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

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.

Journal Title:	The Lancet (British edition) 2009, Vol.373 (9676), p.1673-1680
Main Author:	Turpie, Alexander GG, MD
Other Authors:	Lassen, Michael R, MD , Davidson, Bruce L, MD , Bauer, Kenneth A, MD , Gent, Michael, DSc , Kwong, Louis M, MD , Cushner, Fred D, MD , Lotke, Paul A, MD , Berkowitz, Scott D, MD , Bandel, Tiemo J, MD , Benson, Alice, MS , Misselwitz, Frank, MD , Fisher, William D, MD
Format:	Electronic Article
Language:	English
Subjects:	Administration Administration, Oral adverse effects Aged Analysis of Variance Anticoagulants Anticoagulants (Medicine) Anticoagulants - therapeutic use Arthroplasty Arthroplasty, Replacement, Knee - adverse effects Blood transfusions chemically induced Comparative analysis Dosage and administration Double-Blind Method Drug therapy Enoxaparin Enoxaparin - therapeutic use epidemiology etiology Female Follow-Up Studies Hemorrhage Hemorrhage - chemically induced Hemorrhage - epidemiology Hospitals Humans Incidence Internal Medicine Joint surgery Kirurgi Knee Male Medical imaging Middle Aged Morpholines Morpholines - adverse effects Morpholines - therapeutic use Oral Patients Phlebography Prevention prevention & control Protease inhibitors radiography Replacement Risk factors Risk Reduction Behavior Rivaroxaban Sensitivity analysis Sensitivity and Specificity Studies Surgery therapeutic use Thiophenes Thiophenes - adverse effects Thiophenes - therapeutic use Thrombophlebitis Thrombosis Treatment Outcome Veins & arteries Venous Thrombosis Venous Thrombosis - diagnostic imaging Venous Thrombosis - epidemiology Venous Thrombosis - etiology Venous Thrombosis - prevention & control
Quelle:	Alma/SFX Local Collection
Publisher:	England: Elsevier Ltd
ID:	ISSN: 0140-6736
Zum Text:

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title:	Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial
format:	Article
creator:	Turpie, Alexander GG, MD Lassen, Michael R, MD Davidson, Bruce L, MD Bauer, Kenneth A, MD Gent, Michael, DSc Kwong, Louis M, MD Cushner, Fred D, MD Lotke, Paul A, MD Berkowitz, Scott D, MD Bandel, Tiemo J, MD Benson, Alice, MS Misselwitz, Frank, MD Fisher, William D, MD
subjects:	Administration Administration, Oral adverse effects Aged Analysis of Variance Anticoagulants Anticoagulants (Medicine) Anticoagulants - therapeutic use Arthroplasty Arthroplasty, Replacement, Knee - adverse effects Blood transfusions chemically induced Comparative analysis Dosage and administration Double-Blind Method Drug therapy Enoxaparin Enoxaparin - therapeutic use epidemiology etiology Female Follow-Up Studies Hemorrhage Hemorrhage - chemically induced Hemorrhage - epidemiology Hospitals Humans Incidence Internal Medicine Joint surgery Kirurgi Knee Male Medical imaging Middle Aged Morpholines Morpholines - adverse effects Morpholines - therapeutic use Oral Patients Phlebography Prevention prevention & control Protease inhibitors radiography Replacement Risk factors Risk Reduction Behavior Rivaroxaban Sensitivity analysis Sensitivity and Specificity Studies Surgery therapeutic use Thiophenes Thiophenes - adverse effects Thiophenes - therapeutic use Thrombophlebitis Thrombosis Treatment Outcome Veins & arteries Venous Thrombosis Venous Thrombosis - diagnostic imaging Venous Thrombosis - epidemiology Venous Thrombosis - etiology Venous Thrombosis - prevention & control
ispartof:	The Lancet (British edition), 2009, Vol.373 (9676), p.1673-1680
description:	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.
language:	eng
source:	Alma/SFX Local Collection
identifier:	ISSN: 0140-6736
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Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial

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Turpie, Alexander GG, MD ; Lassen, Michael R, MD ; Davidson, Bruce L, MD ; Bauer, Kenneth A, MD ; Gent, Michael, DSc ; Kwong, Louis M, MD ; Cushner, Fred D, MD ; Lotke, Paul A, MD ; Berkowitz, Scott D, MD ; Bandel, Tiemo J, MD ; Benson, Alice, MS ; Misselwitz, Frank, MD ; Fisher, William D, MD ; for the RECORD4 Investigators ; RECORD4 Investigators ; Sahlgrenska akademin ; Göteborgs universitet ; Institutionen för kliniska vetenskaper, Avdelningen för kirurgi ; Gothenburg University ; Institute of Clinical Sciences, Department of Surgery ; Sahlgrenska Academy

