Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial

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• 作者：Alex ; er GG Turpie ; Michael R Lassen ; Bruce L Davidson ; Kenneth A Bauer ; Michael Gent ; Louis M Kwong ; Fred D Cushner ; Paul A Lotke ; Scott D Berkowitz ; Tiemo J B ; el ; Alice Benson ; Frank Misselwitz ; Will
• 刊名：The Lancet
• 出版年：2009
• 出版时间：16 May 2009-22 May 2009
• 年：2009
• 卷：373
• 期：9676
• 页码：1673-1680
• 全文大小：145 K

文摘

Summary

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.