DVT prophylaxis - antithrombotics - elective hip replacement clinical trials results meta-analysis

<h1> <a href="TM18-8-antithrombotics-DVTprophylaxis.html"> <strong>DVT prophylaxis</strong> - antithrombotics </a> - elective hip replacement trial results systematic overview and meta-analysis </h1> <h2>Main characteristics of the included studies</h2> <table> <tr> <th>Trial</th> <th>Treatments</th> <th>Patients</th> <th>Methods</th> </tr> <tr> <td> <a href="TRC_t4185.html"> Turpie, 1986 </a> <br> </td> <td> Enoxaparin 3000 x2<br>  <i>versus</i> <br> Placebo </td> <td> Elective hip </td> <td> follow-up 14 days or discharge<br> n=50/50<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t4188.html"> Torholm, 1991 </a> <br> </td> <td> dalteparin 5000x1<br>  <i>versus</i> <br> Placebo </td> <td> Elective hip </td> <td> follow-up 9 days<br> n=58/54<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t4189.html"> Lassen, 1991 </a> <br> </td> <td> tinzaparin 50/kg x1 +elastic stockings<br>  <i>versus</i> <br> Placebo+elastic stockings </td> <td> Elective hip </td> <td> follow-up 8-10 days<br> n=105/105<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t4190.html"> DES Group , 1991 </a> <br> </td> <td> Enoxaparin<br>  <i>versus</i> <br> Dextran </td> <td> Elective hip </td> <td> follow-up <br> n=120/126<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4191.html"> Eriksson , 1988 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Dextran </td> <td> Elective hip </td> <td> follow-up <br> n=50/50<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4192.html"> Matzsch , 1988 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Dextran </td> <td> Elective hip </td> <td> follow-up <br> n=48/52<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4193.html"> Matzsch , 1991 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Dextran </td> <td> Elective hip </td> <td> follow-up <br> n=120/123<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4194.html"> Planes , 1988 </a> <br> </td> <td> Enoxaparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=124/113<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4195.html"> Levine , 1991 </a> <br> </td> <td> Enoxaparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=333/332<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4196.html"> Chiapuzzo , 1988 </a> <br> </td> <td> Fluxum<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=70/70<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4197.html"> Pini , 1989 </a> <br> </td> <td> Fluxum<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Hip </td> <td> follow-up <br> n=25/24<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4198.html"> Haas , 1985 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=65/65<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4199.html"> Binsack , 1986 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=48/47<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4200.html"> Barre , 1987 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=40/40<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4201.html"> Dechavanne , 1989 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=82/40<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4202.html"> Eriksson , 1989 </a> <br> </td> <td> dalteparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=67/69<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4204.html"> Leyvraz , 1991 </a> <br> </td> <td> Fraxiparin<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=203/206<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4205.html"> Haas , 1987 </a> <br> </td> <td> Sandoz +0.5mg DHE<br>  <i>versus</i> <br> Unfractionated heparin </td> <td> Elective hip </td> <td> follow-up <br> n=80/80<br> <br> <br> </td> </tr> <tr> <td> <a