Key result
Bemiparin cuts post-operative VTE by ~61% versus UFH after elective hip arthroplasty.
Why the study?
Does bemiparin reduce post-operative venous thromboembolism compared to unfractionated heparin in patients undergoing elective hip arthroplasty?
RCT (n=300)
Double-blind
randomised
Does bemiparin reduce post-operative venous thromboembolism compared to unfractionated heparin in patients undergoing elective hip arthroplasty?
Bemiparin is more effective than unfractionated heparin for preventing post-operative venous thromboembolism in patients undergoing elective hip arthroplasty, with a similar safety profile.
Supports bemiparin preference over unfractionated heparin for VTE prophylaxis in elective hip arthroplasty; confirms LMWH superiority in orthopedic surgery.
Summary A randomised, prospective, double-blind trial was performed, to compare the safety and efficacy of a new low-molecular-weight heparin (LMWH) Bemiparin and standard unfractionated heparin (UFH), for the prophylaxis of postoperative venous thromboembolism. 300 patients scheduled to undergo elective hip arthroplasty were included. The principal outcome measures were the incidence of thromboembolic events and bleeding complications. 149 patients received 3,500 anti-Xa IU of bemiparin plus a placebo injection daily and 149 patients received 5,000 IU of UFH twice a day. The two groups were similar with respect to factors likely to affect the risk of developing post-operative venous thromboembolism (VTE) and risk of bleeding events. During the post-operative period, 34 patients developed VTE complications; 9 (7.2%) in the bemiparin group and 25 (18.7%) in the UFH group. VTE in the two groups was statistically significant (OR of 2.96; 95% CI 1.32-6.62 and p = 0.01). There were no significant differences in the frequency of bleeding complications: major bleeding requiring discontinuation of prophylaxis, (OR 1.21; 95% CI 0.36-4.05; p = 1.00), the measured median operative blood loss (p = 0.77) or the median postoperative drain loss (p = 0.97), and the number of patients who developed wound haematoma (OR 0.87; 95% CI 0.31-2.46; p = 1.00). A comparison of coagulation parameters on the preoperative day with post-operative day 2 ± 1, day 6 ± 1 and day of discharge showed a significantly higher AT concentration, anti-factor Xa activity and TFPI levels in the bemiparin group when compared with UFH. This study demonstrates that bemiparin, in a single daily subcutaneous dose of 3,500 anti-Xa IU in high risk patients undergoing hip arthroplasty is more effective than UFH administered twice daily at a dose of 5,000 IU in the prevention of postoperative VTE. Both agents are equally safe. List of participants, their affiliations and current addresses are listed in the appendix on p. 528
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Howes et al. (2000) conducted an RCT in Elective hip arthroplasty (n=300). Bemiparin vs. Unfractionated heparin (UFH) 5,000 IU twice a day was evaluated on Incidence of post-operative venous thromboembolism (VTE) (OR 2.96, 95% CI 1.32-6.62, p=0.01). Bemiparin significantly reduced post-operative venous thromboembolism compared to unfractionated heparin in patients undergoing elective hip arthroplasty (7.2% vs 18.7%; OR 2.96; 95% CI 1.32-6.62; p=0.01).
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