Ashley Verburg; Wilbert  L. Bor; I. Tarik Küçük; José  P.S. Henriques; Maarten  A. Vink; Willem-Peter  T. Ruifrok; Jacobus Plomp; Ton  A.C.M. Heestermans; Carl  E. Schotborgh; Pieter  J. Vlaar; Michael Magro; Sem  A.O.F. Rikken; Wout  W.A. van den Broek; Carlos  A.G. van Mieghem; Kristoff Cornelis; Liesbeth Rosseel; Karl  S. Dujardin; Bert Vandeloo; Tom Vandendriessche; Bert Ferdinande; Arnoud  W.J. van ’t Hof; Jan  G.P. Tijssen; Ugo Limbruno; Raffaele De Caterina; Andrea Rubboli; Dominick  J. Angiolillo; Tom Adriaenssens; Willem Dewilde; Jurrien  M. ten Berg

doi:10.4244/EIJ-D-24-00100

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-24-00100

Temporary omission of oral anticoagulation in atrial fibrillation patients undergoing percutaneous coronary intervention: rationale and design of the WOEST-3 randomised trial

Ashley Verburg¹^,², MD; Wilbert L. Bor¹, MD; I. Tarik Küçük³, MD; José P.S. Henriques³, MD, PhD; Maarten A. Vink⁴, MD, PhD; Willem-Peter T. Ruifrok⁵, MD, PhD; Jacobus Plomp⁶, MD; Ton A.C.M. Heestermans⁷, MD, PhD; Carl E. Schotborgh⁸, MD; Pieter J. Vlaar⁹, MD, PhD; Michael Magro¹⁰, MD, PhD; Sem A.O.F. Rikken¹^,², MD; Wout W.A. van den Broek¹, MD; Carlos A.G. van Mieghem¹¹, MD, PhD; Kristoff Cornelis¹², MD; Liesbeth Rosseel¹³, MD; Karl S. Dujardin¹⁴, MD; Bert Vandeloo¹⁵, MD; Tom Vandendriessche¹⁶, MD; Bert Ferdinande¹⁷, MD; Arnoud W.J. van ’t Hof¹⁸^,¹⁹, MD, PhD; Jan G.P. Tijssen²⁰, PhD; Ugo Limbruno²¹, MD, PhD; Raffaele De Caterina²²^,²³, MD, PhD; Andrea Rubboli²⁴, MD; Dominick J. Angiolillo²⁵, MD, PhD; Tom Adriaenssens²⁶, MD, PhD; Willem Dewilde²⁷, MD, PhD; Jurrien M. ten Berg¹^,¹⁸, MD, PhD

1. Department of Cardiology, St. Antonius Hospital, Nieuwegein, the Netherlands; 2. Cardiovascular Research Institute Maastricht (CARIM), Maastricht, the Netherlands; 3. Department of Cardiology, Amsterdam Cardiovascular Sciences, Amsterdam UMC, University of Amsterdam, Amsterdam, the Netherlands; 4. Department of Cardiology, OLVG, Amsterdam, the Netherlands; 5. Department of Cardiology, Treant Zorggroep, Emmen, the Netherlands; 6. Department of Cardiology, Tergooi MC, Blaricum, the Netherlands; 7. Department of Cardiology, Noordwest Ziekenhuisgroep, Alkmaar, the Netherlands; 8. Department of Cardiology, Haga Hospital, Den Haag, the Netherlands; 9. Department of Cardiology, Catharina Hospital, Eindhoven, the Netherlands; 10. Department of Cardiology, Elisabeth-TweeSteden Hospital, Tilburg, the Netherlands; 11. Department of Cardiology, AZ Groeninge, Kortrijk, Belgium; 12. Department of Cardiology, AZ Maria Middelares, Gent, Belgium; 13. Department of Cardiology, Algemeen Stedelijk Hospital, Aalst, Belgium; 14. Department of Cardiology, AZ Delta, Roeselare, Belgium; 15. Department of Cardiology, University Hospital Brussels, Brussels, Belgium; 16. Department of Cardiology, University Hospital Antwerpen, Antwerpen, Belgium; 17. Department of Cardiology, Hospital Oost-Limburg, Genk, Belgium; 18. Department of Cardiology, University Medical Centre Maastricht, Maastricht, the Netherlands; 19. Department of Cardiology, Zuyderland Medical Centre, Heerlen, the Netherlands; 20. Department of Clinical Epidemiology and Biostatistics, Amsterdam UMC, Amsterdam, the Netherlands; 21. Cardioneurovascular Department, Azienda USL Toscana Sud Est, Grosseto, Italy; 22. Cardio-Thoracic and Vascular Department, Pisa University Hospital, Pisa, Italy and University of Pisa, Pisa, Italy; 23. Fondazione Villaserena per la Ricerca, Città Sant’Angelo, Italy; 24. Department of Cardiology, Ospedale S. Maria delle Croci, Ravenna, Italy; 25. Division of Cardiology, University of Florida College of Medicine, Jacksonville, FL, USA; 26. Department of Cardiology, University Hospitals Leuven, Leuven, Belgium; 27. Department of Cardiology, Imelda Hospital, Bonheiden, Belgium

Abstract

The optimal antithrombotic management of atrial fibrillation (AF) patients who require oral anticoagulation (OAC) undergoing percutaneous coronary intervention (PCI) remains unclear. Current guidelines recommend dual antithrombotic therapy (DAT; OAC plus P2Y12 inhibitor – preferably clopidogrel) after a short course of triple antithrombotic therapy (TAT; DAT plus aspirin). Although DAT reduces bleeding risk compared to TAT, this is counterbalanced by an increase in ischaemic events. Aspirin provides early ischaemic benefit, but TAT is associated with an increased haemorrhagic burden; therefore, we propose a 30-day dual antiplatelet therapy (DAPT; aspirin plus P2Y12 inhibitor) strategy post-PCI, temporarily omitting OAC. The study aims to compare bleeding and ischaemic risk between a 30-day DAPT strategy following PCI and a guideline-directed therapy in AF patients requiring OAC. WOEST-3 (ClinicalTrials.gov: NCT04436978) is an investigator-initiated, international, open-label, randomised controlled trial (RCT). AF patients requiring OAC who have undergone successful PCI will be randomised within 72 hours after PCI to guideline-directed therapy (edoxaban plus P2Y12 inhibitor plus limited duration of aspirin) or a 30-day DAPT strategy (P2Y12 inhibitor plus aspirin, immediately discontinuing OAC) followed by DAT (edoxaban...

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