recommendation of CABG over medical therapy in patients with multivessel disease and low ejection fraction.⁴

Since the STICH trial was designed, there have been significant improvements in devices and techniques used for PCI, and the procedure is now widely performed in patients with multivessel disease.⁵ The advantages of PCI over CABG include shorter recovery times and lower risk of immediate complications. In this context, the recently reported Revascularization for Ischemic Ventricular Dysfunction (REVIVED) study assessed clinical outcomes in patients with severe coronary artery disease and reduced ejection fraction by randomizing patients to either PCI with OMT or OMT alone.⁶ At a median follow-up of 3.5 years, the investigators found no difference in the primary outcome of death from any cause or hospitalization for heart failure (37.2% vs 38.0%; 95% CI, 0.78-1.28; P = .96). Moreover, the degree of LVEF improvement, assessed by follow-up echocardiogram read by the core lab, showed no difference in the degree of LVEF improvement between groups at 6 and 12 months. Finally, although results of the QOL assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, patient-reported, heart-failure-specific QOL scale, favored the PCI group at 6 and 12 months of follow-up, the difference had diminished at 24 months.

The main strength of the REVIVED study was that it targeted a patient population with severe coronary artery disease, including left main disease and severely reduced ejection fraction, that historically have been excluded from large-scale randomized controlled studies evaluating PCI with OMT compared to OMT alone.⁷ However, there are several points to consider when interpreting the results of this study. First, further details of the PCI procedures are necessary. The REVIVED study recommended revascularization of all territories with viable myocardium; the anatomical revascularization index utilizing the British Cardiovascular Intervention Society (BCIS) Jeopardy Score was 71%. It is important to note that this jeopardy score was operator-reported and the core-lab adjudicated anatomical revascularization rate may be lower. Although viability testing primarily utilizing cardiac magnetic resonance imaging was performed in most patients, correlation between the revascularization territory and the viable segments has yet to be reported. Moreover, procedural details such as use of intravascular ultrasound and physiological testing, known to improve clinical outcome, need to be reported.^8,9

Second, there is a high prevalence of ischemic cardiomyopathy, and it is important to note that the patients included in this study were highly selected from daily clinical practice, as evidenced by the prolonged enrollment period (8 years). Individuals were largely stable patients with less complex coronary anatomy as evidenced by the median interval from angiography to randomization of 80 days. Taking into consideration the degree of left ventricular dysfunction for patients included in the trial, only 14% of the patients had left main disease and half of the patients only had 2-vessel disease. The severity of the left main disease also needs to be clarified as it is likely that patients the operator determined to be critical were not enrolled in the study. Furthermore, the standard of care based on the STICH trial is to refer patients with severe multivessel coronary artery disease to CABG, making it more likely that patients with more severe and complex disease were not included in this trial. It is also important to note that this study enrolled patients with stable ischemic heart disease, and the data do not apply to patients presenting with acute coronary syndrome.

Third, although the primary outcome was similar between the groups, the secondary outcome of unplanned revascularization was lower in the PCI group. In addition, the rate of acute myocardial infarction (MI) was similar between the 2 groups, but the rate of spontaneous MI was lower in the PCI group compared to the OMT group (5.2% vs 9.3%) as 40% of MI cases in the PCI group were periprocedural MIs. The correlation between periprocedural MI and long-term outcomes has been modest compared to spontaneous MI. Moreover, with the longer follow-up, the number of spontaneous MI cases is expected to rise while the number of periprocedural MI cases is not. Extending the follow-up period is also important, as the STICH extension trial showed a statistically significant difference at 10-year follow up despite negative results at the time of the original publication.

Fourth, the REVIVED trial randomized a significantly lower number of patients compared to the STICH trial, and the authors reported fewer primary-outcome events than the estimated number needed to achieve the power to assess the primary hypothesis. In addition, significant improvements in medical treatment for heart failure with reduced ejection fraction since the STICH trial make comparison of PCI vs CABG in this patient population unfeasible.

