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Continuation versus Interruption of Oral Anticoagulation during TAVI
Dirk Jan van Ginkel1, Willem L Bor1, Hugo M Aarts1
1From the Department of Cardiology, St. Antonius Hospital, Nieuwegein (D.J.G., W.L.B., J.P., B.J.W.M.R., L.T., M.J.S., J.B., V.J.N., D.C.O., J.M.B.), the Department of Cardiology, Amsterdam UMC, Amsterdam (H.M.A., J.G.P.T., R.D.), the Department of Cardiology, University Medical Center Utrecht, Utrecht (H.M.A., M. Voskuil), the Department of Cardiology, Radboud University Medical Center, Nijmegen (M.J.P.R., V.J.N., N.R.), the Department of Cardiology, Maastricht University Medical Center (L.V., A.J.J.I., P.A.V., A.W.J.H.), and Cardiovascular Research Institute Maastricht (L.V., P.A.V., A.W.J.H., J.M.B.), Maastricht, the Department of Cardiology, Leiden University Medical Center, Leiden (F.K., J.M.M.-C.), the Department of Cardiology, University Medical Center Groningen, Groningen (K.H.B., J.J.W.), the Department of Cardiology, Erasmus University Medical Center, Rotterdam (N.M.V.M.), the Department of Cardiology, Haga Hospital, the Hague (C.E.S.), the Department of Cardiology, Amphia Hospital, Breda (A.J.J.I., J.H., B.J.L.V.B.), the Department of Cardiology, Isala Hospital, Zwolle (R.S.H., R.L.), and the Department of Cardiology, Elisabeth-Tweesteden Hospital, Tilburg (J.H.) - all in the Netherlands; the Department of Cardiovascular Medicine, University Hospital Leuven, Leuven (C.D., T.A.), the Department of Cardiology, Algemeen Stedelijk Hospital Aalst (L.R.), and Cardiovascular Center Aalst, Onze Lieve Vrouw Hospital (E.B., M. Vanderheyden), Aalst, the Department of Cardiology, Hospital Network Antwerp (ZNA) Middelheim, Antwerp (P.A., H.E.J.), the Department of Cardiology, Sint-Jan Hospital, Bruges (J.A.S.V.D.H.), the Department of Cardiology, AZ Delta, Roeselare (K.D.), and the Department of Cardiology, Hospital Oost-Limburg, Genk (B.F.) - all in Belgium; the Heart Center, Rigshospitalet, Copenhagen University Hospital, Copenhagen (O.D.B., Y.K.); the Department of Clinical and Molecular Medicine, Sapienza University of Rome, Rome (E.B.), and the Cardiothoracovascular Department, University of Trieste, Trieste (E.F.) - both in Italy; the Department of Cardiology, University Hospital Galway, Galway, Ireland (D.M.); and the Department of Cardiology, Institut National de Chirurgie Cardiaque et de Cardiologie Interventionnelle, Luxembourg (P.F., M.L.).
Continuing oral anticoagulation during transcatheter aortic-valve implantation (TAVI) was not found to be noninferior to interruption. Interruption may reduce bleeding risk without increasing thromboembolic events in patients on anticoagulation therapy undergoing TAVI.
Area of Science:
- Cardiology
- Interventional Cardiology
- Anticoagulation Therapy
Background:
- A significant portion of patients undergoing transcatheter aortic-valve implantation (TAVI) require oral anticoagulation due to comorbidities.
- Balancing the risks of bleeding versus thromboembolism during TAVI in these patients is a critical clinical challenge.
Purpose of the Study:
- To evaluate whether continuing oral anticoagulation is noninferior to interrupting it during TAVI.
- To assess the impact of anticoagulation management on key clinical outcomes within 30 days post-TAVI.
Main Methods:
- An international, open-label, randomized, noninferiority trial was conducted.
- 858 patients receiving oral anticoagulants and undergoing TAVI were randomized 1:1 to continue or interrupt anticoagulation.
- The primary outcome was a composite of cardiovascular death, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days.
Main Results:
- The primary composite outcome occurred in 16.5% of the continuation group versus 14.8% in the interruption group (P=0.18 for noninferiority).
- Thromboembolic events were similar between groups (8.8% vs. 8.2%).
- Major bleeding occurred significantly more often in the continuation group (31.1%) compared to the interruption group (21.3%).
Conclusions:
- Periprocedural continuation of oral anticoagulation was not noninferior to interruption for the primary composite outcome in patients undergoing TAVI.
- Interruption of oral anticoagulation may be a safer strategy, showing a lower rate of major bleeding without an increase in thromboembolic events.
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