European heart journal. Quality of care & clinical outcomes · 2025
Impact of baseline risk of death or hospitalization on effectiveness of revascularization in patients with ischaemic left ventricular dysfunction-a prespecified analysis of REVIVED-BCIS2.
СтатьяРандомизированное исследованиеМногоцентровое исследованиеНазвание и аннотация: Перевод в очереди
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Ovesen Christian, Dodd Matthew, Ryan Matthew, Clayton Tim, Sharples Linda, Perera Divaka
Аннотация
AIMS: 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) vs. OMT alone, 263 (37.6%) of whom experienced the primary outcome (all-cause mortality or hospitalization due to heart failure) during a median follow-up of 41 months. Pre-randomization 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 0.66-0.72) and calibration (calibration slope: 0.79, 95% CI 0.64-0.95). 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 hospitalization 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 with participants with higher risk scores.
CONCLUSION: Baseline risk did not influence the effect of revascularization in preventing all-cause mortality or hospitalization due to heart failure. A trend was observed that lower baseline risk might be associated with more benefit of revascularization in preventing cardiovascular death or hospitalization due to heart failure.
CLINICALTRIALS.GOV IDENTIFIER: NCT01920048.
METHODS AND RESULTS: The REVIVED-BCIS2 trial randomised 700 participants with ischaemic cardiomyopathy to PCI plus optimal medical therapy (OMT) vs. OMT alone, 263 (37.6%) of whom experienced the primary outcome (all-cause mortality or hospitalization due to heart failure) during a median follow-up of 41 months. Pre-randomization 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 0.66-0.72) and calibration (calibration slope: 0.79, 95% CI 0.64-0.95). 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 hospitalization 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 with participants with higher risk scores.
CONCLUSION: Baseline risk did not influence the effect of revascularization in preventing all-cause mortality or hospitalization due to heart failure. A trend was observed that lower baseline risk might be associated with more benefit of revascularization in preventing cardiovascular death or hospitalization due to heart failure.
CLINICALTRIALS.GOV IDENTIFIER: NCT01920048.