Rationale and design of POPular-TAVI: antiPlatelet therapy fOr Patients undergoing Transcatheter Aortic Valve Implantation

Publication date: Available online 1 December 2015 Source:American Heart Journal Author(s): Vincent Johan Nijenhuis, Naoual Bennaghmouch, Mariella Hassell, Jan Baan, Jan Peter van Kuijk, Pierfrancesco Agostoni, Arnoud van ‘t Hof, Peter C. Kievit, Leo Veenstra, Pim van der Harst, Ad F.M. van den Heuvel, Peter den Heijer, Johannes C. Kelder, Vera H. Deneer, Frank van der Kley, Francesco Onorati, Jean Philippe Collet, Francesco Maisano, Azeem Latib, Kurt Huber, Pieter R. Stella, Jurrien M. ten Berg Background Despite improving experience and techniques, ischemic and bleeding complications after Transcatheter Aortic Valve Implantation (TAVI) remain prevalent and impair survival. Current guidelines recommend the temporary addition of clopidogrel in the initial period after TAVI to prevent thromboembolic events. However, explorative studies suggest that this is associated with a higher rate of major bleeding without a decrease in thromboembolic complications. Methods The POPular TAVI trial is a prospective randomized controlled open-label multicenter clinical trial to test the hypothesis that monotherapy with aspirin or oral anticoagulation (OAC) after TAVI is safer than the addition of clopidogrel for 3 months, without compromising clinical benefit. This trial encompasses 2 cohorts: cohort A, patients are randomized 1:1 to aspirin versus aspirin + clopidogrel; and cohort B, patients on OAC therapy are randomized 1:1 to OAC ve...
Source: American Heart Journal - Category: Cardiology Source Type: research