ACTIVATION (PercutAneous Coronary inTervention prIor to transcatheter aortic VAlve implantaTION): A randomized clinical trial
Journal of the American College of Cardiology Oct 07, 2021
Patterson T, Tim Clayton T, Dod M, et al. - Similar outcomes (rates of death and rehospitalization at 1 year) were evident between percutaneous coronary intervention (PCI) and no PCI prior to transcatheter aortic valve replacement (TAVR) in patients with significant coronary artery disease; but the noninferiority margin was not met, and PCI caused a higher incidence of bleeding.
This study involved severe symptomatic aortic stenosis and significant coronary artery disease cases (n = 235) randomized to PCI or no PCI prior to TAVR.
Occurrence of primary composite endpoint (a composite of all-cause death or rehospitalization at 1 year) in 48 (41.5%) of the PCI arm and 47 (44.0%) of the no-PCI arm was reported.
In the intention-to-treat population, noninferiority testing (prespecified margin of 7.5%) was conducted.
The need for noninferiority was not met (difference: -2.5%; 1-sided upper 95% confidence limit: 8.5%; 1-sided noninferiority test P = 0.067).
Analyzing the as-treated population, the reported difference was -3.7% (1-sided upper 95% confidence limit: 7.5%; P = 0.050).
In PCI and no-PCI arms, mortality was 16 (13.4%) and 14 (12.1%), respectively.
Rates of stroke, myocardial infarction, or acute kidney injury did not differ between arms at 1 year, but there were higher rates of any bleed in the PCI arm.
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