Rivaroxaban was shown to be more effective than enoxaparin in preventing major venous thromboembolic events after nonmajor orthopedic surgery of the lower limbs, according to late-breaking trial results presented Sunday at the American College of Cardiology Scientific Sessions 2020 virtual conference.
Nadia Rosencher, MD, of University Hospital of Saint-Etienne, France, presented results of PRONOMOS (PROphylaxis in Non-major Orthopedic Surgery), a multicenter, randomized trial.
After non-major orthopedic surgery of the lower limbs, patients are at risk of developing venous thromboembolism (VTE) because of reduced mobility. The PRONOMOS trial was an international randomized, double-blind study that tested the hypothesis that rivaroxaban was noninferior to enoxaparin to prevent major VTE in these patients.
The primary efficacy endpoint was a test for noninferiority for the composite of symptomatic distal or proximal deep vein thrombosis (DVT), pulmonary embolism (PE) or VTE-related death during the treatment or asymptomatic proximal DVT at the end of treatment. According to the study design, if non-inferiority was met, an analysis for superiority was performed. Prespecified secondary outcomes were major and clinically relevant nonmajor bleeding, overt thrombocytopenia and all-cause death.
A total of 3,604 patients were randomized, 1,809 received rivaroxaban and 1,795 received enoxaparin after undergoing surgery. The primary efficacy endpoint was superior in patients given rivaroxaban in comparison with those given enoxaparin (risk ratio, 0.25; 95% confidence interval, 0.009-0.75; p-superiority=0.01). Neither major nor nonmajor bleeding rates differed between the groups (major bleeding: rivaroxaban 1.08% vs. enoxaparin 1.04%).
Rosencher concluded that rivaroxaban was effective in preventing major venous thromboembolic events after nonmajor orthopedic surgery of the lower limbs. The results were simultaneously published online in The New England Journal of Medicine.
The trial was supported by Centre Hospitalier Universitaire de Saint-Etienne, France, and Bayer.