Finally, although severe angina was not an exclusion criterion, two-thirds of the patients enrolled had no angina, and only 2% of the patients had baseline severe angina. This is important to consider when interpreting the results of the patient-reported health status as previous studies have shown that patients with worse angina at baseline derive the largest improvement in their QOL,^10,11 and symptom improvement is the main indication for PCI in patients with stable ischemic heart disease.

Applications for Clinical Practice and System Implementation

In patients with severe left ventricular systolic dysfunction and multivessel stable ischemic heart disease who are well compensated and have little or no angina at baseline, OMT alone as an initial strategy may be considered against the addition of PCI after careful risk and benefit discussion. Further details about revascularization and extended follow-up data from the REVIVED trial are necessary.

Practice Points

• Patients with ischemic cardiomyopathy with reduced ejection fraction have been an understudied population in previous studies.
• Further studies are necessary to understand the benefits of revascularization and the role of viability testing in this population.

– Taishi Hirai MD, and Ziad Sayed Ahmad, MD
University of Missouri, Columbia, MO

Study 1 Overview (STICHES Investigators)

Objective: To assess the survival benefit of coronary-artery bypass grafting (CABG) added to guideline-directed medical therapy, compared to optimal medical therapy (OMT) alone, in patients with coronary artery disease, heart failure, and severe left ventricular dysfunction. Design: Multicenter, randomized, prospective study with extended follow-up (median duration of 9.8 years).

Setting and participants: A total of 1212 patients with left ventricular ejection fraction (LVEF) of 35% or less and coronary artery disease were randomized to medical therapy plus CABG or OMT alone at 127 clinical sites in 26 countries.

Main outcome measures: The primary endpoint was death from any cause. Main secondary endpoints were death from cardiovascular causes and a composite outcome of death from any cause or hospitalization for cardiovascular causes.

Main results: There were 359 primary outcome all-cause deaths (58.9%) in the CABG group and 398 (66.1%) in the medical therapy group (hazard ratio [HR], 0.84; 95% CI, 0.73-0.97; P = .02). Death from cardiovascular causes was reported in 247 patients (40.5%) in the CABG group and 297 patients (49.3%) in the medical therapy group (HR, 0.79; 95% CI, 0.66-0.93; P < .01). The composite outcome of death from any cause or hospitalization for cardiovascular causes occurred in 467 patients (76.6%) in the CABG group and 467 patients (87.0%) in the medical therapy group (HR, 0.72; 95% CI, 0.64-0.82; P < .01).

Conclusion: Over a median follow-up of 9.8 years in patients with ischemic cardiomyopathy with severely reduced ejection fraction, the rates of death from any cause, death from cardiovascular causes, and the composite of death from any cause or hospitalization for cardiovascular causes were significantly lower in patients undergoing CABG than in patients receiving medical therapy alone.

Study 2 Overview (REVIVED BCIS Trial Group)

Objective: To assess whether percutaneous coronary intervention (PCI) can improve survival and left ventricular function in patients with severe left ventricular systolic dysfunction as compared to OMT alone.

Design: Multicenter, randomized, prospective study.

Setting and participants: A total of 700 patients with LVEF <35% with severe coronary artery disease amendable to PCI and demonstrable myocardial viability were randomly assigned to either PCI plus optimal medical therapy (PCI group) or OMT alone (OMT group).

Main outcome measures: The primary outcome was death from any cause or hospitalization for heart failure. The main secondary outcomes were LVEF at 6 and 12 months and quality of life (QOL) scores.

Main results: Over a median follow-up of 41 months, the primary outcome was reported in 129 patients (37.2%) in the PCI group and in 134 patients (38.0%) in the OMT group (HR, 0.99; 95% CI, 0.78-1.27; P = .96). The LVEF was similar in the 2 groups at 6 months (mean difference, –1.6 percentage points; 95% CI, –3.7 to 0.5) and at 12 months (mean difference, 0.9 percentage points; 95% CI, –1.7 to 3.4). QOL scores at 6 and 12 months favored the PCI group, but the difference had diminished at 24 months.

