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

Factor Xa Inhibitors; Platelet Aggregation Inhibitors; 9NDF7JZ4M3 (Rivaroxaban); A74586SNO7 (Clopidogrel); R16CO5Y76E (Aspirin); Aged; Aged, 80 and over; Aspirin/adverse effects/therapeutic use; Atrial Fibrillation/drug therapy; Cardiovascular Diseases/mortality; Clopidogrel/adverse effects/therapeutic use; Drug Therapy, Combination; Factor Xa Inhibitors/adverse effects/therapeutic use; Female; Heart Valve Prosthesis; Hemorrhage/chemically induced; Humans; Intention to Treat Analysis; Kaplan-Meier Estimate; Male; Platelet Aggregation Inhibitors/adverse effects/therapeutic use; Rivaroxaban/adverse effects/therapeutic use; Thromboembolism/mortality; Transcatheter Aortic Valve Replacement

Abstract :

[en] 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.).

Disciplines :

Cardiovascular & respiratory systems

Author, co-author :

Dangas, George D; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Tijssen, Jan G P; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Wöhrle, Jochen; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Søndergaard, Lars; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Gilard, Martine; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Möllmann, Helge; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Makkar, Raj R; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Herrmann, Howard C; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Giustino, Gennaro; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

Baldus, Stephan; From the Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of

More authors (21 more)

Other collaborator :

Dangas, G D

Windecker, S

Mehran, R

Tijssen, J G P

Welsh, R C

Vranckx, P

Valgimigli, M

van Amsterdam, R G M

Thomitzek, K

Wildgoose, P

More authors (717 more)

Language :

English

Title :

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

Publication date :

09 January 2020

Journal title :

New England Journal of Medicine

ISSN :

0028-4793

eISSN :

1533-4406

Publisher :

Massachusetts Medical Society, Us ma

Volume :

382

Issue :

Pages :

120-129

Peer reviewed :

Peer Reviewed verified by ORBi

Funding number :

Sponsor/Bayer/International; Sponsor/Janssen Pharmaceuticals/International

Commentary :

Available on ORBi :

since 18 May 2022

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