TY - JOUR
T1 - A controlled trial of rivaroxaban after transcatheter aortic-valve replacement
AU - Dangas, George D.
AU - Tijssen, Jan G. P.
AU - Wöhrle, Jochen
AU - Søndergaard, Lars
AU - Gilard, Martine
AU - Möllmann, Helge
AU - Makkar, Raj R.
AU - Herrmann, Howard C.
AU - Giustino, Gennaro
AU - Baldus, Stephan
AU - de Backer, Ole
AU - Guimarães, Ana H. C.
AU - Gullestad, Lars
AU - Kini, Annapoorna
AU - von Lewinski, Dirk
AU - Mack, Michael
AU - Moreno, Raúl
AU - Schäfer, Ulrich
AU - Seeger, Julia
AU - Tchétché, Didier
AU - Thomitzek, Karen
AU - Valgimigli, Marco
AU - Vranckx, Pascal
AU - Welsh, Robert C.
AU - Wildgoose, Peter
AU - Volkl, Albert A.
AU - Zazula, Ana
AU - van Amsterdam, Ronald G. M.
AU - Mehran, Roxana
AU - Windecker, Stephan
AU - GALILEO Investigators
AU - Dangas, G. D.
AU - Windecker, S.
AU - Mehran, R.
AU - Tijssen, J. G. P.
AU - Welsh, R. C.
AU - Vranckx, P.
AU - Valgimigli, M.
AU - van Amsterdam, R. G. M.
AU - Thomitzek, K.
AU - Wildgoose, P.
AU - Colombo, A.
AU - Prendergast, B.
AU - Makkar, R.
AU - Mack, M.
AU - Webb, J.
AU - Marx, Steven O.
AU - Corvaja, Nicola
AU - Ghodsi, Newsha
AU - DiStefano, Douglas
AU - Kaufman, David
N1 - Funding Information: The trial was supported by the sponsors, Bayer and Janssen Pharmaceuticals. The sponsors and the academic investigators designed and supervised the trial, which was executed with the as- sistance of the two clinical research organizations, Cardialysis (Rotterdam, the Netherlands) and the Center for Interventional Cardiovascular Research and Clinical Trials (Mount Sinai Hospital, New York). The executive committee included members of the academic leadership and the sponsors. Data analyses were conducted by DATAN (Havix-beck, Germany). An independent data and safety monitoring board provided oversight by periodically reviewing all reported serious adverse events. The first, second, and last authors wrote the first draft of the manuscript and made the decision to submit it for publication. All the authors reviewed and critiqued subsequent drafts and vouch for the accuracy and completeness of the data and for the fidelity of the trial to the protocol. (Additional information about trial organization is provided in the Supplementary Appendix, available at NEJM.org.) Publisher Copyright: Copyright © 2019 Massachusetts Medical Society. Copyright: Copyright 2020 Elsevier B.V., All rights reserved.
PY - 2020/1/9
Y1 - 2020/1/9
N2 - 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.
AB - 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.
UR - http://www.scopus.com/inward/record.url?scp=85075993796&partnerID=8YFLogxK
U2 - https://doi.org/10.1056/NEJMoa1911425
DO - https://doi.org/10.1056/NEJMoa1911425
M3 - Article
C2 - 31733180
SN - 0028-4793
VL - 382
SP - 120
EP - 129
JO - New England journal of medicine
JF - New England journal of medicine
IS - 2
ER -