Effect of PCI on Health Status in Ischemic Left Ventricular Dysfunction: Insights from REVIVED-BCIS2

Background In the Revascularization for Ischemic Ventricular Dysfunction (REVIVED-BCIS2) trial, percutaneous coronary intervention (PCI) did not reduce the incidence of death or hospitalization for heart failure. Objectives This prespecified secondary analysis investigated the effect of PCI on health status measured with the KCCQ combined with the primary outcome in a win ratio. Methods Participants with severe ischemic left ventricular dysfunction were randomized to either PCI in addition to optimal medical therapy (PCI) or optimal medical therapy alone (OMT). The primary outcome was a hierarchical composite of all-cause death, HHF and KCCQ overall summary score (OSS) at 24 months analysed using the unmatched win ratio. The key secondary endpoint was a KCCQ-OSS responder analysis. Results 347 participants were randomized to PCI and 353 to OMT. Median (IQR) age was 70.0 (63.3 to 76.1) years. Mean left ventricular ejection fraction was 27.0 ± 6.7 percent. PCI did not improve the primary endpoint (win ratio for PCI versus OMT, 1.05, 95% confidence interval, 0.88 to 1.26, p = 0.58). PCI resulted in more KCCQ-OSS responders than OMT at 6 months (55.7% vs. 41.0%, odds ratio (OR) 1.96 [95% CI 1.41 to 2.71], p < 0.001) and fewer deteriorators (23.9% vs. 31.2%, OR 0.69 [0.47 to 1.00], p = 0.048). PCI did not impact KCCQ-OSS responders or deteriorators at 12 or 24 months. Conclusion PCI did not improve the hierarchical composite of death, hospitalization for heart failure and health status at 2 years. PCI improved KCCQ-OSS at 6 months but this benefit was not sustained to 1- or 2-year follow-up.