Conclusion: In patients with severe ischemic cardiomyopathy, revascularization by PCI in addition to OMT did not result in a lower incidence of death from any cause or hospitalization from heart failure.

Commentary

Coronary artery disease is the most common cause of heart failure with reduced ejection fraction and an important cause of mortality.¹ Patients with ischemic cardiomyopathy with reduced ejection fraction are often considered for revascularization in addition to OMT and device therapies. Although there have been multiple retrospective studies and registries suggesting that cardiac outcomes and LVEF improve with revascularization, the number of large-scale prospective studies that assessed this clinical question and randomized patients to revascularization plus OMT compared to OMT alone has been limited.

In the Surgical Treatment for Ischemic Heart Failure (STICH) study,^2,3 eligible patients had coronary artery disease amendable to CABG and a LVEF of 35% or less. Patients (N = 1212) were randomly assigned to CABG plus OMT or OMT alone between July 2002 and May 2007. The original study, with a median follow-up of 5 years, did not show survival benefit, but the investigators reported that the primary outcome of death from any cause was significantly lower in the CABG group compared to OMT alone when follow-up of the same study population was extended to 9.8 years (58.9% vs 66.1%, P = .02). The findings from this study led to a class I guideline recommendation of CABG over medical therapy in patients with multivessel disease and low ejection fraction.⁴

Since the STICH trial was designed, there have been significant improvements in devices and techniques used for PCI, and the procedure is now widely performed in patients with multivessel disease.⁵ The advantages of PCI over CABG include shorter recovery times and lower risk of immediate complications. In this context, the recently reported Revascularization for Ischemic Ventricular Dysfunction (REVIVED) study assessed clinical outcomes in patients with severe coronary artery disease and reduced ejection fraction by randomizing patients to either PCI with OMT or OMT alone.⁶ At a median follow-up of 3.5 years, the investigators found no difference in the primary outcome of death from any cause or hospitalization for heart failure (37.2% vs 38.0%; 95% CI, 0.78-1.28; P = .96). Moreover, the degree of LVEF improvement, assessed by follow-up echocardiogram read by the core lab, showed no difference in the degree of LVEF improvement between groups at 6 and 12 months. Finally, although results of the QOL assessment using the Kansas City Cardiomyopathy Questionnaire (KCCQ), a validated, patient-reported, heart-failure-specific QOL scale, favored the PCI group at 6 and 12 months of follow-up, the difference had diminished at 24 months.

The main strength of the REVIVED study was that it targeted a patient population with severe coronary artery disease, including left main disease and severely reduced ejection fraction, that historically have been excluded from large-scale randomized controlled studies evaluating PCI with OMT compared to OMT alone.⁷ However, there are several points to consider when interpreting the results of this study. First, further details of the PCI procedures are necessary. The REVIVED study recommended revascularization of all territories with viable myocardium; the anatomical revascularization index utilizing the British Cardiovascular Intervention Society (BCIS) Jeopardy Score was 71%. It is important to note that this jeopardy score was operator-reported and the core-lab adjudicated anatomical revascularization rate may be lower. Although viability testing primarily utilizing cardiac magnetic resonance imaging was performed in most patients, correlation between the revascularization territory and the viable segments has yet to be reported. Moreover, procedural details such as use of intravascular ultrasound and physiological testing, known to improve clinical outcome, need to be reported.^8,9

Second, there is a high prevalence of ischemic cardiomyopathy, and it is important to note that the patients included in this study were highly selected from daily clinical practice, as evidenced by the prolonged enrollment period (8 years). Individuals were largely stable patients with less complex coronary anatomy as evidenced by the median interval from angiography to randomization of 80 days. Taking into consideration the degree of left ventricular dysfunction for patients included in the trial, only 14% of the patients had left main disease and half of the patients only had 2-vessel disease. The severity of the left main disease also needs to be clarified as it is likely that patients the operator determined to be critical were not enrolled in the study. Furthermore, the standard of care based on the STICH trial is to refer patients with severe multivessel coronary artery disease to CABG, making it more likely that patients with more severe and complex disease were not included in this trial. It is also important to note that this study enrolled patients with stable ischemic heart disease, and the data do not apply to patients presenting with acute coronary syndrome.