href="TRC_t4206.html"> Lassen, 1988 </a> <br> </td> <td> certoparin 3000+0.5mg DHE, x1<br>  <i>versus</i> <br> Placebo </td> <td> Elective hip </td> <td> follow-up 6 days<br> n=118/122<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t4263.html"> Yoo, 1997 </a> <br> </td> <td> nadroparin 41/kgx1 days 1-3, 62/kg x1 days 4-11+elastic stockings<br>  <i>versus</i> <br> no treatment </td> <td> Elective hip </td> <td> follow-up 10 days<br> n=50/50<br> <br> open <br> </td> </tr> <tr> <td> <a href="TRC_t4264.html"> Samama, 1997 </a> <br> </td> <td> enoxaparin 4000x1+elastic stockings<br>  <i>versus</i> <br> Placebo+elastic stockings </td> <td> Elective hip </td> <td> follow-up 8-12 days<br> n=85/85<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t4266.html"> Kalodiki, 1996 </a> <br> </td> <td> enoxaparin 4000x1<br>  <i>versus</i> <br> Placebo </td> <td> Elective hip </td> <td> follow-up discharge (8-12 days )<br> n=13/14<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t4267.html"> Warwick, 1995 </a> <br> </td> <td> enoxaparin 4000x1 + elastic stockings<br>  <i>versus</i> <br> no treatment + elastic stockings </td> <td> Elective hip </td> <td> follow-up 8-10 days<br> n=78/78<br> <br> open <br> </td> </tr> <tr> <td> <a href="TRC_t6729.html"> RE-NOVATE (220mg), 2007 </a> <br> NCT00168818 </td> <td> dabigatran etexilate 220 mg q.d. for 28-35 days<br>  <i>versus</i> <br> Enoxaparin 40 mg q.d. </td> <td> Total hip replacement </td> <td> follow-up 28-35 days, median 33d<br> n=1157/1162<br> Parallel groups<br> double blind <br> Europe, Australia, South Africa </td> </tr> <tr> <td> <a href="index.html"> RE-NOVATE (150mg), 2007 </a> <br> NCT00168818 </td> <td> dabigatran etexilate 150 mg q.d. 28-35 days <br>  <i>versus</i> <br> Enoxaparin 40 mg q.d. </td> <td> Total hip replacement </td> <td> follow-up 28-35 days, median 33d<br> n=1174/1162<br> <br> double blind <br> Europe, Australia, South Africa </td> </tr> <tr> <td> <a href="index.html"> PENTATHLON (Turpie), 2002 </a> <br> </td> <td> fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery<br>  <i>versus</i> <br> enoxaparin 30mg twice daily (North america recommendation) </td> <td> elective hip replacement surgery </td> <td> follow-up 11 days<br> n=1138/1137<br> Parallel groups<br> double blind <br> USA, Canada, Australia </td> </tr> <tr> <td> <a href="index.html"> EPHESUS (Lassen), 2002 </a> <br> </td> <td> fondaparinux 2.5-mg once-daily subcutaneous, starting 6 hours after surgery<br>  <i>versus</i> <br> enoxaprin 40mg once daily </td> <td> elective hip replacement surgery </td> <td> follow-up 11 days (6 weeks)<br> n=1155/1154<br> Parallel groups<br> double blind <br> 16 European countries </td> </tr> <tr> <td> <a href="index.html"> Platinum (Colwell), 2003 </a> <br> </td> <td> Ximelagatran 24 mg orally b.d., starting at least 12 h after surgery for 7�12 days<br>  <i>versus</i> <br> Enoxaparin 30 mg s.c. b.d.,starting at least 12 h after surgery for 7�12 days </td> <td> adults undergoing hip replacement </td> <td> follow-up 7�12 days<br> n=906/910<br> parallel group<br> double-blind <br> USA, Canada, Israel, Mexico,Argentina, South Africa </td> </tr> <tr> <td> <a href="index.html"> METHRO III, 2002 </a> <br> </td> <td> Melagatran 3 mg s.c. 4�12h after surgery, then ximelagatran24 mg orally b.d. for 7�10 days<br>  <i>versus</i> <br> Enoxaparin 40 mg s.c. o.d. 12 h before surgery for 7�10 days </td> <td> hip or knee replacement </td> <td> follow-up 8�11 days<br> n=2788/0<br> <br> double-blind <br> Europe, South Africa </td> </tr> <tr> <td> <a href="index.html"> EXPRESS, 2003 </a> <br> </td> <td> Melagatran 2 mg s.c. up to 30 min before surgery, then melagatran 3 mg at least 8 hafter surgery, then ximelagatran 24 mg orally b.d. for 8�11 days<br>  <i>versus</i> <br> Enoxaparin 40 mg s.c. o.d.,starting 12 h before surgery for 8�11 days </td> <td> hip or knee replacement </td> <td> follow-up 8�11 days<br> n=2835/0<br> parallel group<br> double-blind <br> Europe </td> </tr> <tr> <td> <a href="index.html"> Stockholm-I, 1975 </a> <br> </td> <td> Aspirin 2000mg daily<br>  <i>versus</i> <br> placebo </td> <td> elective surgery of the hip </td> <td> follow-up 2 weeks<br> n=26/25<br> <br> double blind <br> </td> </tr> <tr> <td> <a href="index.html"> Harris-I, 1977 </a> <br> </td> <td> Aspirin 1200mg daily<br>  <i>versus</i> <br> placebo </td> <td> patients over 40 years of age, who had undergone total hip replacement </td> <td> follow-up 1 weeks<br> n=58/59<br> Parallel groups<br> double-blind <br> </td> </tr> <tr> <td> <a href="index.html"> Sautter, 1983 </a> <br> </td> <td> Aspirin 900mg daily + sulfinpyrazone<br>  <i>versus</i> <br> placebo </td> <td> patient with total hip replacement </td> <td> follow-up 3 weeks<br> n=68/77<br> Parallel groups<br> <br> </td> </tr> <tr> <td> <a href="index.html"> Cooke, 1977 </a> <br> </td> <td> Hydroxychloroquine<br>  <i>versus</i> <br> placebo </td> <td> elective surgery on the hip </td> <td> follow-up 2 weeks<br> n=25/25<br> Parallel groups<br> double-blind <br> </td> </tr> <tr> <td> <a href="index.html"> Rocha, 1986 </a> <br> </td> <td> Aspirin 250mg or 1000mg daily<br>  <i>versus</i> <br> control (combination of heparin plus dihydroergotamine) </td> <td> total hip replacement </td> <td> follow-up 1 weeks<br> n=60/30<br> Parallel groups<br> open <br> </td> </tr> <tr> <td> <a href="index.html"> Hume-A, 1977 </a> <br> </td> <td> Hydroxychloroquine<br>  <i>versus</i> <br> placebo </td> <td> total hip replacement </td> <td> follow-up 2 weeks<br> n=20/20<br> <br> <br> </td> </tr> <tr> <td> <a href="index.html"> Stockholm-II, 1981 </a> <br> </td> <td> Hydroxychloroquine<br>  <i>versus</i> <br> placebo </td> <td> total hip replacement </td> <td> follow-up 2 weeks<br> n=18/17<br> <br> <br> </td> </tr> <tr> <td> <a href="index.html"> ODIXa-HIP 10mg, 2006 </a> <br> </td> <td> rivaroxaban 10mg daily for 5�9 days<br>  <i>versus</i> <br> once-daily subcutaneous enoxaparin dose of 40 mg for 5�9 days </td> <td> patients undergoing elective total hip replacement </td> <td> follow-up 5-9 days<br> n=142/157<br> Parallel groups<br> double blind <br> Europe, Israel </td> </tr> <tr> <td> <a href="index.html"> DRIVE, 2008 </a> <br> NCT00338897 </td> <td> SR123781A for 5-10 days, doses ranging from 0.25 to 4.0 mg daily for 10 days<br>  <i>versus</i> <br> enoxaparin 40 mg </td> <td> patients undergoing total hip replacement surgery </td> <td> follow-up 5-10 days<br> n=854/169<br> Parallel groups<br> double blind <br> 12 countries </td> </tr> <tr> <td> <a href="index.html"> RECORD 1, 2008 </a> <br> NCT00329628 </td> <td> rivaroxaban 10mg once daily for 35 days<br>  <i>versus</i> <br> enoxaparin 40mg subcutaneous once daily </td> <td> patients undergoing total hip arthroplasty </td> <td> follow-up 36 days (range 30-42)<br> n=2209/2224<br> Parallel groups<br> double blind <br> 27 countries worldwide </td> </tr> <tr> <td> <a href="index.html"> RECORD 2, 2008 </a> <br> NCT00332020 </td> <td> extended thromboprophylaxis with rivaroxaban 10mg once daily for 31-39 days<br>  <i>versus</i> <br> short-term thromboprophylaxis with enoxaparin 40mg subcutaneous once daily for 10-14 days </td> <td> patients undergoing elective total hip replacement </td> <td> follow-up 30-42 days<br> n=1252/1257<br> Parallel groups<br> double blind <br> 21 countries worldwide </td> </tr> <tr> <td> <a href="index.html"> Ericksson, 1997 </a> <br> </td> <td> desirudin 15mg SC twice daily for 8-12 days<br>  <i>versus</i> <br> enoxaparin 40mg once daily for 8-12 days </td> <td> Patients who undergo