Therapeutics
Review: In stable obstructive CAD, PCI plus medical therapy (MT) does not differ from MT alone
Stergiopoulos K, Boden WE, Hartigan P, et al. Percutaneous coronary intervention outcomes in patients with stable obstructive coronary artery disease and myocardial ischemia: a collaborative meta-analysis of contemporary randomized clinical trials. JAMA Intern Med. 2014; 174:232-40.
Clinical impact rating: C ★★★★★★✩ Question
Source of funding: No external funding.
In patients with stable obstructive coronary artery disease (CAD) and myocardial ischemia, what is the effect of percutaneous coronary intervention (PCI) plus medical therapy (MT) compared with MT alone on mortality and cardiovascular events?
For correspondence: Dr. D.L. Brown, State University of New York– Stony Brook School of Medicine, Stony Brook, NY, USA. E-mail [email protected]. ■
Commentary
Review scope Included studies compared PCI plus MT with MT alone in patients with stable CAD who had documented myocardial ischemia or abnormal fractional flow reserve (FFR) before randomization and included stents in ≥ 50% of PCI procedures and statins in ≥ 50% of patients in both treatment groups. Exclusion criteria were studies of patients who were stable after a completed myocardial infarction (MI) or that compared MT with any form of revascularization (PCI or coronary artery bypass grafting). Outcomes were all-cause mortality, unplanned revascularization, angina, and nonfatal MI, as defined in each trial.
Review methods MEDLINE and Cochrane Library (both to Nov 2012), reference lists, and reviews were searched for randomized controlled trials (RCTs). Authors were contacted for data on subsets of patients with myocardial ischemia at inclusion and for specific outcomes if not reported. 5 RCTs (n = 4064 with myocardial ischemia, mean age range 59 to 64 y, range 62% to 100% men, median follow-up 5 y) met selection criteria. MT could include aspirin, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, or statins. All trials were unblinded, reported followup, and had an independent outcome adjudicating committee.
Main results PCI plus MT did not differ from MT alone for all-cause mortality, unplanned revascularization, angina, or nonfatal MI (Table).
Conclusion In patients with stable obstructive coronary artery disease and myocardial ischemia, percutaneous coronary intervention plus medical therapy (MT) does not differ from MT alone for mortality and cardiovascular events. Percutaneous coronary intervention (PCI) plus medical therapy (MT) vs MT alone in stable obstructive coronary artery disease and myocardial ischemia* Outcomes All-cause mortality
Weighted event rates PCI + MT MT alone 6.6%
7.3%
At a median 5 y RRR (95% CI) 9% (−15 to 27)
Unplanned revascularization
20%
28%
29% (−12 to 57)
Angina
22%
23%
7% (−31 to 37)
RRI (CI) Nonfatal myocardial infarction
9.3%
7.6%
22% (−1 to 50)
*Abbreviations defined in Glossary. Weighted event rates, RRR, RRI, and CI calculated from control event rates and odds ratios in article using a random-effects model .
© 2014 American College of Physicians JC8 Downloaded From: http://annals.org/ by a University Hospital User on 04/29/2015
Randomized trials have failed to show improved clinical outcomes with PCI compared with MT alone in patients with stable CAD. Studies have included patients with and without demonstrable coronary ischemia, yet current guidelines (1) and cardiologist recommendations often advocate PCI in such patients, particularly when ST-segment changes, perfusion defects, or abnormal FFR are present. Using meta-analysis to combine results from 5 RCTs (Medicine, Angioplasty, or Surgery Study, Hambrecht and colleagues, COURAGE, BARI-2D, and FAME 2; total n = 5286), Stergiopoulos and colleagues compared outcomes of PCI and MT in 4064 patients with demonstrable ischemia. Addition of PCI did not reduce death, nonfatal MI, unplanned revascularization, or angina compared with optimal MT alone. Low utilization of drug-eluting stents and variability in MI definition and ascertainment across the 5 RCTs limit generalizability; however, the results are consistent with most previous studies, which showed the inability of PCI to prevent death or MI compared with MT in patients outside the setting of an acute coronary syndrome (2). Optimal MT with antiplatelets, statins, and antiangina agents should be the initial and predominant therapy for patients with stable CAD regardless of the presence or severity of coronary ischemia on noninvasive or FFR testing. PCI should be reserved for patients with unacceptable or recurrent angina. The ongoing International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (3) will contribute data on whether coronary angiography or revascularization improves outcomes compared with MT in patients with CAD and demonstrable ischemia. Michael P. Hudson, MD, FACC, MHS Henry Ford Hospital Detroit, Michigan, USA References 1. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/ PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012;60:e44-e164. 2. Pursnani S, Korley F, Gopaul R, et al. Percutaneous coronary intervention versus optimal medical therapy in stable coronary artery disease: a systematic review and meta-analysis of randomized clinical trials. Circ Cardiovasc Interv. 2012;5:476-90. 3. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial home page. www.ischemiatrial.org (accessed 26 Jan 2014). 15 April 2014 | ACP Journal Club | Volume 160 • Number 8
Review: In stable obstructive CAD, PCI plus medical therapy (MT) does not differ from MT alone
Stergiopoulos K, Boden WE, Hartigan P, et al. Percutaneous coronary intervention outcomes in patients with stable obstructive coronary artery disease and myocardial ischemia: a collaborative meta-analysis of contemporary randomized clinical trials. JAMA Intern Med. 2014; 174:232-40.
