Periprocedural Continuation Versus Interruption of Oral Anticoagulant Drugs During Transcatheter Aortic Valve Implantation (POPular PAUSE TAVI)

Summary

Transcatheter aortic valve implantation (TAVI) is a rapidly growing treatment option for patients with aortic valve stenosis. Stroke is a feared complication of TAVI, with an incidence of around 4-5% in the first 30 days. Up to 50% of patients undergoing TAVI have an indication for oral anticoagulants (OAC) mostly for atrial fibrillation. OAC use during TAVI could increase bleeding complications, but interruption during TAVI may increase the risk for thromboembolic events (i.e. stroke, systemic embolism, myocardial infarction). Recent observational data suggest that periprocedural continuation of OAC is safe and might decrease the risk of stroke. Beside the potential reduction of thromboembolic events, continuation of OAC is associated with an evident clinical ancillary benefit for patients and staff. Since periprocedural OAC interruption not infrequently leads to misunderstanding and potentially dangerous situations, when patients are not properly informed before hospital admission or may experience difficulties with the interruption regimen. Hypothesis: Periprocedural continuation of oral anticoagulants is safe and might decrease thromboembolic complications without an increase in bleeding complications at 30 days

Timeline

Start

2020-11-25

Primary completion

2024-03-21

Completion

2024-05-22

Publications

• van Bergeijk KH, Overduin DC, Venema CS, van Ginkel DJ, van der Werf HW, van den Heuvel AFM, Voors AA, Wykrzykowska JJ, Ten Berg JM. Sex Differences in Transcatheter Aortic Valve Implantation Outcomes in Patients on Oral Anticoagulants: A Popular PAUSE TAVI SubAnalysis. J Am Heart Assoc. 2025 Nov 4;14(21):e043448. doi: 10.1161/JAHA.125.043448. Epub 2025 Oct 23.
• van Ginkel DJ, Bor WL, Aarts HM, Dubois C, De Backer O, Rooijakkers MJP, Rosseel L, Veenstra L, van der Kley F, van Bergeijk KH, Van Mieghem NM, Agostoni P, Voskuil M, Schotborgh CE, IJsselmuiden AJJ, Van Der Heyden JAS, Hermanides RS, Barbato E, Mylotte D, Fabris E, Frambach P, Dujardin K, Ferdinande B, Peper J, Rensing BJWM, Timmers L, Swaans MJ, Brouwer J, Nijenhuis VJ, Overduin DC, Adriaenssens T, Kobari Y, Vriesendorp PA, Montero-Cabezas JM, El Jattari H, Halim J, Van den Branden BJL, Leonora R, Vanderheyden M, Lauterbach M, Wykrzykowska JJ, van 't Hof AWJ, van Royen N, Tijssen JGP, Delewi R, Ten Berg JM; POPular PAUSE TAVI Investigators.; POPular PAUSE TAVI Investigators. Continuation versus Interruption of Oral Anticoagulation during TAVI. N Engl J Med. 2025 Jan 30;392(5):438-449. doi: 10.1056/NEJMoa2407794. Epub 2024 Aug 31.

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