Your browser doesn't support javascript.
loading
Continuation versus Interruption of Oral Anticoagulation during TAVI.
van Ginkel, Dirk Jan; Bor, Willem L; Aarts, Hugo M; Dubois, Christophe; De Backer, Ole; Rooijakkers, Maxim J P; Rosseel, Liesbeth; Veenstra, Leo; van der Kley, Frank; van Bergeijk, Kees H; Van Mieghem, Nicolas M; Agostoni, Pierfrancesco; Voskuil, Michiel; Schotborgh, Carl E; IJsselmuiden, Alexander J J; Van Der Heyden, Jan A S; Hermanides, Renicus S; Barbato, Emanuele; Mylotte, Darren; Fabris, Enrico; Frambach, Peter; Dujardin, Karl; Ferdinande, Bert; Peper, Joyce; Rensing, Benno J W M; Timmers, Leo; Swaans, Martin J; Brouwer, Jorn; Nijenhuis, Vincent J; Overduin, Daniel C; Adriaenssens, Tom; Kobari, Yusuke; Vriesendorp, Pieter A; Montero-Cabezas, Jose M; El Jattari, Hicham; Halim, Jonathan; Van den Branden, Ben J L; Leonora, Remigio; Vanderheyden, Marc; Lauterbach, Michael; Wykrzykowska, Joanna J; van 't Hof, Arnoud W J; van Royen, Niels; Tijssen, Jan G P; Delewi, Ronak; Ten Berg, Jurriën M.
Afiliação
  • van Ginkel DJ; 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, Utrec
  • Bor WL; 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, Utrec
  • Aarts HM; 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, Utrec
  • Dubois C; 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, Utrec
  • De Backer O; 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, Utrec
  • Rooijakkers MJP; 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, Utrec
  • Rosseel L; 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, Utrec
  • Veenstra L; 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, Utrec
  • van der Kley F; 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, Utrec
  • van Bergeijk KH; 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, Utrec
  • Van Mieghem NM; 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, Utrec
  • Agostoni P; 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, Utrec
  • Voskuil M; 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, Utrec
  • Schotborgh CE; 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, Utrec
  • IJsselmuiden AJJ; 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, Utrec
  • Van Der Heyden JAS; 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, Utrec
  • Hermanides RS; 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, Utrec
  • Barbato E; 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, Utrec
  • Mylotte D; 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, Utrec
  • Fabris E; 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, Utrec
  • Frambach P; 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, Utrec
  • Dujardin K; 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, Utrec
  • Ferdinande B; 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, Utrec
  • Peper J; 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, Utrec
  • Rensing BJWM; 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, Utrec
  • Timmers L; 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, Utrec
  • Swaans MJ; 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, Utrec
  • Brouwer J; 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, Utrec
  • Nijenhuis VJ; 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, Utrec
  • Overduin DC; 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, Utrec
  • Adriaenssens T; 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, Utrec
  • Kobari Y; 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, Utrec
  • Vriesendorp PA; 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, Utrec
  • Montero-Cabezas JM; 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, Utrec
  • El Jattari H; 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, Utrec
  • Halim J; 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, Utrec
  • Van den Branden BJL; 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, Utrec
  • Leonora R; 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, Utrec
  • Vanderheyden M; 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, Utrec
  • Lauterbach M; 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, Utrec
  • Wykrzykowska JJ; 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, Utrec
  • van 't Hof AWJ; 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, Utrec
  • van Royen N; 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, Utrec
  • Tijssen JGP; 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, Utrec
  • Delewi R; 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, Utrec
  • Ten Berg JM; 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, Utrec
N Engl J Med ; 2024 Aug 31.
Article em En | MEDLINE | ID: mdl-39216096
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 11 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.).

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: N Engl J Med Ano de publicação: 2024 Tipo de documento: Article País de publicação: Estados Unidos

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Idioma: En Revista: N Engl J Med Ano de publicação: 2024 Tipo de documento: Article País de publicação: Estados Unidos