BOSTON, MA — In an extended follow-up, no late benefit in survival emerged between COURAGE trial participants with stable CAD who received PCI as an initial strategy plus optimal medical therapy and those who received optimal medical therapy alone, a new analysis indicates. The findings from a follow-up averaging about 12 years are consistent with the tumultuous primary results.
"Prior to the COURAGE trial, most interventional cardiologists, including myself, assumed that PCI of ischemia-producing coronary blockages would lead to better outcomes and probably improve survival," Dr Steven Sedlis (New York Harbor Health Care System, NY) told heartwire from Medscape in written correspondence. "But there was a lingering concern that there could be long-term benefits to having unobstructed coronary arteries that might be discovered by longer observation of randomized patients," he added.
"Now, not finding any difference in survival after many more years of follow-up and after nearly half the patients have died effectively rules out the possibility of late benefit from initial PCI."
Results were published online November 12, 2015 in the New England Journal of Medicine.
As originally reported, COURAGE found no significant differences between patients who received initial PCI and those who did not with respect to the composite primary end point of death from any cause or nonfatal MI or in any of the other cardiac end points during a median follow-up of 4.6 years.
The new extended survival analysis was done to examine whether or not a potential long-term survival benefit from initial PCI might emerge after many more years of follow-up. Posttrial survival information was available for 1211 patients, or 53% of the original study population, for a median follow-up of 11.9 years.
Long-term mortality was virtually identical in patients treated with initial PCI vs initally only medical therapy: 25% vs 24%. In multivariate analysis, the hazard ratio (HR) for initial PCI vs no initial PCI was 1.03 (95% CI 0.83–1.21; P=0.76).
Previous prespecified and post hoc analyses of COURAGE trial data have tried to identify subgroups of patients who would benefit from an initial strategy of PCI, but no subgroup had been found to derive a survival benefit from additional PCI. "Similarly, in our extended survival analysis that included a cohort with a slightly higher risk profile than the risk profile of the overall study population, no survival benefit with initial PCI could be discerned during the extended follow-up," Sedlis observed.
However, a high rate of revascularization during the extended follow-up period would also reduce the likelihood of a divergence in mortality between the two study groups, as investigators add, suggesting that the late follow-up data may be less reflective of the initial treatment assignment than of a convergence of management strategies over time.
Sedlis had no relevant financial relationships. Disclosures for the coauthors are listed on the journal website.