Deferral of routine percutaneous coronary intervention in patients undergoing transcatheter aortic valve implantation: Rationale and design of the PRO-TAVI trial

Abstract

Background: Concomitant coronary artery disease (CAD) is highly prevalent in patients with severe aortic stenosis undergoing transcatheter aortic valve implantation (TAVI). The optimal treatment strategy for CAD is a topic of debate. An initial conservative strategy for CAD in patients undergoing TAVI may be favorable as multiple studies have failed to show an evident beneficial effect of percutaneous coronary intervention (PCI) on mortality after TAVI. However, more randomized, controlled trials are warranted. Methods: The PeRcutaneous cOronary Intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is an investigator-initiated, multicenter, open-label, randomized controlled trial comparing TAVI with or without routine preprocedural PCI. A total of 466 patients undergoing TAVI will be randomized in a 1:1 ratio to PCI (reference group) or no PCI (index group). Concomitant CAD is defined as at least 1 stenosis of 70% to 99%, or at least 1 stenosis between 40% and 70% combined with positive physiological measurement in a coronary artery with a minimal diameter of 2.5 mm or bypass graft. The primary endpoint is a composite of all-cause mortality, myocardial infarction, stroke, or type 2 - 4 bleeding at 12 months after randomization, in accordance with Valve Academic Research Consortium-3 criteria. Key secondary endpoints include the individual components of the primary endpoint, revascularization, quality of life and cost-effectiveness. The primary endpoint will be analyzed to assess non-inferiority of deferral of routine PCI in patients undergoing TAVI against the prespecified margin of 11 percentage points. Conclusion: The PeRcutaneous cOronary intervention before Transcatheter Aortic Valve Implantation (PRO-TAVI) trial is designed to investigate the hypothesis that deferral of routine PCI in patients undergoing TAVI is non-inferior to TAVI with preceding PCI. Clinical trial registration: clinicaltrials.gov.