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

被引：755

作者：

Turpie, Alexander G. G. ^{[1
]}

Lassen, Michael R. ^{[2
]}

Davidson, Bruce L. ^{[3
]}

Bauer, Kenneth A. ^{[4
]}

Gent, Michael ^{[1
]}

Kwong, Louis M. ^{[5
]}

Cushner, Fred D. ^{[6
]}

Lotke, Paul A. ^{[7
]}

Berkowitz, Scott D. ^{[8
]}

Bandel, Tiemo J. ^{[8
]}

Benson, Alice ^{[8
]}

Misselwitz, Frank ^{[8
]}

Fisher, William D. ^{[9
]}

机构：

[1] McMaster Univ, Hamilton, ON L8L 2X2, Canada

[2] Horsholm Hosp, Horsholm, Denmark

[3] Weill Cornell Med Coll, Doha, Qatar

[4] Beth Israel Deaconess Med Ctr, Boston, MA 02215 USA

[5] Harbor UCLA Med Ctr, Torrance, CA 90509 USA

[6] Insall Scott Kelly Ctr Orthopaed & Sports Med, New York, NY USA

[7] Univ Penn, Med Ctr, Philadelphia, PA 19104 USA

[8] Bayer Schering Pharma AG, Wuppertal, Germany

[9] McGill Univ, Ctr Hlth, Montreal, PQ, Canada

来源：

LANCET | 2009年 / 373卷 / 9676期

关键词：

DIRECT THROMBIN INHIBITOR; MOLECULAR-WEIGHT HEPARIN; VENOUS THROMBOEMBOLISM; DOUBLE-BLIND; PREVENTION; XIMELAGATRAN; PROPHYLAXIS;

D O I：

10.1016/S0140-6736(09)60734-0

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

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% Cl 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.

引用

页码：1673 / 1680

页数：8

共 15 条

[11] Extended duration rivaroxaban versus short-term enoxaparin for the prevention of venous thromboembolism after total hip arthroplasty: a double-blind, randomised controlled trial [J].