Prevention of Deep Vein Thrombosis after Hip Replacement

Summary

Consecutive patients undergoing total hip replacement in 43 centres were randomly assigned to receive blindly either enoxaparin (40 mg) or tinzaparin (4,500 anti-Factor IU Xa), as once daily subcutaneous injections. The first injection was administered 12 h preoperatively. Efficacy was assessed by bilateral venography performed 12-14 days postoperatively. Efficacy and safety were blindly and centrally adjudicated. Among the 499 patients included, 440 had a venogram. The total incidence of DVTs was 44 (20.1%) of the 219 patients of the enoxaparin group and 48 (21.7%) of the 221 patients of the tinzaparin group. The upper limit of the 80% confidence interval of the difference between the two treatment groups was less than 5.0%. Therefore according to the protocol’s specifications equivalence was shown. Proximal DVTs occurred in 10.5% of the enoxaparin group (23 patients) and in 9.5% (21 patients) of the tinzaparin group. No overt major bleeding was observed. One patient in the enoxaparin group developed severe thrombocytopenia and died. The LMWH tinzaparin appears clinically to be as effective and safe as enoxaparin in the prophylaxis of deep vein thrombosis after total hip replacement, at the doses used and under the conditions of this study.

 

MissingLinkText

 

 

MissingLinkText

• References

• 1 Hirsh J, Levine MN. Low-molecular-weight heparin. Blood 1992; 79 (01) 1-17.
• 2 Barrowcliffe TW, Johnson EA, Thomas DP. Low molecular weight heparin. Eds John Wiley, Chichester; 1992
• 3 Nurmohamed MT, Rosendaal FR, Büller HR. et al Low-molecular-weight heparin versus standard heparin in general and orthopaedic surgery: a meta-analysis. Lancet 1992; 340: 152-6.
• 4 Leizorovicz A, Haugh MC, Chapuis FR. et al Low-molecular-weight heparin in prevention of perioperative thrombosis. BMJ 1992; 305: 913-20.
• 5 Jorgensen LN, Wille-Jorgensen P, Hauch O. Prophylaxis of postoperative thromboembolism with low molecular weight heparins. Br J Surg 1993; 80: 689-704.
• 6 Mätzsch T, Bergqvist D, Fredin H. et al Comparison of the thromboprophylactic effect of a low-molecular-weight heparin versus dextran in total hip replacement. Thromb Haemorrh Disorders 1991; 3 (01) 25-9.
• 7 Lassen MR, Borris LC, Christiansen HM. et al Prevention of thromboembolism in 190 hip arthroplasties. Comparison of LMW heparin and placebo. Acta Orthop Scand 1991; 62 (01) 33-8.
• 8 Hull R, Raskob G, Pineo G. et al A comparison of subcutaneous low-molecular-weight heparin with warfarin sodium for prophylaxis against deep-vein thrombosis after hip or knee implantation. N Engl J Med 1993; 329: 1370-6.
• 9 Planes A, Vochelle N, Mazas F. et al Prevention of postoperative venous thrombosis: a randomized trial comparing unfractionated heparin with low-molecular-weight heparin in patients undergoing total hip replacement. Thromb Haemost 1988; 60: 407-10.
• 10 The Danish Enoxaparin Study Group. Low-molecular-weight heparin (Enoxaparin) vs Dextran 70: the prevention of postoperative deep vein thrombosis after total hip replacement. Arch Intern Med 1991; 151: 1621-4.
• 11 Planes A, Vochelle N, Fagola M. et al. Prevention of deep vein thrombosis after total hip replacement. the effect of low-molecular-weight heparin with spinal and general anaesthesia. J Bone Joint Surg 1991; 73: B418-22.
• 12 Spiro TE, Johnson GJ, Christie MJ. et al Efficacy and safety of enoxaparin to prevent deep venous thrombosis after hip replacement surgery. Ann Intern Med 1994; 121 (02) 81-9.
• 13 Planes A. Comparison of antithrombotic efficacy and haemorrhagic side-effects of Clivarin versus enoxaparin in patients undergoing total hip replacement surgery. Blood Coagul Fibrinolysis 1993; 4 (Suppl. 01) suppl S33-5.
• 14 Eriksson I B, Wille-Jorgensen P, Kälebo P. et al. A comparison of recombinant hirudin with a low-molecular-weight heparin to prevent thromboembolic complications after total hip replacement. N Engl J Med 1997; 337: 1329-35.
• 15 Elalamy I, Potevin F, Lecrubier C. et al A fatal low-molecular-weight heparin associated thrombocytopenia after hip surgery: possible usefulness of PF4-heparin Elisa test. Blood Coagul and Fibrinolysis 1996; 7: 665-71.
• 16 Bounameaux H, Prins TR, Schmitt HE. et al. Venography of the lower limbs. Pitfalls of the diagnostic standard. Invest Radiol 1992; 27: 1009-11.
• 17 Lensing AWA, Büller HR, Prandoni P. et al. Contrast venography, the gold standard for the diagnosis of deep-vein thrombosis: improvement in observer agreement. Thromb Haemost 1992; 67: 8-12.
• 18 Wille-Jorgensen P, Borris L, Jorgensen N. et al. Phlebography as the gold standard in thromboprophylactic studies? A multicenter interobserver variation study. Acta Radiologica 1992; 33: 24-8.
• 19 Couson F, Bounameaux C, Didier D. et al. Influence of variability of interpretation of contrast venography for screening of postoperative deep venous thrombosis on the results of a thromboprophylactic study. Thromb Haemost 1993; 70 (04) 573-5.
• 20 Warkentin TE, Levine MN, Hirsh J. et al Heparin-induced thrombocytopenia in patients treated with low-molecular-weight heparin or unfractionated heparin. N Engl J Med 1995; 332: 1330-5.
• 21 Warkentin TE, Chong BH, Greinacher A. Heparin-induced thrombocytopenia: towards a consensus. Thromb Haemost 1998; 79: 1-7.