EuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology · 2023
Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод пока не подготовлен
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van Ginkel Dirk Jan, Bor Willem L, Dubois Christophe L F, Aarts Hugo M, Rooijakkers Maxim J P, van Bergeijk Kees H, Rosseel Liesbeth, Veenstra Leo, De Backer Ole, Van Mieghem Nicolas M, van der Kley Frank, Wilgenhof Adriaan, Leonora Remigio, Halim Jonathan, Schotborgh Carl E, Barbato Emanuele, Van Der Heyden Jan A S, Frambach Peter, Ferdinande Bert, Mylotte Darren, Fabris Enrico, Rensing Benno J W M, Timmers Leo, Swaans Martin J, Brouwer Jorn, Nijenhuis Vincent J, Peper Joyce, Vriesendorp Pieter A, de Laat Bas, Ninivaggi Marisa, Stragier Hendrik, Voskuil Michiel, IJsselmuiden Alexander J J, Hermanides Renicus S, Agostoni Pierfrancesco, van 't Hof Arnoud W J, Wykrzykowska Joanna J, van Royen Niels, Delewi Ronak, Ten Berg Jurrien M
Аннотация
About one-third of patients undergoing transcatheter aortic valve implantation (TAVI) use oral anticoagulants (OAC), mainly due to atrial fibrillation. General guidelines advise interrupting OAC in patients with a high risk of bleeding undergoing interventions. However, preliminary observational data suggest that the continuation of OAC during TAVI is safe and may reduce the risk of periprocedural thromboembolic events. The Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI) is a multicentre, randomised clinical trial with open-label treatment and blinded endpoint assessment. Patients are randomised 1:1 to periprocedural continuation versus interruption of OAC and are stratified for vitamin K antagonist or direct oral anticoagulant use. The primary endpoint is a composite of cardiovascular mortality, all stroke, myocardial infarction, major vascular complications and type 2-4 bleeding within 30 days after TAVI, according to the Valve Academic Research Consortium-3 criteria. Secondary endpoints include separate individual and composite outcomes, quality of life and cost-effectiveness. Since continuation of OAC is associated with the ancillary benefit that it simplifies periprocedural management, the primary outcome is first analysed for non-inferiority; if non-inferiority is proven, superiority will be tested. Recruitment started in November 2020, and the trial will continue until a total of 858 patients have been included and followed for 90 days. In summary, POPular PAUSE TAVI is the first randomised clinical trial to assess the safety and efficacy of periprocedural continuation versus interruption of OAC in patients undergoing TAVI.