Oral Antithrombotic Shows Promise in Orthopedic Surgery

Rivaroxaban, a factor Xa inhibitor, reduces thrombotic complications in patients undergoing major orthopedic surgery, according to three safety and efficacy studies published in Lancet and the New England Journal of Medicine.

Researchers in three RECORD trials randomized roughly 6500 patients undergoing hip or knee replacement to either oral rivaroxaban or subcutaneous enoxaparin daily for up to 5 weeks (knee-replacement patients received less than 2 weeks' treatment). To preserve double blinding, patients also received placebo injections or pills. Drug manufacturers collected and analyzed the data.

The primary outcome, a composite of deep-venous thrombosis, pulmonary embolism, and all-cause mortality, occurred significantly less often in the rivaroxaban groups. Rates of major bleeding and toxicity were roughly the same with the two drugs.

In Journal Watch Oncology and Hematology, David Green points to the efficacy of rivaroxaban, but says proof of its safety will depend on postmarketing surveillance.