A non-interventional comparison of rivaroxaban with standard of care for thromboprophylaxis after major orthopaedic surgery in 17,701 patients with propensity score adjustment

Abstract

Rivaroxaban demonstrated superior efficacy and a similar safety profile to enoxaparin for the prevention of venous thromboembolism in the phase III RECORD programme in patients undergoing elective hip or knee replacement surgery. The XAMOS study investigated adverse events, including bleeding and thromboembolic events, in patients receiving rivaroxaban for thromboprophylaxis in routine clinical practice. XAMOS was a non-interventional, open-label cohort study in patients undergoing major orthopaedic surgery of the hip or knee (predominantly elective arthroplasty), in which rivaroxaban was compared with other pharmacological thromboprophylaxis. All adverse events were documented, including symptomatic thromboembolic and bleeding events. Crude and adjusted incidences based on propensity score subclasses were calculated and compared between the rivaroxaban and standard-of-care groups. A total of 17,701 patients were enrolled from 252 centres in 37 countries. Crude incidences of symptomatic thromboembolic events three months after surgery in the safety population were 0.89% in the rivaroxaban group (n=8,778) and 1.35% in the standard-of-care group (n=8,635; odds ratio [OR] 0.65; 95% confidence interval [CI] 0.49-0.87), and 0.91% and 1.31% (weighted) in the propensity score-adjusted analysis (OR 0.69; 95% CI 0.56-0.85), respectively. Treatment-emergent major bleeding events (as defined in the RECORD studies) occurred in 0.40% and 0.34% of patients in the rivaroxaban and standard-of-care groups in the safety population (OR 1.19; 95% CI 0.73-1.95), and in 0.44% versus 0.33% (weighted) in the propensity score-adjusted analysis (OR 1.35; 95% CI 0.94-1.93), respectively.This study in unselected patients confirmed the favourable benefit-risk profile of rivaroxaban seen in the RECORD programme.

Rivaroxaban compared with standard thromboprophylaxis after major orthopaedic surgery: co‐medication interactions

“…The safety population included 17 413 patients – 8778 received rivaroxaban and 8635 received SOC (81.7% received low molecular weight heparins, 7.9% fondaparinux, 5.5% dabigatran etexilate and 4.9% other agents). In the safety population of the overall XAMOS study, the crude incidences of symptomatic thromboembolic events were 0.89% and 1.35% in the rivaroxaban and SOC groups, respectively (OR = 0.65; 95% CI 0.49, 0.87) as reported [6]. Treatment‐emergent major bleeding events occurred in the overall study in 0.40% and 0.34% of patients in the rivaroxaban and SOC groups, respectively (OR = 1.19; 95% CI 0.73, 1.95; RECORD definition) as reported [6].…”

“…XAMOS was a non‐interventional, open‐label cohort study conducted in 252 centres in 37 countries 6. Patients aged ≥18 years who were scheduled to undergo elective hip or knee replacement surgery (or fracture surgery in countries in which rivaroxaban was approved for this indication), and in whom a decision on pharmacological thromboprophylaxis had already been made, were eligible for inclusion in XAMOS.…”

“…The use of co‐medications was at the discretion of the treating physician. Of the 17 701 enrolled patients, 17 413 were included in the safety population – defined as patients who received at least one dose of a thromboprophylactic drug (rivaroxaban or SOC) 6.…”

“…The approval of rivaroxaban for the prevention of venous thromboembolism (VTE) in patients undergoing elective hip or knee replacement surgery was based on the outcomes of the phase III (RECORD) Regulation of Coagulation in Orthopaedic Surgery to Prevent Deep Vein Thrombosis and Pulmonary Embolism studies, in which rivaroxaban demonstrated superior efficacy and a similar safety profile to prophylactic regimens of enoxaparin 2, 3, 4, 5. More recently, the results from the XAMOS (Xarelto® in the prophylaxis of postsurgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study, a phase IV, non‐interventional, observational study, have been published and provide evidence that the results of the phase III RECORD trials can be translated into routine clinical practice 6. In unselected patients undergoing major orthopaedic surgery, rivaroxaban 10 mg once daily was associated with a significantly lower incidence of symptomatic thromboembolic events compared with other pharmacological thromboprophylaxis [standard of care (SOC)] 6.…”

“…More recently, the results from the XAMOS (Xarelto® in the prophylaxis of postsurgical venous thromboembolism after elective major orthopaedic surgery of hip or knee) study, a phase IV, non‐interventional, observational study, have been published and provide evidence that the results of the phase III RECORD trials can be translated into routine clinical practice 6. In unselected patients undergoing major orthopaedic surgery, rivaroxaban 10 mg once daily was associated with a significantly lower incidence of symptomatic thromboembolic events compared with other pharmacological thromboprophylaxis [standard of care (SOC)] 6. Unlike randomized controlled trials, which select patients using prespecified and often strict inclusion and exclusion criteria, patients treated in routine clinical practice are likely to have other co‐morbidities and to take other medications for acute or chronic conditions.…”