Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
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Dangas, GD; Tijssen, JGP; Wöhrle, J; Søndergaard, L; Gilard, M; Möllmann, H; Makkar, RR; Herrmann, HC; Giustino, G; Baldus, S; De Backer, O; Guimarães, AHC; Gullestad, L; Kini, A; von Lewinski, D; Mack, M; Moreno, R; Schäfer, U; Seeger, J; Tchétché, D; Thomitzek, K; Valgimigli, M; Vranckx, P; Welsh, RC; Wildgoose, P; Volkl, AA; Zazula, A; van Amsterdam, RGM; Mehran, R; Windecker, S; GALILEO Investigators.
A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement.
N Engl J Med. 2020; 382(2):120-129
Doi: 10.1056/NEJMoa1911425
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- Co-Autor*innen der Med Uni Graz
- von Lewinski Dirk
- Study Group Mitglieder der Med Uni Graz:
- Bugger Heiko Matthias
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- Abstract:
- Whether the direct factor Xa inhibitor rivaroxaban can prevent thromboembolic events after transcatheter aortic-valve replacement (TAVR) is unclear. 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. 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). 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.). Copyright © 2019 Massachusetts Medical Society.
- Find related publications in this database (using NLM MeSH Indexing)
- Aged -
- Aged, 80 and over -
- Aspirin - adverse effects
- Aspirin - therapeutic use
- Atrial Fibrillation - drug therapy
- Cardiovascular Diseases - mortality
- Clopidogrel - adverse effects
- Clopidogrel - therapeutic use
- Drug Therapy, Combination -
- Factor Xa Inhibitors - adverse effects
- Factor Xa Inhibitors - therapeutic use
- Female -
- Heart Valve Prosthesis -
- Hemorrhage - chemically induced
- Humans -
- Intention to Treat Analysis -
- Kaplan-Meier Estimate -
- Male -
- Platelet Aggregation Inhibitors - adverse effects
- Platelet Aggregation Inhibitors - therapeutic use
- Rivaroxaban - adverse effects
- Rivaroxaban - therapeutic use
- Thromboembolism - mortality
- Transcatheter Aortic Valve Replacement -