@article{851eb5306c0611dfa4b2000ea68e967b,
title = "Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial",
abstract = "BACKGROUND: Prophylaxis for venous thromboembolism is recommended for at least 10 days after total knee arthroplasty; oral regimens could enable shorter hospital stays. We aimed to test the efficacy and safety of oral rivaroxaban for the prevention of venous thromboembolism after total knee arthroplasty. METHODS: In a randomised, double-blind, phase III study, 3148 patients undergoing knee arthroplasty received either oral rivaroxaban 10 mg once daily, beginning 6-8 h after surgery, or subcutaneous enoxaparin 30 mg every 12 h, starting 12-24 h after surgery. Patients had mandatory bilateral venography between days 11 and 15. The primary efficacy outcome was the composite of any deep-vein thrombosis, non-fatal pulmonary embolism, or death from any cause up to day 17 after surgery. Efficacy was assessed as non-inferiority of rivaroxaban compared with enoxaparin in the per-protocol population (absolute non-inferiority limit -4%); if non-inferiority was shown, we assessed whether rivaroxaban had superior efficacy in the modified intention-to-treat population. The primary safety outcome was major bleeding. This trial is registered with ClinicalTrials.gov, number NCT00362232. FINDINGS: The primary efficacy outcome occurred in 67 (6.9%) of 965 patients given rivaroxaban and in 97 (10.1%) of 959 given enoxaparin (absolute risk reduction 3.19%, 95% CI 0.71-5.67; p=0.0118). Ten (0.7%) of 1526 patients given rivaroxaban and four (0.3%) of 1508 given enoxaparin had major bleeding (p=0.1096). INTERPRETATION: Oral rivaroxaban 10 mg once daily for 10-14 days was significantly superior to subcutaneous enoxaparin 30 mg given every 12 h for the prevention of venous thromboembolism after total knee arthroplasty. FUNDING: Bayer Schering Pharma AG, Johnson & Johnson Pharmaceutical Research & Development.",
author = "Turpie, {Alexander G G} and Lassen, {Michael R} and Davidson, {Bruce L} and Bauer, {Kenneth A} and Michael Gent and Kwong, {Louis M} and Cushner, {Fred D} and Lotke, {Paul A} and Berkowitz, {Scott D} and Bandel, {Tiemo J} and Alice Benson and Frank Misselwitz and Fisher, {William D}",
note = "Keywords: Administration, Oral; Aged; Analysis of Variance; Anticoagulants; Arthroplasty, Replacement, Knee; Double-Blind Method; Enoxaparin; Female; Follow-Up Studies; Hemorrhage; Humans; Incidence; Male; Middle Aged; Morpholines; Phlebography; Risk Reduction Behavior; Sensitivity and Specificity; Thiophenes; Treatment Outcome; Venous Thrombosis",
year = "2009",
doi = "10.1016/S0140-6736(09)60734-0",
language = "English",
volume = "373",
pages = "1673--80",
journal = "Lancet",
issn = "1474-547X",
publisher = "The/Lancet Publishing Group",
number = "9676",
}