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

Journal: Thrombosis and Haemostasis
ISSN: 0340-6245
Issue: 2014: 111/1 (Jan) pp. 1–189
Pages: 94-102

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

Online Supplementary Material

A. G. G. Turpie (1), S. Haas (2), R. Kreutz (3), L. G. Mantovani (4), C. W. Pattanayak (5), G. Holberg (6), W. Jamal (6), A. Schmidt (6), M. van Eickels (6), M. R. Lassen (7)

(1) Department of Medicine, Hamilton Health Sciences, Hamilton, Ontario, Canada; (2) Institute for Experimental Oncology and Therapy Research, Technical University of Munich, Munich, Germany; (3) Institut für Klinische Pharmakologie und Toxikologie, Charité-Universitätsmedizin, Berlin, Germany; (4) Dipartimento di Medicina Clinica e Chirurgia, Università degli Studi di Napoli Federico II, Naples, Italy; (5) Harvard University Statistics Department (current address: Quantitative Analysis Institute, Wellesley College, Wellesley, Massachusetts, USA); (6) Bayer HealthCare AG, Berlin, Germany; (7) Glostrup Hospital, Spine Center, Clinical Trial Unit, University of Copenhagen, Glostrup, Denmark


thromboprophylaxis, orthopaedic surgery, rivaroxaban, Symptomatic thromboembolic events, bleeding events


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.

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