A controlled trial of rivaroxaban after transcatheter aortic-valve replacement

George D. Dangas, Jan G.P. Tijssen, Jochen Wöhrle, Lars Søndergaard, Martine Gilard, Helge Möllmann, Raj R. Makkar, Howard C. Herrmann, Gennaro Giustino, Stephan Baldus, Ole de Backer, Ana H.C. Guimarães, Lars Gullestad, Annapoorna Kini, Dirk von Lewinski, Michael Mack, Raúl Moreno, Ulrich Schäfer, Julia Seeger, Didier TchétchéKaren Thomitzek, Marco Valgimigli, Pascal Vranckx, Robert C. Welsh, Peter Wildgoose, Albert A. Volkl, Ana Zazula, Ronald G.M. van Amsterdam, Roxana Mehran, Stephan Windecker*, GALILEO Investigators

*Corresponding author for this work

Research output: Contribution to journalJournal articleResearchpeer-review

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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.

Original languageEnglish
JournalNew England Journal of Medicine
Volume382
Issue number2
Pages (from-to)120-129
Number of pages10
ISSN0028-4793
DOIs
Publication statusPublished - 2020

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