Third, although the primary outcome was similar between the groups, the secondary outcome of unplanned revascularization was lower in the PCI group. In addition, the rate of acute myocardial infarction (MI) was similar between the 2 groups, but the rate of spontaneous MI was lower in the PCI group compared to the OMT group (5.2% vs 9.3%) as 40% of MI cases in the PCI group were periprocedural MIs. The correlation between periprocedural MI and long-term outcomes has been modest compared to spontaneous MI. Moreover, with the longer follow-up, the number of spontaneous MI cases is expected to rise while the number of periprocedural MI cases is not. Extending the follow-up period is also important, as the STICH extension trial showed a statistically significant difference at 10-year follow up despite negative results at the time of the original publication.

Fourth, the REVIVED trial randomized a significantly lower number of patients compared to the STICH trial, and the authors reported fewer primary-outcome events than the estimated number needed to achieve the power to assess the primary hypothesis. In addition, significant improvements in medical treatment for heart failure with reduced ejection fraction since the STICH trial make comparison of PCI vs CABG in this patient population unfeasible.

Finally, although severe angina was not an exclusion criterion, two-thirds of the patients enrolled had no angina, and only 2% of the patients had baseline severe angina. This is important to consider when interpreting the results of the patient-reported health status as previous studies have shown that patients with worse angina at baseline derive the largest improvement in their QOL,^10,11 and symptom improvement is the main indication for PCI in patients with stable ischemic heart disease.

Applications for Clinical Practice and System Implementation

In patients with severe left ventricular systolic dysfunction and multivessel stable ischemic heart disease who are well compensated and have little or no angina at baseline, OMT alone as an initial strategy may be considered against the addition of PCI after careful risk and benefit discussion. Further details about revascularization and extended follow-up data from the REVIVED trial are necessary.

Practice Points

• Patients with ischemic cardiomyopathy with reduced ejection fraction have been an understudied population in previous studies.
• Further studies are necessary to understand the benefits of revascularization and the role of viability testing in this population.

– Taishi Hirai MD, and Ziad Sayed Ahmad, MD
University of Missouri, Columbia, MO

Study Overview

Objective: To assess the safety and efficacy of early hospital discharge (EHD) for selected low-risk patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).

Design: Single-center retrospective analysis of prospectively collected data.

Setting and participants: An EHD group comprised of 600 patients who were discharged at <48 hours between April 2020 and June 2021 was compared to a control group of 700 patients who met EHD criteria but were discharged at >48 hour between October 2018 and June 2021. Patients were selected into the EHD group based on the following criteria, in accordance with recommendations from the European Society of Cardiology, and all patients had close follow-up with a combination of structured telephone follow-up at 48 hours post discharge and virtual visits at 2, 6, and 8 weeks and at 3 months:

• Left ventricular ejection fraction ≥40%
• Successful primary PCI (that achieved thrombolysis in myocardial infarction flow grade 3)
• Absence of severe nonculprit disease requiring further inpatient revascularization
• Absence of ischemic symptoms post PCI
• Absence of heart failure or hemodynamic instability
• Absence of significant arrhythmia (ventricular fibrillation, ventricular tachycardia, or atrial fibrillation or atrial flutter requiring prolonged stay)
• Mobility with suitable social circumstances for discharge

Main outcome measures: The outcomes measured were length of hospitalization and a composite primary endpoint of cardiovascular mortality and major adverse cardiovascular event (MACE) rates, defined as a composite of all-cause mortality, recurrent MI, and target lesion revascularization.

