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

Dangas, George D; Tijssen, Jan G P; Wöhrle, Jochen; Søndergaard, Lars; Gilard, Martine; Möllmann, Helge; Makkar, Raj R; Herrmann, Howard C; Giustino, Gennaro; Baldus, Stephan; De Backer, Ole; Guimarães, Ana H C; Gullestad, Lars; Kini, Annapoorna; von Lewinski, Dirk; Mack, Michael; Moreno, Raúl; Schäfer, Ulrich; Seeger, Julia; Tchétché, Didier; ... (2020). A Controlled Trial of Rivaroxaban after Transcatheter Aortic-Valve Replacement. The New England journal of medicine, 382(2), pp. 120-129. Massachusetts Medical Society 10.1056/NEJMoa1911425

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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.).

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