title: 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.
authors.affiliation: Alexander G. G. Turpie, MD, Department of Medicine, Hamilton Health Sciences, General Division, 237 Barton Street East, Hamilton, Ontario, Canada, Tel.: +1 905 929 4385, Fax: +1 905 628 9505, E-mail: turpiea@mcmaster.ca.
authors.forename: Alexander G G
authors.initials: AG
authors.lastname: Turpie
authors.forename: Sylvia
authors.initials: S
authors.lastname: Haas
authors.forename: Reinhold
authors.initials: R
authors.lastname: Kreutz
authors.forename: Lorenzo G
authors.initials: LG
authors.lastname: Mantovani
authors.forename: Cassandra W
authors.initials: CW
authors.lastname: Pattanayak
authors.forename: Gerlind
authors.initials: G
authors.lastname: Holberg
authors.forename: Waheed
authors.initials: W
authors.lastname: Jamal
authors.forename: André
authors.initials: A
authors.lastname: Schmidt
authors.forename: Martin
authors.initials: M
authors.lastname: van Eickels
authors.forename: Michael R
authors.initials: MR
authors.lastname: Lassen
mesh_terms: D000284:Administration, Oral; D000368:Aged; D000925:Anticoagulants / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D019644:Arthroplasty, Replacement, Hip / Q000379:methods*; D019645:Arthroplasty, Replacement, Knee / Q000379:methods*; D015331:Cohort Studies; D003627:Data Interpretation, Statistical; D017984:Enoxaparin / Q000627:therapeutic use; D005260:Female; D006470:Hemorrhage / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016017:Odds Ratio; D057216:Propensity Score; D012306:Risk; D000069552:Rivaroxaban; D059039:Standard of Care; D013876:Thiophenes / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D054556:Venous Thromboembolism / Q000517:prevention & control*
chemical_list: D000925:Anticoagulants; D017984:Enoxaparin; D009025:Morpholines; D013876:Thiophenes; D000069552:Rivaroxaban
keywords: Symptomatic thromboembolic events; bleeding events; orthopaedic surgery; rivaroxaban; thromboprophylaxis