Main results: The median length of stay of hospitalization in the EHD group was 24.6 hours compared to 56.1 hours in the >48-hour historical control group. On median follow-up of 271 days, the EHD group demonstrated 0% cardiovascular mortality and a MACE rate of 1.2%. This was shown to be noninferior compared to the >48-hour historical control group, which had mortality of 0.7% and a MACE rate of 1.9%.

Conclusion: Selected low-risk STEMI patients can be safely discharged early with appropriate follow-up after primary PCI.

Commentary

Patients with STEMI have a higher risk of postprocedural adverse events such as MI, arrhythmia, or acute heart failure compared to patients with stable ischemic heart disease, and thus are monitored after primary PCI. Although patients were traditionally monitored for 5 to 7 days a few decades ago,¹ with improvements in PCI techniques, devices, and pharmacotherapy as well as in door-to-balloon time, the in-hospital complication rates for patients with STEMI have been decreasing, leading to earlier discharge. Currently in the United States, patients are most commonly monitored for 48 to 72 hours post PCI.² The current guidelines support this practice, recommending early discharge within 48 to 72 hours in selected low-risk patients if adequate follow-up and rehabilitation are arranged.³

Given the COVID-19 pandemic and decreased hospital bed availability, Rathod et al took one step further on the question of whether low-risk STEMI patients with primary PCI can be discharged safely within 48 hours with adequate follow-up. They found that at a median follow-up of 271 days, EHD patients had 2 COVID-related deaths, with 0% cardiovascular mortality and a MACE rate of 1.2%, including deaths, MI, and ischemic revascularization. The median time to discharge was 25 hours. This was noninferior to the >48-hour historical control group, which had mortality of 0.7% (P = 0.349) and a MACE rate of 1.9% (P = .674). The results remained similar after propensity matching for mortality (0.34% vs 0.69%, P = .410) or MACE (1.2% vs 1.9%, P = .342).

This is the first prospective study to systematically assess the safety and feasibility of discharge of low-risk STEMI patients with primary PCI within 48 hours. This study is unique in that it involved the use of telemedicine, including a virtual platform to collect data such as heart rate, blood pressure, and blood glucose, and virtual visits to facilitate follow-up and reduce clinic travel, cost, and potential COVID-19 exposure. The investigators’ protocol included virtual follow-up by cardiology advanced practitioners at 2, 6, and 8 weeks and by an interventional cardiologist at 12 weeks. This protocol led to an increase in patient satisfaction. The study’s main limitation is that it is a single-center trial with a smaller sample size. Further studies are necessary to confirm the safety and feasibility of this approach. In addition, further refinement of the patient selection criteria for EHD should be considered.

Applications for Clinical Practice

In low-risk STEMI patients after primary PCI, discharge within 48 hours may be considered if close follow-up is arranged. However, further studies are necessary to confirm this finding.

—Thai Nguyen, MD, Albert Chan, MD, and Taishi Hirai MD

Study Overview

Objective: To assess the safety and efficacy of early hospital discharge (EHD) for selected low-risk patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).

Design: Single-center retrospective analysis of prospectively collected data.

Setting and participants: An EHD group comprised of 600 patients who were discharged at <48 hours between April 2020 and June 2021 was compared to a control group of 700 patients who met EHD criteria but were discharged at >48 hour between October 2018 and June 2021. Patients were selected into the EHD group based on the following criteria, in accordance with recommendations from the European Society of Cardiology, and all patients had close follow-up with a combination of structured telephone follow-up at 48 hours post discharge and virtual visits at 2, 6, and 8 weeks and at 3 months:

• Left ventricular ejection fraction ≥40%
• Successful primary PCI (that achieved thrombolysis in myocardial infarction flow grade 3)
• Absence of severe nonculprit disease requiring further inpatient revascularization
• Absence of ischemic symptoms post PCI
• Absence of heart failure or hemodynamic instability
• Absence of significant arrhythmia (ventricular fibrillation, ventricular tachycardia, or atrial fibrillation or atrial flutter requiring prolonged stay)
• Mobility with suitable social circumstances for discharge

Main outcome measures: The outcomes measured were length of hospitalization and a composite primary endpoint of cardiovascular mortality and major adverse cardiovascular event (MACE) rates, defined as a composite of all-cause mortality, recurrent MI, and target lesion revascularization.