total hip replacement </td> <td> follow-up <br> n=-9/-9<br> Parallel groups<br> double blind <br> Europe </td> </tr> <tr> <td> <a href="index.html"> REVASC, 1997 </a> <br> </td> <td> desirudin 15mg twice daily<br>  <i>versus</i> <br> unfractionated heparin 5000 IU three times a day </td> <td> patients having a primary elective total hip replacement </td> <td> follow-up <br> n=225/220<br> Parallel groups<br> <br> </td> </tr> <tr> <td> <a href="index.html"> Eriksson, 1996 </a> <br> </td> <td> recombinant hirudin, desirudin (CGP 39393) 10, 15, or 20 mg twice daily started just before surgery and continued for 8-11 days<br>  <i>versus</i> <br> unfractionated heparin 5000 IU three times daily started just before surgery and continued for 8-11 days </td> <td> patients undergoing elective hip surgery </td> <td> follow-up <br> n=1119/0<br> Parallel groups<br> double blind <br> Europe </td> </tr> <tr> <td> <a href="TRC_t11113.html"> RE-NOVATE 2, 2010 </a> <br> NCT00657150 </td> <td> dabigatran 220mg once daily for 28-35 Days<br>  <i>versus</i> <br> enoxaparin 40mg subcutaneous </td> <td> patients undergoing total hip-replacement surgery </td> <td> follow-up 28-35 days (mean 32d)<br> n=1010/1003<br> Parallel groups<br> double-blind <br> </td> </tr> <tr> <td> <a href="TRC_t10332.html"> CV185-035, </a> <br> NCT00423319 </td> <td> apixaban 2.5mg twice daily 5 weeks<br>  <i>versus</i> <br> enoxaparin 40mg once daily 5 weeks </td> <td> patients undergoing elective total hip replacement surger </td> <td> follow-up 35 days<br> n=5406/0<br> Parallel groups<br> double blind <br> </td> </tr> <tr> <td> <a href="TRC_t10385.html"> NCT00320398, 0 </a> <br> NCT00320398 </td> <td> Fondaparinux<br>  <i>versus</i> <br> </td> <td> patients undergoing either an elective primary total hip replacement (THR) surgery or a revision of a THR </td> <td> follow-up <br> n=-9/-9<br> <br> double-blind <br> Japan </td> </tr> </table> <h2>References</h2> <p> <b>Turpie, 1986 : </b> Turpie AG, Levine MN, Hirsh J, Carter CJ, Jay RM, Powers PJ, Andrew M, Hull RD, Gent MA randomized controlled trial of a low-molecular-weight heparin (enoxaparin) to prevent deep-vein thrombosis in patients undergoing elective hip surgery. <i>N Engl J Med 1986 Oct 9;315:925-9</i> [PMID 3531851] </p> <p> <b>Torholm, 1991 : </b> Torholm C, Broeng L, Jorgensen PS, Bjerregaard P, Josephsen L, Jorgensen PK, Hagen K, Knudsen JBThromboprophylaxis by low-molecular-weight heparin in elective hip surgery. A placebo controlled study. <i>J Bone Joint Surg Br 1991 May;73:434-8</i> [PMID 1670445] </p> <p> <b>Lassen, 1991 : </b> Lassen MR, Borris LC, Christiansen HM, Boll KL, Eiskjaer SP, Nielsen BW, Sch�tt P, Olsen AD, Rodenberg JC, Lucht UPrevention of thromboembolism in 190 hip arthroplasties. Comparison of LMW heparin and placebo. <i>Acta Orthop Scand 1991;62:33-8</i> [PMID 1848385] </p> <p> <b>Eriksson , 1988 : </b> Eriksson BI, Zachrisson BE, Teger-Nilsson AC, Risberg BThrombosis prophylaxis with low molecular weight heparin in total hip replacement. <i>Br J Surg 1988 Nov;75:1053-7</i> [PMID 2463035] </p> <p> <b>Planes , 1988 : </b> Planes A, Vochelle N, Mazas F, Mansat C, Zucman J, Landais A, Pascariello JC, Weill D, Butel JPrevention of postoperative venous thrombosis: a randomized trial comparing unfractionated heparin with low molecular weight heparin in patients undergoing total hip replacement. <i>Thromb Haemost 1988 Dec 22;60:407-10</i> [PMID 2853459] </p> <p> <b>Chiapuzzo , 1988 : </b> Chiapuzzo E, Orengo GB, Ottria G, Chiapuzzo A, Palazzini E, Fusillo MThe use of low molecular weight heparins for postsurgical deep vein thrombosis prevention in orthopaedic patients. <i>J Int Med Res 1988 Sep-Oct;16:359-66</i> [PMID 3197913] </p> <p> <b>Pini , 1989 : </b> Pini M, Tagliaferri A, Manotti