A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.

Dangas GD, Tijssen JGP, Woehrle J, Sondergaard L, Gilard M, Moellmann H, Makkar RR, Herrmann HC, Giustino G, Baldus S, De Backer O, Guimaraes AHC, Gullestad L, Kini A, Von Lewinski D, Mack M, Moreno R, Schaefer U, Seeger J, Tchetche D, Thomitzek K, Valgimigli M, Vranckx P, Welsh RC, Wildgoose P, Volkl AA, Zazula A, Van Amsterdam RGM, Mehran R, Windecker S (2020)

Publication Type: Journal article

Publication year: 2020

Journal

Book Volume: 382

Pages Range: 120-129

Journal Issue: 2

DOI: 10.1056/NEJMoa1911425

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.).

Involved external institutions

Icahn School of Medicine at Mount Sinai United States (USA) (US) University of Amsterdam Netherlands (NL) Universität Ulm Germany (DE) Centre hospitalier universitaire de Brest (CHRU Brest) France (FR) St.-Johannes-Hospital Germany (DE) Cedars-Sinai Medical Center United States (USA) (US) Universitätsklinikum Köln Germany (DE) University of Copenhagen Denmark (DK) Cardialysis Netherlands (NL) Oslo University Hospital / Oslo Universitetssykehus Rikshospitalet Norway (NO) Baylor Scott & White Medical Center - Temple United States (USA) (US) Hospital Universitario La Paz Spain (ES) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Clinique Pasteur France (FR) Bayer HealthCare AG Germany (DE) Universität Bern Switzerland (CH) Hasselt University / Universiteit Hasselt Belgium (BE) University of Alberta Canada (CA) Janssen Global Services, LLC United States (USA) (US) University of Pennsylvania (UPenn) United States (USA) (US)

How to cite

APA:

Dangas, G.D., Tijssen, J.G.P., Woehrle, J., Sondergaard, L., Gilard, M., Moellmann, H.,... Windecker, S. (2020). A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. New England Journal of Medicine, 382(2), 120-129. https://doi.org/10.1056/NEJMoa1911425

MLA:

Dangas, George D., et al. "A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement." New England Journal of Medicine 382.2 (2020): 120-129.

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