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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 a... Full description

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 Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: England: Elsevier Ltd
ID: ISSN: 0140-6736
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recordid: cdi_swepub_primary_oai_gup_ub_gu_se_155467
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
fulltext: fulltext
issn:
  • 0140-6736
  • 1474-547X
  • 1474-547X
url: Link


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titleRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial
sourceAlma/SFX Local Collection
creatorTurpie, 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
creatorcontribTurpie, 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
descriptionSummary 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.
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0ISSN: 0140-6736
1ISSN: 1474-547X
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3DOI: 10.1016/S0140-6736(09)60734-0
4PMID: 19411100
5CODEN: LANCAO
languageeng
publisherEngland: Elsevier Ltd
subjectAdministration ; 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
ispartofThe Lancet (British edition), 2009, Vol.373 (9676), p.1673-1680
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1Lassen, Michael R, MD
2Davidson, Bruce L, MD
3Bauer, Kenneth A, MD
4Gent, Michael, DSc
5Kwong, Louis M, MD
6Cushner, Fred D, MD
7Lotke, Paul A, MD
8Berkowitz, Scott D, MD
9Bandel, Tiemo J, MD
10Benson, Alice, MS
11Misselwitz, Frank, MD
12Fisher, William D, MD
13for the RECORD4 Investigators
14RECORD4 Investigators
15Sahlgrenska akademin
16Göteborgs universitet
17Institutionen för kliniska vetenskaper, Avdelningen för kirurgi
18Gothenburg University
19Institute of Clinical Sciences, Department of Surgery
20Sahlgrenska Academy
title
0Rivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial
1The Lancet (British edition)
addtitleLancet
descriptionSummary 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.
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1Administration, Oral
2adverse effects
3Aged
4Analysis of Variance
5Anticoagulants
6Anticoagulants (Medicine)
7Anticoagulants - therapeutic use
8Arthroplasty
9Arthroplasty, Replacement, Knee - adverse effects
10Blood transfusions
11chemically induced
12Comparative analysis
13Dosage and administration
14Double-Blind Method
15Drug therapy
16Enoxaparin
17Enoxaparin - therapeutic use
18epidemiology
19etiology
20Female
21Follow-Up Studies
22Hemorrhage
23Hemorrhage - chemically induced
24Hemorrhage - epidemiology
25Hospitals
26Humans
27Incidence
28Internal Medicine
29Joint surgery
30Kirurgi
31Knee
32Male
33Medical imaging
34Middle Aged
35Morpholines
36Morpholines - adverse effects
37Morpholines - therapeutic use
38Oral
39Patients
40Phlebography
41Prevention
42prevention & control
43Protease inhibitors
44radiography
45Replacement
46Risk factors
47Risk Reduction Behavior
48Rivaroxaban
49Sensitivity analysis
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51Studies
52Surgery
53therapeutic use
54Thiophenes
55Thiophenes - adverse effects
56Thiophenes - therapeutic use
57Thrombophlebitis
58Thrombosis
59Treatment Outcome
60Veins & arteries
61Venous Thrombosis
62Venous Thrombosis - diagnostic imaging
63Venous Thrombosis - epidemiology
64Venous Thrombosis - etiology
65Venous Thrombosis - prevention & control
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titleRivaroxaban versus enoxaparin for thromboprophylaxis after total knee arthroplasty (RECORD4): a randomised trial
authorTurpie, 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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21Follow-Up Studies
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27Incidence
28Internal Medicine
29Joint surgery
30Kirurgi
31Knee
32Male
33Medical imaging
34Middle Aged
35Morpholines
36Morpholines - adverse effects
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38Oral
39Patients
40Phlebography
41Prevention
42prevention & control
43Protease inhibitors
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48Rivaroxaban
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59Treatment Outcome
60Veins & arteries
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62Venous Thrombosis - diagnostic imaging
63Venous Thrombosis - epidemiology
64Venous Thrombosis - etiology
65Venous Thrombosis - prevention & control
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eissn1474-547X
codenLANCAO
abstractSummary 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.
copEngland
pubElsevier Ltd
pmid19411100
doi10.1016/S0140-6736(09)60734-0