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Randomized Controlled Trial
. 2023 Nov 17;19(9):766-771.
doi: 10.4244/EIJ-D-23-00206.

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  1 , Willem L Bor  1 , Christophe L F Dubois  2 , Hugo M Aarts  3   4 , Maxim J P Rooijakkers  5 , Kees H van Bergeijk  6 , Liesbeth Rosseel  7 , Leo Veenstra  8 , Ole De Backer  9 , Nicolas M Van Mieghem  10 , Frank van der Kley  11 , Adriaan Wilgenhof  3   12 , Remigio Leonora  13 , Jonathan Halim  14 , Carl E Schotborgh  15 , Emanuele Barbato  16 , Jan A S Van Der Heyden  17 , Peter Frambach  18 , Bert Ferdinande  19 , Darren Mylotte  20 , Enrico Fabris  21 , Benno J W M Rensing  1 , Leo Timmers  1 , Martin J Swaans  1 , Jorn Brouwer  1 , Vincent J Nijenhuis  1 , Joyce Peper  1 , Pieter A Vriesendorp  8 , Bas de Laat  22 , Marisa Ninivaggi  22 , Hendrik Stragier  23   24 , Michiel Voskuil  4 , Alexander J J IJsselmuiden  14 , Renicus S Hermanides  11 , Pierfrancesco Agostoni  11 , Arnoud W J van 't Hof  8   24 , Joanna J Wykrzykowska  6 , Niels van Royen  5 , Ronak Delewi  3 , Jurrien M Ten Berg  1   24
Affiliations
Randomized Controlled Trial

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 et al. EuroIntervention. .

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.

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Conflict of interest statement

The authors have no conflicts of interest to declare with respect to this manuscript.

Figures

Figure 1
Figure 1. Flowchart for the POPular PAUSE TAVI trial.
AF: atrial fibrillation; KCCQ: Kansas City Cardiomyopathy Questionnaire; OAC: oral anticoagulation; SF-12: Short Form-12; TASQ: Toronto Aortic Stenosis Questionnaire. TAVI: transcatheter aortic valve implantation; TIA: transient ischaemic attack; VARC: Valve Academic Research Consortium
See this image and copyright information in PMC

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