• George D Dangas, Tijssen Jan G P JGP From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); Natio, 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 Tchétché, Karen Thomitzek, Marco Valgimigli, Pascal Vranckx, Robert C Welsh, Peter Wildgoose, Albert A Volkl, Ana Zazula, Ronald G M van Amsterdam, Roxana Mehran, Stephan Windecker, and GALILEO Investigators.
• From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York (G.D.D., G.G., A.K., R. Mehran); National and Kapodistrian University of Athens, Athens (G.D.D.); Amsterdam University Medical Centers-University of Amsterdam, Amsterdam (J.G.P.T.), and Cardialysis, Academic Research Organization, Rotterdam (J.G.P.T., A.H.C.G., R.G.M.A.) - both in the Netherlands; the Department of Internal Medicine II, University of Ulm, Ulm (J.W., J.S.), the Department of Internal Medicine I, St. Johannes Hospital Dortmund, Dortmund (H.M.), the Department of Internal Medicine III, Heart Center, University Hospital of Cologne, Cologne (S.B.), the Department of General and Interventional Cardiology, University Hospital Hamburg-Eppendorf, Hamburg (U.S.), and Bayer, Berlin (K.T.) - all in Germany; the Heart Center, Rigshospitalet, University of Copenhagen, Copenhagen (L.S., O.D.B.); La Cavale Blanche University Hospital, Cardiology Department, Brest (M.G.), and Clinique Pasteur, Toulouse (D.T.) - both in France; Smidt Heart Institute, Cedars-Sinai Medical Center, Los Angeles (R.R.M.); the University of Pennsylvania, Philadelphia (H.C.H.); the Department of Cardiology, Oslo University Hospital Rikshospitalet, and the Institute of Clinical Medicine, University of Oslo - all in Oslo (L.G.); the Department of Cardiology, Medical University of Graz, Graz, Austria (D.L.); Baylor Scott and White Health, Temple, TX (M.M.); the Department of Cardiology, University Hospital of La Paz, Hospital La Paz Institute for Health Research, Madrid (R. Moreno); the Department of Cardiology, Inselspital, Bern University Hospital, University of Bern, Bern, Switzerland (M.V., S.W.); the Department of Cardiology and Critical Care Medicine, Hartcentrum Hasselt, and Faculty of Medicine and Life Sciences, University of Hasselt - all in Hasselt, Belgium (P.V.); Mazankowski Alberta Heart Institute, University of Alberta, Edmonton, Canada (R.C.W.); Janssen Pharmaceuticals, Titusville, NJ (P.W., A.A.V.); and Bayer, São Paulo (A.Z.).
• N. Engl. J. Med. 2020 Jan 9; 382 (2): 120-129.

BackgroundWhether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear.MethodsWe 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.ResultsAfter 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).ConclusionsIn 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.).Copyright © 2019 Massachusetts Medical Society.

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