C, Lasagni F, Rinaldi E, Dettori AGLow molecular weight heparin (Alfa LHWH) compared with unfractionated heparin in prevention of deep-vein thrombosis after hip fractures. <i>Int Angiol 1989 Jul-Sep;8:134-9</i> [PMID 2556484] </p> <p> <b>Dechavanne , 1989 : </b> Dechavanne M, Ville D, Berruyer M, Trepo F, Dalery F, Clermont N, Lerat JL, Moyen B, Fischer LP, Kher ARandomized trial of a low-molecular-weight heparin (Kabi 2165) versus adjusted-dose subcutaneous standard heparin in the prophylaxis of deep-vein thrombosis after elective hip surgery. <i>Haemostasis 1989;19:5-12</i> [PMID 2537787] </p> <p> <b>Leyvraz , 1991 : </b> Leyvraz PF, Bachmann F, Hoek J, Buller HR, Postel M, Samama M, Vandenbroek MDPrevention of deep vein thrombosis after hip replacement: randomised comparison between unfractionated heparin and low molecular weight heparin. <i>BMJ 1991 Sep 7;303:543-8</i> [PMID 1655136] </p> <p> <b>Haas , 1987 : </b> Haas S, Stemberger A, Fritsche HM, Welzel D, Wolf H, Lechner F, Blumel GProphylaxis of deep vein thrombosis in high risk patients undergoing total hip replacement with low molecular weight heparin plus dihydroergotamine. <i>Arzneimittelforschung 1987 Jul;37:839-43</i> [PMID 2823840] </p> <p> <b>Lassen, 1988 : </b> Lassen MR, Borris LC, Christiansen HM, Moller-Larsen F, Knudsen VE, Boris P, Nehen AM, de Carvalho A, Jurik AG, Nielsen BWHeparin/dihydroergotamine for venous thrombosis prophylaxis: comparison of low-dose heparin and low molecular weight heparin in hip surgery. <i>Br J Surg 1988 Jul;75:686-9</i> [PMID 2843255] </p> <p> <b>Yoo, 1997 : </b> Yoo MC, Kang CS, Kim YH, Kim SKA prospective randomized study on the use of nadroparin calcium in the prophylaxis of thromboembolism in Korean patients undergoing elective total hip replacement. <i>Int Orthop 1997;21:399-402</i> [PMID 9498151] </p> <p> <b>Samama, 1997 : </b> Samama CM, Clergue F, Barre J, Montefiore A, Ill P, Samii KLow molecular weight heparin associated with spinal anaesthesia and gradual compression stockings in total hip replacement surgery. 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Is it effective and safe. <i>J Bone Joint Surg Br 1995 Sep;77:715-9</i> [PMID 7559695] </p> <p> <b>RE-NOVATE (220mg), 2007 : </b> Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, B�ller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. <i>Lancet 2007;370:949-56</i> [PMID 17869635] </p> <p> <b>RE-NOVATE (150mg), 2007 : </b> Eriksson BI, Dahl OE, Rosencher N, Kurth AA, van Dijk CN, Frostick SP, Prins MH, Hettiarachchi R, Hantel S, Schnee J, B�ller HRDabigatran etexilate versus enoxaparin for prevention of venous thromboembolism after total hip replacement: a randomised, double-blind, non-inferiority trial. <i>Lancet 2007;370:949-56</i> [PMID 17869635] </p> <p> <b>PENTATHLON (Turpie), 2002 : </b> Turpie AG, Bauer KA, Eriksson BI, Lassen MRPostoperative fondaparinux versus postoperative enoxaparin for prevention of venous thromboembolism after elective hip-replacement surgery: a randomised double-blind trial. <i>Lancet 2002 May 18;359:1721-6</i> [PMID 12049860] </p> <p> <b>EPHESUS (Lassen), 2002 : </b> Lassen MR, Bauer KA, Eriksson BI, Turpie AGPostoperative fondaparinux versus preoperative enoxaparin for prevention of venous thromboembolism in elective hip-replacement surgery: a randomised double-blind comparison. <i>Lancet 2002 May 18;359:1715-20</i> [PMID 12049858] </p> <p> <b>Platinum (Colwell), 2003 : </b> Colwell CW Jr, Berkowitz SD, Davidson BL, Lotke PA, Ginsberg JS, Lieberman JR, Neubauer J, McElhattan JL, Peters GR, Francis CWComparison of ximelagatran, an oral direct thrombin inhibitor, with enoxaparin for the prevention of venous thromboembolism following total hip replacement. 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