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, Arnoud W J van 't Hof, Niels van Royen, Jan G P Tijssen, Ronak Delewi, Jurriën M Ten Berg
{"title":"Continuation versus Interruption of Oral Anticoagulation during TAVI.","authors":"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, Arnoud W J van 't Hof, Niels van Royen, Jan G P Tijssen, Ronak Delewi, Jurriën M Ten Berg","doi":"10.1056/NEJMoa2407794","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>One 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.</p><p><strong>Methods: </strong>We 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.</p><p><strong>Results: </strong>A 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).</p><p><strong>Conclusions: </strong>In 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.).</p>","PeriodicalId":54725,"journal":{"name":"New England Journal of Medicine","volume":" ","pages":"438-449"},"PeriodicalIF":96.2000,"publicationDate":"2025-01-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"New England Journal of Medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1056/NEJMoa2407794","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/8/31 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"MEDICINE, GENERAL & INTERNAL","Score":null,"Total":0}
引用次数: 0
Abstract
Background: One 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.
Methods: We 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.
Results: A 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).
Conclusions: In 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.).
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