Main results: The median length of stay of hospitalization in the EHD group was 24.6 hours compared to 56.1 hours in the >48-hour historical control group. On median follow-up of 271 days, the EHD group demonstrated 0% cardiovascular mortality and a MACE rate of 1.2%. This was shown to be noninferior compared to the >48-hour historical control group, which had mortality of 0.7% and a MACE rate of 1.9%.

Conclusion: Selected low-risk STEMI patients can be safely discharged early with appropriate follow-up after primary PCI.

Commentary

Patients with STEMI have a higher risk of postprocedural adverse events such as MI, arrhythmia, or acute heart failure compared to patients with stable ischemic heart disease, and thus are monitored after primary PCI. Although patients were traditionally monitored for 5 to 7 days a few decades ago,¹ with improvements in PCI techniques, devices, and pharmacotherapy as well as in door-to-balloon time, the in-hospital complication rates for patients with STEMI have been decreasing, leading to earlier discharge. Currently in the United States, patients are most commonly monitored for 48 to 72 hours post PCI.² The current guidelines support this practice, recommending early discharge within 48 to 72 hours in selected low-risk patients if adequate follow-up and rehabilitation are arranged.³

Given the COVID-19 pandemic and decreased hospital bed availability, Rathod et al took one step further on the question of whether low-risk STEMI patients with primary PCI can be discharged safely within 48 hours with adequate follow-up. They found that at a median follow-up of 271 days, EHD patients had 2 COVID-related deaths, with 0% cardiovascular mortality and a MACE rate of 1.2%, including deaths, MI, and ischemic revascularization. The median time to discharge was 25 hours. This was noninferior to the >48-hour historical control group, which had mortality of 0.7% (P = 0.349) and a MACE rate of 1.9% (P = .674). The results remained similar after propensity matching for mortality (0.34% vs 0.69%, P = .410) or MACE (1.2% vs 1.9%, P = .342).

This is the first prospective study to systematically assess the safety and feasibility of discharge of low-risk STEMI patients with primary PCI within 48 hours. This study is unique in that it involved the use of telemedicine, including a virtual platform to collect data such as heart rate, blood pressure, and blood glucose, and virtual visits to facilitate follow-up and reduce clinic travel, cost, and potential COVID-19 exposure. The investigators’ protocol included virtual follow-up by cardiology advanced practitioners at 2, 6, and 8 weeks and by an interventional cardiologist at 12 weeks. This protocol led to an increase in patient satisfaction. The study’s main limitation is that it is a single-center trial with a smaller sample size. Further studies are necessary to confirm the safety and feasibility of this approach. In addition, further refinement of the patient selection criteria for EHD should be considered.

Applications for Clinical Practice

In low-risk STEMI patients after primary PCI, discharge within 48 hours may be considered if close follow-up is arranged. However, further studies are necessary to confirm this finding.

—Thai Nguyen, MD, Albert Chan, MD, and Taishi Hirai MD

Study Overview

Objective: To assess the safety and efficacy of early hospital discharge (EHD) for selected low-risk patients with ST-segment elevation myocardial infarction (STEMI) after primary percutaneous coronary intervention (PCI).

Design: Single-center retrospective analysis of prospectively collected data.

