Pros and cons of PreTAVR PCI, ACTIVATION trial attempts at clearing the confusion
Figure 1. Algorithmic approach for appropriate patient selection for pre-TAVR PCI.
The prevalence of coronary artery disease (CAD) among TAVR recipients is quite high, reaching up to 80%. Percutaneous coronary intervention (PCI) in such patients undergoing TAVR is not without risk, and there are no randomized data to inform clinical practice.
In the latest issue of JACC Cardiovascular Interventions, Patterson et al report the results of the first randomized controlled trial (ACTIVATION trial) designed to compare PCI versus no PCI in TAVR candidates with significant CAD. Observed rates of death and rehospitalization at 1 year were similar between PCI and no PCI prior to TAVR; however, the noninferiority margin was not met, and PCI resulted in a higher incidence of bleeding.
Current American College of Cardiology/American Heart Association guidelines state that PCI is reasonable for critical lesions in proximal coronary vessels, based on limited data, and recommend individualizing treatment. The decision to perform coronary revascularization in TAVR trials is generally left to the operators' discretion, and there is no proof of its appropriateness.
The aim of ACTIVATION trial was to demonstrate the noninferiority of PCI with regard to a composite endpoint of all-cause mortality and rehospitalization at 1 year, with a prespecified noninferiority margin of 7.5%.
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