Study: Rivaroxaban Reduces Risk of Major Venous Thromboembolism Following Nonmajor Orthopedic Surgery

Data from a study of 3604 adults who underwent nonmajor orthopedic surgery show that rivaroxaban (Xarelto, Janssen) reduced the risk of major venous thromboembolism (VTE) by approximately 75% compared with enoxaparin.

Rivaroxaban is a non-vitamin K antagonist oral anticoagulant that is broadly indicated worldwide, according to a press release from Bayer.

“Nonmajor orthopedic surgery of the lower limbs—like ligament repair of the knee or ankle fracture—can result in a temporary reduction in mobility, placing patients at risk of developing a VTE,” said Nadia Rosencher, MD, an investigator in the Pronomos study in a statement. “Today, there are limited effective prophylactic treatment options available.”

Pronomos was an international multi-center, randomized, double-blind study in which 3604 patients underwent surgery of the lower limbs and required thromboprophylaxis for at least 2 weeks. In the study, 1809 patients were assigned to receive rivaroxaban 10 mg once daily, whereas 1795 received a subcutaneous injection of 4000 international units of enoxaparin for the intended treatment duration of 2 to 12 weeks based on medical judgment.

The primary efficacy outcome was major VTE defined as the composite of symptomatic distal or proximal deep vein thrombosis, pulmonary embolism, or venous thromboembolism-related death during the treatment period, or asymptomatic proximal deep vein thrombosis following treatment.

The primary outcome occurred in 4 of 1661 patients (0.24%) in the rivaroxaban group compared with 18 patients (1.10%) in the enoxaparin group, leading the authors to conclude that rivaroxaban showed a statistically significant superiority in this patient population.

The main safety outcome was the frequency of bleeding events, and the researchers did not find a statistically significant difference between both groups. Major and nonmajor clinical relevant bleeding events occurred in 1.08% of the rivaroxaban group and 1.04% of the enoxaparin group, whereas the rates of major bleeding were 0.57% and 0.69%, respectively.

“This study provides evidence that rivaroxaban has the potential to become an effective preventive option, providing superior protection for these patients compared to the current standard of care,” Rosencher concluded.

REFERENCE

Rivaroxaban significantly reduced risk of major venous thromboembolism following nonmajor orthopedia surgery [news release]. Bayer Global; March 29, 2020. https://media.bayer.com/baynews/baynews.nsf/id/Rivaroxaban-significantly-reduced-major-venous-thromboembolism-following-nonmajor-orthopaedic?OpenDocument&sessionID=1585676566. Accessed March 31, 2020.