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Percutaneous Coronary Intervention Outcomes in Patients With Stable Obstructive Coronary Artery Disease and Myocardial Ischemia: A Collaborative Meta-Analysis of Contemporary Randomized Clinical Trials
Study Questions:
What is the effect of percutaneous coronary intervention (PCI) and medical therapy (MT) with MT alone exclusively in patients with stable coronary artery disease (CAD) and objectively documented myocardial ischemia on clinical outcomes?
Methods:
MEDLINE, Cochrane, and PubMed databases from 1970 to November 2012, were searched. Unpublished data were obtained from investigators. Randomized clinical trials of PCI and MT versus MT alone for stable CAD in which stents and statins were used in more than 50% of patients were included. For studies in which myocardial ischemia diagnosed by stress testing or fractional flow reserve was required for enrollment, descriptive and quantitative data were extracted from the published report. For studies in which myocardial ischemia was not a requirement for enrollment, authors provided data for only those patients with ischemia determined by stress testing prior to randomization. The outcomes analyzed included death from any cause, nonfatal myocardial infarction (MI), unplanned revascularization, and angina. Summary odds ratios (ORs) were obtained using a random-effects model. Heterogeneity was assessed using the Q statistic and I2.
Results:
In five trials enrolling 5,286 patients, myocardial ischemia was diagnosed in 4,064 patients by exercise stress testing, nuclear or echocardiographic stress imaging, or fractional flow reserve. Follow-up ranged from 231 days to 5 years (median, 5 years). The respective event rates for PCI with MT versus MT alone for death were 6.5% and 7.3% (odds ratio [OR], 0.90; 95% confidence interval [CI], 0.71-1.16); for nonfatal MI, 9.2% and 7.6% (OR, 1.24; 95% CI, 0.99-1.56); for unplanned revascularization, 18.3% and 28.4% (OR, 0.64; 95% CI, 0.35-1.17); and for angina, 20.3% and 23.3% (OR, 0.91; 95% CI, 0.57-1.44).
Conclusions:
The authors concluded that in patients with stable CAD and objectively documented myocardial ischemia, PCI with MT was not associated with a reduction in death, nonfatal MI, unplanned revascularization, or angina compared with MT alone.
Perspective:
The primary finding of this meta-analysis of patients with stable obstructive CAD and myocardial ischemia documented by stress testing or fractional flow reserve is that a strategy of initial PCI, in combination with MT, results in no significant reduction in mortality, nonfatal MI, unplanned revascularization, or angina compared with MT alone. These findings are unique in that this is the first meta-analysis limited to patients with documented, objective findings of myocardial ischemia, almost all of whom underwent treatment with intracoronary stents and disease-modifying secondary prevention therapy. These findings further support existing clinical practice guidelines that recommend an initial approach of contemporary guideline-based MT for patients with stable CAD and ischemia rather than proceeding directly to ischemia-guided PCI.
Keywords: Odds Ratio, Coronary Artery Disease, Myocardial Ischemia, Myocardial Infarction, Follow-Up Studies, Angioplasty, Percutaneous Coronary Intervention, Stents, Secondary Prevention, Cardiovascular Diseases, Confidence Intervals, Echocardiography, Exercise Test
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