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0	ISSN: 0140-6736
1	ISSN: 1474-547X
2	EISSN: 1474-547X
3	DOI: 10.1016/S0140-6736(09)60734-0
4	PMID: 19411100
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England: Elsevier Ltd

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Administration ; Administration, Oral ; adverse effects ; Aged ; Analysis of Variance ; Anticoagulants ; Anticoagulants (Medicine) ; Anticoagulants - therapeutic use ; Arthroplasty ; Arthroplasty, Replacement, Knee - adverse effects ; Blood transfusions ; chemically induced ; Comparative analysis ; Dosage and administration ; Double-Blind Method ; Drug therapy ; Enoxaparin ; Enoxaparin - therapeutic use ; epidemiology ; etiology ; Female ; Follow-Up Studies ; Hemorrhage ; Hemorrhage - chemically induced ; Hemorrhage - epidemiology ; Hospitals ; Humans ; Incidence ; Internal Medicine ; Joint surgery ; Kirurgi ; Knee ; Male ; Medical imaging ; Middle Aged ; Morpholines ; Morpholines - adverse effects ; Morpholines - therapeutic use ; Oral ; Patients ; Phlebography ; Prevention ; prevention & control ; Protease inhibitors ; radiography ; Replacement ; Risk factors ; Risk Reduction Behavior ; Rivaroxaban ; Sensitivity analysis ; Sensitivity and Specificity ; Studies ; Surgery ; therapeutic use ; Thiophenes ; Thiophenes - adverse effects ; Thiophenes - therapeutic use ; Thrombophlebitis ; Thrombosis ; Treatment Outcome ; Veins & arteries ; Venous Thrombosis ; Venous Thrombosis - diagnostic imaging ; Venous Thrombosis - epidemiology ; Venous Thrombosis - etiology ; Venous Thrombosis - prevention & control

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The Lancet (British edition), 2009, Vol.373 (9676), p.1673-1680

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1	Lassen, Michael R, MD
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5	Kwong, Louis M, MD
6	Cushner, Fred D, MD
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9	Bandel, Tiemo J, MD
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11	Misselwitz, Frank, MD
12	Fisher, William D, MD
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15	Sahlgrenska akademin
16	Göteborgs universitet
17	Institutionen för kliniska vetenskaper, Avdelningen för kirurgi
18	Gothenburg University
19	Institute of Clinical Sciences, Department of Surgery
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title	Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial
author	Turpie, Alexander GG, MD ; Lassen, Michael R, MD ; Davidson, Bruce L, MD ; Bauer, Kenneth A, MD ; Gent, Michael, DSc ; Kwong, Louis M, MD ; Cushner, Fred D, MD ; Lotke, Paul A, MD ; Berkowitz, Scott D, MD ; Bandel, Tiemo J, MD ; Benson, Alice, MS ; Misselwitz, Frank, MD ; Fisher, William D, MD

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5	Anticoagulants
6	Anticoagulants (Medicine)
7	Anticoagulants - therapeutic use
8	Arthroplasty
9	Arthroplasty, Replacement, Knee - adverse effects
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40	Phlebography
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45	Replacement
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48	Rivaroxaban
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51	Studies
52	Surgery
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55	Thiophenes - adverse effects
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57	Thrombophlebitis
58	Thrombosis
59	Treatment Outcome
60	Veins & arteries
61	Venous Thrombosis
62	Venous Thrombosis - diagnostic imaging
63	Venous Thrombosis - epidemiology
64	Venous Thrombosis - etiology
65	Venous Thrombosis - prevention & control

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1	Lassen, Michael R, MD
2	Davidson, Bruce L, MD
3	Bauer, Kenneth A, MD
4	Gent, Michael, DSc
5	Kwong, Louis M, MD
6	Cushner, Fred D, MD
7	Lotke, Paul A, MD
8	Berkowitz, Scott D, MD
9	Bandel, Tiemo J, MD
10	Benson, Alice, MS
11	Misselwitz, Frank, MD
12	Fisher, William D, MD
13	for the RECORD4 Investigators
14	RECORD4 Investigators
15	Sahlgrenska akademin
16	Göteborgs universitet
17	Institutionen för kliniska vetenskaper, Avdelningen för kirurgi
18	Gothenburg University
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0	Turpie, Alexander GG, MD
1	Lassen, Michael R, MD
2	Davidson, Bruce L, MD
3	Bauer, Kenneth A, MD
4	Gent, Michael, DSc
5	Kwong, Louis M, MD
6	Cushner, Fred D, MD
7	Lotke, Paul A, MD
8	Berkowitz, Scott D, MD
9	Bandel, Tiemo J, MD
10	Benson, Alice, MS
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5	Gothenburg University
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7	Sahlgrenska Academy

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atitle

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

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The Lancet (British edition)

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date

2009

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2009

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373

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England

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Elsevier Ltd

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19411100

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10.1016/S0140-6736(09)60734-0

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Bibliotheken

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