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Clinical Question
In patients with severe ischemic heart disease and a left ventricular ejection fraction of less than 35%, does percutaneous coronary intervention improve outcomes?
Bottom line
For patients with extensive ischemic coronary disease and an LVEF of less than 35%, PCI provides no clear benefit. 1b
Reference
Study design: Randomized controlled trial (nonblinded)
Funding: Government
Setting: Outpatient (any)
Synopsis
These investigators identified 700 patients with a left ventricular ejection fraction (LVEF) of less than 35%, extensive coronary artery disease, and at least 4 myocardial segments amenable to revascularization (ie, proven myocardial viability). Patients were then randomized to receive percutaneous coronary intervention (PCI) or optimal medical therapy. At baseline, the mean age was 70 years, 87% were men, and 90% were white. The groups were generally balanced at baseline and analysis was by intention to treat. The study was powered to detect a 30% reduction in a composite of all-cause mortality and hospitalization for heart failure (hazard ratio = 0.70). Among patients assigned to the PCI group, 96.3% underwent PCI and the degree of successful anatomical revascularization was high (71%). After a median duration of follow-up of approximately 3.5 years, there was no significant difference in mortality between groups (31.7% for PCI vs 32.6% for medical therapy) and no difference in the number of patients with at least one hospitalization for heart failure (14.7% vs 15.3%). There was also no difference in the composite of these outcomes combined. Approximately 10% of patients in the medical therapy group underwent revascularization (largely due to episodes of acute coronary syndrome), while those in the PCI group had higher rates of major bleeding. Although quality-of-life scores favored the PCI group early on, by 24 months there was no longer any difference between groups. There were no differences for any prespecified subgroup analyses.
Reviewer
Mark H. Ebell, MD, MS
Professor
University of Georgia
Athens, GA