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 Mylotte; Enrico 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

doi:10.4244/EIJ-D-23-00206

The Official Journal of EuroPCR and the European Association of Percutaneous Cardiovascular Interventions (EAPCI)

The reference multimedia journal in interventional cardiology

Trial design

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 Ginkel¹, MD; Willem L. Bor¹, MD; Christophe L.F. Dubois², MD, PhD; Hugo M. Aarts³^,⁴, MD; Maxim J.P. Rooijakkers⁵, MD; Kees H. van Bergeijk⁶, MD; Liesbeth Rosseel⁷, MD, PhD; Leo Veenstra⁸, MD; Ole De Backer⁹, MD, PhD; Nicolas M. Van Mieghem¹⁰, MD, PhD; Frank van der Kley¹¹, MD, PhD; Adriaan Wilgenhof³^,¹², MD; Remigio Leonora¹³, MD; Jonathan Halim¹⁴, MD; Carl E. Schotborgh¹⁵, MD, PhD; Emanuele Barbato¹⁶, MD, PhD; Jan A.S. Van Der Heyden¹⁷, MD, PhD; Peter Frambach¹⁸, MD, PhD; Bert Ferdinande¹⁹, MD, PhD; Darren Mylotte²⁰, MD, PhD; Enrico Fabris²¹, MD, PhD; Benno J.W.M. Rensing¹, MD, PhD; Leo Timmers¹, MD, PhD; Martin J. Swaans¹, MD, PhD; Jorn Brouwer¹, MD, PhD; Vincent J. Nijenhuis¹, MD, PhD; Joyce Peper¹, MSc, PhD; Pieter A. Vriesendorp⁸, MD, PhD; Bas de Laat²², MSc, PhD; Marisa Ninivaggi²², MSc, PhD; Hendrik Stragier²³^,²⁴, MD; Michiel Voskuil⁴, MD, PhD; Alexander J.J. IJsselmuiden¹⁴, MD, PhD; Renicus S. Hermanides¹¹, MD, PhD; Pierfrancesco Agostoni¹¹, MD, PhD; Arnoud W.J. van 't Hof⁸^,²⁴, MD, PhD; Joanna J. Wykrzykowska⁶, MD, PhD; Niels van Royen⁵, MD, PhD; Ronak Delewi³, MD, PhD; Jurrien M. ten Berg¹^,²⁴, MD, PhD

1. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; 2. Department of Cardiovascular Medicine, University Hospital Leuven, Leuven, Belgium; 3. Department of Cardiology, Amsterdam UMC, Amsterdam, the Netherlands; 4. Department of Cardiology, University Medical Center Utrecht, Utrecht, the Netherlands; 5. Department of Cardiology, Radboud University Medical Center, Nijmegen, the Netherlands; 6. Department of Cardiology, University Medical Center Groningen, Groningen, the Netherlands; 7. Department of Cardiology, Algemeen Stedelijk Hospital Aalst, Aalst, Belgium; 8. Department of Cardiology, Maastricht University Medical Center, Maastricht, the Netherlands; 9. The Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark; 10. Department of Cardiology, Erasmus University Medical Center, Rotterdam, the Netherlands; 11. Department of Cardiology, Leiden University Medical Center, Leiden, the Netherlands; 12. Department of Cardiology, Hospital Network Antwerp (ZNA) Middelheim, Antwerp, Belgium; 13. Department of Cardiology, Isala Hospital, Zwolle, the Netherlands; 14. Department of Cardiology, Amphia Hospital, Breda, the Netherlands; 15. Department of Cardiology, Haga Hospital, The Hague, the Netherlands; 16. Cardiovascular Center Aalst, Onze Lieve Vrouwe Hospital, Aalst, the Netherlands; 17. Department of Cardiology, Sint-Jan Hospital, Brugge, Belgium; 18. Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg City, Luxembourg; 19. Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium; 20. Department of Cardiology, University Hospital Galway, Galway, Ireland; 21. Cardiothoracovascular Department, University of Trieste, Trieste, Italy; 22. Department of Functional Coagulation, Synapse Research Institute, Maastricht, the Netherlands; 23. Department of Anesthesiology, Intensive Care Medicine, Emergency Medicine and Pain Therapy, Hospital Oost-Limburg, Genk, Belgium; 24. Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands

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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