Rationale and design of POPular-TAVI: AntiPlatelet therapy for Patients undergoing Transcatheter Aortic Valve Implantation

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 HuberPieter R. Stella, Jurrien M. Ten Berg

Research output: Contribution to journalArticlepeer-review

51 Scopus citations

Abstract

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 vs aspirin + clopidogrel, and cohort B, patients on OAC therapy are randomized 1:1 to OAC vs OAC + clopidogrel. Primary outcome is freedom from non-procedure-related bleeding at 1 year. Secondary net-clinical benefit outcome is freedom from the composite of cardiovascular death, non-procedural-related bleeding, myocardial infarction, or stroke at 1 year. The primary outcome is analyzed for superiority, whereas the secondary outcome is analyzed for noninferiority. Recruitment began in February 2014, and the trial will continue until a total of 1,000 patients (684 expected in cohort A and 316 in cohort B) are included and followed up for 1 year. Summary The POPular TAVI trial (NCT02247128) is the first large randomized controlled trial to test if monotherapy with aspirin or OAC vs additional clopidogrel after TAVI reduces bleeding with a favorable net-clinical benefit.

Original languageEnglish (US)
Pages (from-to)77-85
Number of pages9
JournalAmerican heart journal
Volume173
DOIs
StatePublished - Mar 1 2016
Externally publishedYes

ASJC Scopus subject areas

  • Cardiology and Cardiovascular Medicine

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