Periprocedural continuation versus interruption of oral anticoagulant drugs during transcatheter aortic valve implantation: rationale and design of the POPular PAUSE TAVI trial

Dirk-Jan van Ginkel, Willem L Bor, Christophe L F Dubois, Hugo M Aarts, Maxim J P Rooijakkers, Kees H van Bergeijk, Liesbeth Rosseel, Leo Veenstra, Ole De Backer, Nicolas M Van Mieghem, Frank van der Kley, Adriaan Wilgenhof, Remigio Leonora, Jonathan Halim, Carl E Schotborgh, Emanuele Barbato, Jan A S Van Der Heyden, Peter Frambach, Bert Ferdinande, Darren MylotteEnrico Fabris, Benno J W M Rensing, Leo Timmers, Martin J Swaans, Jorn Brouwer, Vincent J Nijenhuis, Joyce Peper, Pieter A Vriesendorp, Bas de Laat, Marisa Ninivaggi, Hendrik Stragier, Michiel Voskuil, Alexander J J IJsselmuiden, Renicus S Hermanides, Pierfrancesco Agostoni, Arnoud W J van 't Hof, Joanna J Wykrzykowska, Niels van Royen, Ronak Delewi, Jurrien M Ten Berg

1 Citationer (Scopus)

Abstract

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.

OriginalsprogEngelsk
TidsskriftEuroIntervention : journal of EuroPCR in collaboration with the Working Group on Interventional Cardiology of the European Society of Cardiology
Vol/bind19
Udgave nummer9
Sider (fra-til)766-771
Antal sider6
ISSN1774-024X
DOI
StatusUdgivet - 17 nov. 2023

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