A controlled trial of rivaroxaban after transcatheter aortic-valve replacement

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  • George D. Dangas
  • Jan G.P. Tijssen
  • Jochen Wöhrle
  • Søndergaard, Lars
  • Martine Gilard
  • Helge Möllmann
  • Raj R. Makkar
  • Howard C. Herrmann
  • Gennaro Giustino
  • Stephan Baldus
  • De Backer, Ole
  • 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
  • GALILEO Investigators

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.

OriginalsprogEngelsk
TidsskriftNew England Journal of Medicine
Vol/bind382
Udgave nummer2
Sider (fra-til)120-129
Antal sider10
ISSN0028-4793
DOI
StatusUdgivet - 2020

ID: 261164862