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Lancet. 2009 May 16;373(9676):1673-80. doi: 10.1016/S0140-6736(09)60734-0. Epub 2009 May 4.

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

Collaborators (171)

Turpie AG, Lassen MR, Davidson BL, Bauer KA, Gent M, Kwong LM, Cushner FD, Lotke PA, Fisher WD, Levine M, Bates S, Douketis JD, Hirsh J, Kearon C, Lee A, Schulman S, Thomson JG, Weitz J, Eriksson H, Sandgren G, Wallin J, Bassand JP, Bode C, Lüscher T, Angeras U, Falk A, Prins M, Leizorovicz A, Larrey D, Bounameaux H, Lehmacher W, Berkowitz SD, Bandel TJ, Misselwitz F, Benson A, Twomey TC, Lederman M, Zlatev R, Asparouhov AN, Stavrev V, Fisher W, Profitt A, Paez JG, Kruger G, Wollfrey M, Berkshire A, Puskas D, Kahn S, Ali P, Bredo L, Naude J, Abuzgaya F, Dessouki E, Dobson JC, Wai E, Pisesky W, Zalzal P, Robinson E, Lausten G, Jørgensen P, Gebuhr P, Lassen MR, Krarup N, Mikkelsen S, Reddy G, Mahajan S, Goni V, Shah H, Tapasvi S, Shah V, Malhorta R, Suryanarayan P, Behera SK, Mody B, Prasad B, Reddy G, Wakanker H, Rajagopalan R, Raju P, Sheth DN, Dhadi A, Agar G, Dekel S, Nyska M, Hendel D, Benkovich V, Salai M, Otremski I, Porvaneckas N, Smailys A, Belickas J, Sileika J, Tarasevicius R, Oyervides VS, Orazaco SR, Solórzano HR, Gómez RE, Hernández BR, Romero JG, Mendoza LG, Noor S, Idrees Z, Noor S, Górecki A, Dutka J, Siuda L, Sosnowski G, Kruczyinski J, Zieba T, Golnik R, Gazdzik T, Bednarek A, Mazurkiewicz S, Perera A, Perera M, Fernando P, Eriksson B, Ekstam AK, Hyldahl HC, Liliequist J, Johansson J, Ryttberg L, Gill G, Gimbel J, Whitaker D, Buettner C, Murray R, Comp P, Poole C, Buehler K, Allmacher D, Ward J, Papilion J, Colwell C, Kwong LM, Felsen A, Friedman R, Jove M, King R, Peters P, Emerson R, Bramlet D, Martin K, Fox D, Hollman M, Snyder M, Scott D, Sellers R, Kristensen R, Loucks D, Siff S, Kilgore J, Strain R, Skyhar M, Taunton O, Dalury D, Acevedo J, Whitfield P, Cherry K, Schwappach J, Bowen W, Heiser J, Gunnlaugson B, Jazayeri M, Tapadiya D, Goytia-Leos D, Rouhe R, Shah M, Vallier G, Schamblin M, Browne R.

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.

[PubMed - indexed for MEDLINE]
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