Impact of baseline risk of death or hospitalisation on effectiveness of revascularisation in patients with ischaemic left ventricular dysfunction – a prespecified analysis of REVIVED-BCIS2

Background Randomized trials have failed to show a consistent benefit of revascularization in patients with ischaemic cardiomyopathy. This study aimed to investigate whether a participant’s baseline risk introduces heterogeneity in the treatment effect of percutaneous coronary intervention (PCI). Methods and results The REVIVED-BCIS2 trial randomised 700 participants with ischaemic cardiomyopathy to PCI plus optimal medical therapy (OMT) versus OMT alone, 263 (37.6%) of whom experienced the primary outcome (all-cause mortality or hospitalisation due to heart failure) during a median follow-up of 41 months. Pre-randomisation data were used to develop a prediction model for the primary outcome and evidence for heterogeneity of the trial intervention effect was investigated. The prediction model included 12 predictors and showed acceptable discrimination (C statistic: 0.69, 95% CI 0.66 to 0.72) and calibration (calibration slope: 0.79, 95% CI 0.64 to 0.95). Overall, there was no statistical evidence that the baseline risk score modified the trial intervention effect (pinteraction=0.21) on the primary outcome. For the secondary outcome of cardiovascular death or hospitalisation due to heart failure, weak evidence emerged that the baseline risk modified the trial intervention effect (pinteraction=0.044). Participants with lower baseline risk trended towards a greater benefit from PCI compared to participants with higher risk scores. Conclusion Baseline risk did not influence the effect of revascularisation in preventing all-cause mortality or hospitalisation due to heart failure. A trend was observed that lower baseline risk might be associated with more benefit of revascularisation in preventing cardiovascular death or hospitalisation due to heart failure. Clinicaltrials.gov identifier NCT01920048