Clinical Question

In patients with severe ischemic heart disease and a left ventricular ejection fraction (LVEF) of less than 35%, does percutaneous coronary intervention (PCI) improve outcomes?

Bottom Line

For patients with extensive ischemic heart disease and an LVEF of less than 35%, PCI provides no clear benefit. (Level of Evidence = 1b)

Synopsis

The investigators identified 700 patients with an LVEF of less than 35%, extensive coronary artery disease, and at least four myocardial segments amenable to revascularization (i.e., proven myocardial viability). Patients were randomized to receive 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 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 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), and 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.