Setting and participants: An EHD group comprised of 600 patients who were discharged at <48 hours between April 2020 and June 2021 was compared to a control group of 700 patients who met EHD criteria but were discharged at >48 hour between October 2018 and June 2021. Patients were selected into the EHD group based on the following criteria, in accordance with recommendations from the European Society of Cardiology, and all patients had close follow-up with a combination of structured telephone follow-up at 48 hours post discharge and virtual visits at 2, 6, and 8 weeks and at 3 months:

• Left ventricular ejection fraction ≥40%
• Successful primary PCI (that achieved thrombolysis in myocardial infarction flow grade 3)
• Absence of severe nonculprit disease requiring further inpatient revascularization
• Absence of ischemic symptoms post PCI
• Absence of heart failure or hemodynamic instability
• Absence of significant arrhythmia (ventricular fibrillation, ventricular tachycardia, or atrial fibrillation or atrial flutter requiring prolonged stay)
• Mobility with suitable social circumstances for discharge

Main outcome measures: The outcomes measured were length of hospitalization and a composite primary endpoint of cardiovascular mortality and major adverse cardiovascular event (MACE) rates, defined as a composite of all-cause mortality, recurrent MI, and target lesion revascularization.

Main results: The median length of stay of hospitalization in the EHD group was 24.6 hours compared to 56.1 hours in the >48-hour historical control group. On median follow-up of 271 days, the EHD group demonstrated 0% cardiovascular mortality and a MACE rate of 1.2%. This was shown to be noninferior compared to the >48-hour historical control group, which had mortality of 0.7% and a MACE rate of 1.9%.

Conclusion: Selected low-risk STEMI patients can be safely discharged early with appropriate follow-up after primary PCI.

Commentary

Patients with STEMI have a higher risk of postprocedural adverse events such as MI, arrhythmia, or acute heart failure compared to patients with stable ischemic heart disease, and thus are monitored after primary PCI. Although patients were traditionally monitored for 5 to 7 days a few decades ago,¹ with improvements in PCI techniques, devices, and pharmacotherapy as well as in door-to-balloon time, the in-hospital complication rates for patients with STEMI have been decreasing, leading to earlier discharge. Currently in the United States, patients are most commonly monitored for 48 to 72 hours post PCI.² The current guidelines support this practice, recommending early discharge within 48 to 72 hours in selected low-risk patients if adequate follow-up and rehabilitation are arranged.³

Given the COVID-19 pandemic and decreased hospital bed availability, Rathod et al took one step further on the question of whether low-risk STEMI patients with primary PCI can be discharged safely within 48 hours with adequate follow-up. They found that at a median follow-up of 271 days, EHD patients had 2 COVID-related deaths, with 0% cardiovascular mortality and a MACE rate of 1.2%, including deaths, MI, and ischemic revascularization. The median time to discharge was 25 hours. This was noninferior to the >48-hour historical control group, which had mortality of 0.7% (P = 0.349) and a MACE rate of 1.9% (P = .674). The results remained similar after propensity matching for mortality (0.34% vs 0.69%, P = .410) or MACE (1.2% vs 1.9%, P = .342).

This is the first prospective study to systematically assess the safety and feasibility of discharge of low-risk STEMI patients with primary PCI within 48 hours. This study is unique in that it involved the use of telemedicine, including a virtual platform to collect data such as heart rate, blood pressure, and blood glucose, and virtual visits to facilitate follow-up and reduce clinic travel, cost, and potential COVID-19 exposure. The investigators’ protocol included virtual follow-up by cardiology advanced practitioners at 2, 6, and 8 weeks and by an interventional cardiologist at 12 weeks. This protocol led to an increase in patient satisfaction. The study’s main limitation is that it is a single-center trial with a smaller sample size. Further studies are necessary to confirm the safety and feasibility of this approach. In addition, further refinement of the patient selection criteria for EHD should be considered.

Applications for Clinical Practice

In low-risk STEMI patients after primary PCI, discharge within 48 hours may be considered if close follow-up is arranged. However, further studies are necessary to confirm this finding.

—Thai Nguyen, MD, Albert Chan, MD, and Taishi Hirai MD