Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/175933
Title: A controlled trial of rivaroxaban after transcatheter aortic-valve replacement
Author: Dangas, George D.
Tijssen Jan G.P.
Wöhrle, Jochen
Søndergaard, Lars
Gilard, Martine
Möllmann, Helge
Makkar, Raj R.
Herrmann Howard C.
Giustino, Gennaro
Baldus, Stephan
Backer, Ole de
Guimarães, Ana H.C.
Gullestad, Lars
Kini, Annapoorna
von Lewinski, Dirk
Mack, Michael
Moreno, Raul
Schäfer, Ulrich
Seeger, Julia
Tchétché, Didier
Thomitzek, Karen
Valgimigli, Marco
Vranckx, Pascal
Welsh, Robert C.
Wildgoose, Peter
Volkl, Albert A.
Zazula, Ana
van Amsterdam, Roland G.M.
Mehran, Roxana
Windecker, Stephan
Cequier Fillat, Àngel R.
GALILEO Investigators
Keywords: Aspirina
Ús terapèutic
Catèters
Aspirin
Therapeutic use
Catheters
Issue Date: 9-Jan-2020
Publisher: Massachusetts Medical Society
Abstract: Background: whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. Methods: we randomly assigned 1644 patients without an established indication for oral anticoagulation after successful TAVR to receive rivaroxaban at a dose of 10 mg daily (with aspirin at a dose of 75 to 100 mg daily for the first 3 months) (rivaroxaban group) or aspirin at a dose of 75 to 100 mg daily (with clopidogrel at a dose of 75 mg daily for the first 3 months) (antiplatelet group). The primary efficacy outcome was the composite of death or thromboembolic events. The primary safety outcome was major, disabling, or life-threatening bleeding. The trial was terminated prematurely by the data and safety monitoring board because of safety concerns. Results: after a median of 17 months, death or a first thromboembolic event (intention-to-treat analysis) had occurred in 105 patients in the rivaroxaban group and in 78 patients in the antiplatelet group (incidence rates, 9.8 and 7.2 per 100 person-years, respectively; hazard ratio with rivaroxaban, 1.35; 95% confidence interval [CI], 1.01 to 1.81; P = 0.04). Major, disabling, or life-threatening bleeding (intention-to-treat analysis) had occurred in 46 and 31 patients, respectively (4.3 and 2.8 per 100 person-years; hazard ratio, 1.50; 95% CI, 0.95 to 2.37; P = 0.08). A total of 64 deaths occurred in the rivaroxaban group and 38 in the antiplatelet group (5.8 and 3.4 per 100 person-years, respectively; hazard ratio, 1.69; 95% CI, 1.13 to 2.53). Conclusions: in patients without an established indication for oral anticoagulation after successful TAVR, a treatment strategy including rivaroxaban at a dose of 10 mg daily was associated with a higher risk of death or thromboembolic complications and a higher risk of bleeding than an antiplatelet-based strategy. (Funded by Bayer and Janssen Pharmaceuticals; GALILEO ClinicalTrials.gov number, NCT02556203.).
Note: Reproducció del document publicat a: https://doi.org/10.1056/NEJMoa1911425
It is part of: New England Journal of Medicine, 2020, vol. 382, num. 2, p. 120-129
URI: http://hdl.handle.net/2445/175933
Related resource: https://doi.org/10.1056/NEJMoa1911425
ISSN: 0028-4793
Appears in Collections:Articles publicats en revistes (Ciències Clíniques)

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