Clinical impact rating: C ★★★★★★✩ Question
Source of funding: No external funding.
In patients with stable obstructive coronary artery disease (CAD) and myocardial ischemia, what is the effect of percutaneous coronary intervention (PCI) plus medical therapy (MT) compared with MT alone on mortality and cardiovascular events?
For correspondence: Dr. D.L. Brown, State University of New York– Stony Brook School of Medicine, Stony Brook, NY, USA. E-mail [email protected]. ■
Commentary
Review scope Included studies compared PCI plus MT with MT alone in patients with stable CAD who had documented myocardial ischemia or abnormal fractional flow reserve (FFR) before randomization and included stents in ≥ 50% of PCI procedures and statins in ≥ 50% of patients in both treatment groups. Exclusion criteria were studies of patients who were stable after a completed myocardial infarction (MI) or that compared MT with any form of revascularization (PCI or coronary artery bypass grafting). Outcomes were all-cause mortality, unplanned revascularization, angina, and nonfatal MI, as defined in each trial.
Review methods MEDLINE and Cochrane Library (both to Nov 2012), reference lists, and reviews were searched for randomized controlled trials (RCTs). Authors were contacted for data on subsets of patients with myocardial ischemia at inclusion and for specific outcomes if not reported. 5 RCTs (n = 4064 with myocardial ischemia, mean age range 59 to 64 y, range 62% to 100% men, median follow-up 5 y) met selection criteria. MT could include aspirin, β-blockers, angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers, or statins. All trials were unblinded, reported followup, and had an independent outcome adjudicating committee.
Main results PCI plus MT did not differ from MT alone for all-cause mortality, unplanned revascularization, angina, or nonfatal MI (Table).
Conclusion In patients with stable obstructive coronary artery disease and myocardial ischemia, percutaneous coronary intervention plus medical therapy (MT) does not differ from MT alone for mortality and cardiovascular events. Percutaneous coronary intervention (PCI) plus medical therapy (MT) vs MT alone in stable obstructive coronary artery disease and myocardial ischemia* Outcomes All-cause mortality
Weighted event rates PCI + MT MT alone 6.6%
7.3%
At a median 5 y RRR (95% CI) 9% (−15 to 27)
Unplanned revascularization
20%
28%
29% (−12 to 57)
Angina
22%
23%
7% (−31 to 37)
RRI (CI) Nonfatal myocardial infarction
9.3%
7.6%
22% (−1 to 50)
*Abbreviations defined in Glossary. Weighted event rates, RRR, RRI, and CI calculated from control event rates and odds ratios in article using a random-effects model .
© 2014 American College of Physicians JC8 Downloaded From: http://annals.org/ by a University Hospital User on 04/29/2015
Randomized trials have failed to show improved clinical outcomes with PCI compared with MT alone in patients with stable CAD. Studies have included patients with and without demonstrable coronary ischemia, yet current guidelines (1) and cardiologist recommendations often advocate PCI in such patients, particularly when ST-segment changes, perfusion defects, or abnormal FFR are present. Using meta-analysis to combine results from 5 RCTs (Medicine, Angioplasty, or Surgery Study, Hambrecht and colleagues, COURAGE, BARI-2D, and FAME 2; total n = 5286), Stergiopoulos and colleagues compared outcomes of PCI and MT in 4064 patients with demonstrable ischemia. Addition of PCI did not reduce death, nonfatal MI, unplanned revascularization, or angina compared with optimal MT alone. Low utilization of drug-eluting stents and variability in MI definition and ascertainment across the 5 RCTs limit generalizability; however, the results are consistent with most previous studies, which showed the inability of PCI to prevent death or MI compared with MT in patients outside the setting of an acute coronary syndrome (2). Optimal MT with antiplatelets, statins, and antiangina agents should be the initial and predominant therapy for patients with stable CAD regardless of the presence or severity of coronary ischemia on noninvasive or FFR testing. PCI should be reserved for patients with unacceptable or recurrent angina. The ongoing International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (3) will contribute data on whether coronary angiography or revascularization improves outcomes compared with MT in patients with CAD and demonstrable ischemia. Michael P. Hudson, MD, FACC, MHS Henry Ford Hospital Detroit, Michigan, USA References 1. Fihn SD, Gardin JM, Abrams J, et al. 2012 ACCF/AHA/ACP/AATS/ PCNA/SCAI/STS guideline for the diagnosis and management of patients with stable ischemic heart disease: a report of the American College of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines, and the American College of Physicians, American Association for Thoracic Surgery, Preventive Cardiovascular Nurses Association, Society for Cardiovascular Angiography and Interventions, and Society of Thoracic Surgeons. J Am Coll Cardiol. 2012;60:e44-e164. 2. Pursnani S, Korley F, Gopaul R, et al. Percutaneous coronary intervention versus optimal medical therapy in stable coronary artery disease: a systematic review and meta-analysis of randomized clinical trials. Circ Cardiovasc Interv. 2012;5:476-90. 3. International Study of Comparative Health Effectiveness with Medical and Invasive Approaches (ISCHEMIA) Trial home page. www.ischemiatrial.org (accessed 26 Jan 2014). 15 April 2014 | ACP Journal Club | Volume 160 • Number 8
