• Dirk Jan van Ginkel, Willem L Bor, Hugo M Aarts, Christophe Dubois, Ole De Backer, Maxim J P Rooijakkers, Liesbeth Rosseel, Leo Veenstra, Frank van der Kley, Kees H van Bergeijk, Nicolas M Van Mieghem, Pierfrancesco Agostoni, Michiel Voskuil, Carl E Schotborgh, Alexander J J IJsselmuiden, Jan A S Van Der Heyden, Renicus S Hermanides, Emanuele Barbato, Darren Mylotte, Enrico Fabris, Peter Frambach, Karl Dujardin, Bert Ferdinande, Joyce Peper, Benno J W M Rensing, Leo Timmers, Martin J Swaans, Jorn Brouwer, Vincent J Nijenhuis, Daniel C Overduin, Tom Adriaenssens, Yusuke Kobari, Pieter A Vriesendorp, Jose M Montero-Cabezas, Hicham El Jattari, Jonathan Halim, Ben J L Van den Branden, Remigio Leonora, Marc Vanderheyden, Michael Lauterbach, Joanna J Wykrzykowska, van 't HofArnoud W JAWJ0000-0002-2344-7564From 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., , Niels van Royen, TijssenJan G PJGPFrom 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 Depa, Ronak Delewi, Jurriën M Ten Berg, and POPular PAUSE TAVI Investigators..
• From 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.).
• N. Engl. J. Med. 2024 Aug 31.

BackgroundOne third of patients undergoing transcatheter aortic-valve implantation (TAVI) have an indication for oral anticoagulation owing to concomitant diseases. Interruption of oral anticoagulation during TAVI may decrease the risk of bleeding, whereas continuation may decrease the risk of thromboembolism.MethodsWe conducted an international, open-label, randomized, noninferiority trial involving patients who were receiving oral anticoagulants and were planning to undergo TAVI. Patients were randomly assigned in a 1:1 ratio to periprocedural continuation or interruption of oral anticoagulation. The primary outcome was a composite of death from cardiovascular causes, stroke from any cause, myocardial infarction, major vascular complications, or major bleeding within 30 days after TAVI.ResultsA total of 858 patients were included in the modified intention-to-treat population: 431 were assigned to continuation and 427 to interruption of oral anticoagulation. A primary-outcome event occurred in 71 patients (16.5%) in the continuation group and in 63 (14.8%) in the interruption group (risk difference, 1.7 percentage points; 95% confidence interval [CI], -3.1 to 6.6; P = 0.18 for noninferiority). Thromboembolic events occurred in 38 patients (8.8%) in the continuation group and in 35 (8.2%) in the interruption group (risk difference, 0.6 percentage points; 95% CI, -3.1 to 4.4). Bleeding occurred in 134 patients (31.1%) in the continuation group and in 91 (21.3%) in the interruption group (risk difference, 9.8 percentage points; 95% CI, 3.9 to 15.6).ConclusionsIn patients undergoing TAVI with a concomitant indication for oral anticoagulation, periprocedural continuation was not noninferior to interruption of oral anticoagulation during TAVI with respect to the incidence of a composite of death from cardiovascular causes, stroke, myocardial infarction, major vascular complications, or major bleeding at 30 days. (Funded by the Netherlands Organization for Health Research and Development and the St. Antonius Research Fund; POPular PAUSE TAVI ClinicalTrials.gov number, NCT04437303.).Copyright © 2024 Massachusetts Medical Society.

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