PCI prior to TAVR may not reduce mortality or re-hospitalization: ACTIVATION trial
Delhi: Pre-procedure PCI versus no PCI in patients undergoing TAVR having significant coronary artery disease (CAD) did not result in better chances of survival or decrease in re-hospitalization risk, reveals findings from ACTIVATION Trial. The findings of the study were presented at the PCR Valves e-Course 2020 by Simon Redwood, from King's College London, England.
ACTIVATION is the first randomized trial of percutaneous coronary intervention (PCI) versus no PCI in patients with severe aortic stenosis and CAD undergoing transcatheter aortic valve replacement (TAVR). The trial found no difference in one-year mortality or rehospitalisation from PCI prior to TAVR.
The trial was conducted across 17 sites in the UK, Germany, and France. It enrolled patients having severe, symptomatic aortic stenosis as well as at least one proximal stenosis of > 70% in a major epicardial coronary artery, suitable for PCI. More than two thirds of patients had single-vessel disease and most of the rest had two-vessel CAD. It excluded patients with active bleeds, left main disease, a recent ACS, or class III-IV angina. Enrollment was done from late 2012 until January 2019 when pratice changes the facility -- total trial participation at 235 was shy of the 310 originally planned for the study.
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