Meta regression analysis to indirectly compare dalteparin to enoxaparin for the prevention of venous thromboembolic events following total hip replacement (original) (raw)
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Clinical and Applied Thrombosis/Hemostasis, 2012
Background: Patients undergoing elective total hip replacement (THR) surgery are at an increased risk for venous thromboembolic events (VTEs). Dalteparin and enoxaparin are recommended as thromboprophylaxis for at least 10 days in these patients. Even though both agents have proven clinical effectiveness through placebo controlled studies, there have been no head to head trials to assess comparative effectiveness. Indirect statistical techniques were used to compare safety and efficacy between dalteparin and enoxaparin following THR surgery. randomized trials evaluating dalteparin or enoxaparin prophylaxis in THR patients. In trials where a common control was used (e.g. placebo), indirect statistical comparisons between dalteparin and enoxaparin were performed using meta regression analysis with active drug as the primary independent variable. Results: A total of nine placebo controlled enoxaparin (n = 5) and dalteparin (n = 4) trials met the inclusion criteria. THR patients treated with enoxaparin or dalteparin had a 50% VTE risk reduction compared to the placebo control (RR = 0.50, p < 0.001). This benefit was achieved without a significant increase in the risk for major bleeds (RR = 1.19, p = 0.76), heparin induced thrombocytopenia (HIT) (RR = 1.13, p = 0.83) or death (RR = 0.72, p = 0.59). The indirect comparison was not able to find significant differences between enoxaparin and dalteparin in terms of VTEs (p = 0.36), major bleeds (p = 0.45), HIT (p = 0.48) and death (p = 0.86). Conclusions: The findings suggested comparable safety and efficacy between dalteparin and enoxaparin in TKR patients. Therefore, treatment decisions should be based on other considerations, such as patient or physician preference, ease of administration and cost.
Biomedical Research and Therapy, 2021
Introduction: Our research aims to evaluate the effectiveness of thromboprophylaxis using enoxaparin in patients undergoing hip replacement. Methods: A retrospective cohort study was conducted based on medical records of patients aged 40 years and older undergoing hip replacement. Exclusion criteria included patients who had used anticoagulants to prevent other diseases, patients with a history of chronic renal failure, liver failure, cancer or allergy to anticoagulants, and patients with indicated mechanical prophylaxis. In our study, 65 patients were randomized into 2 groups - the control group and the venous thromboembolism (VTE) prophylaxis group (receiving subcutaneous enoxaparin 40 mg daily for 7 - 14 days). Preventive effectiveness was evaluated based on the comparison of VTE incidence after surgery between the groups. Results: In our study, most of the patients were over 60 years old (79.2%). No case of pulmonary embolism was recorded. There were 11 patients in the control g...
Archives of Orthopaedic and Trauma Surgery, 2006
Introduction: We compared the efficacy and safety of standard heparin to that of low molecular weight heparin (Enoxaparin) in 100 hip replacement patients. Materials and methods: A total of 100 patients who underwent total hip replacement surgery were randomised to receive a study medication. Enoxaparin was administered to 50 patients (prophylaxis with subcutaneous injection of 40 mg of Enoxaparin daily was initiated 12 h preoperatively), and heparin (subcutaneous standard heparin initiated 8 h preoperatively on a dose of 5,000 IU and continued to 15,000 IU per day in three equal dosages every 8 h) was given to 50 patients. Each treatment was continued until the patients were discharged from the hospital. They were made to undergo lower extremity duplex ultrasonography for deep vein thrombosis before discharge and discontinued from medication if no pathology was found. The primary parameter to determine the efficacy was the prevalence of venous thromboembolic disease. The primary parameter to determine safety was the prevalence of major bleeding. Results: Two patients in the heparin group developed DVT, which was detected by routine duplex ultrasonography at the end of hospitalisation, and two patients in the exoparine group were detected with late DVT during the postoperative period of 6 weeks. Seven patients had minor and major bleeding in both the groups. Six patients in the heparin group discontinued from medication because of hepatic, renal dysfunctions, and serious discharges from the wound. Conclusion: Enoxaparin is as safe and as effective as standard heparin in total hip replacement surgery.
2011
Background: Due to a high risk of thromboembolism in patients undergoing major orthopaedic surgery it has become standard practice to give thromboprophylactic treatment to these patients. Pharmaceutical interventions with or without addition of mechanical methods are recommended. • This project, commissioned by Helse Bergen HF Ortopedisk klinikk, examined thromboprophylaxis with rivaroxaban or dabigatran compared with low-molecular weight heparins (LMWH, i.e. enoxaparin and dalteparin) with regard to effi cacy, safety and cost-effectiveness in patients undergoing elective total hip or knee replacement surgery. • We conducted a systematic review of the literature and made cost-effectiveness analyses based on a model that calculated quality-adjusted life years and life time costs. Main fi ndings: • We did not fi nd statistically signifi cant differences between dabigatran and enoxaparin for mortality, pulmonary embolism, deep vein thrombosis or major bleeding. The quality of the evidence ranged from very low to moderate. • For rivaroxaban compared with enoxaparin we found statistically a signifi cant reduction in deep vein thrombosis,
Journal of Thrombosis and Haemostasis, 2003
In a randomized trial on the effect of dalteparin for 5 weeks after HRS we evaluated hemostatic variables in plasma sampled before and 1, 6 and 35 days postoperatively. In 218 patients we found that prothrombin fragment 1 2 (F1 2), thrombin±antithrombin complexes (TAT), D-dimer and ®brinogen were signi®cantly higher on day 35 as compared with baseline values in the placebo group (P < 0.001 for all). The same pattern was found in the dalteparin group, but with signi®cantly lower values for F1 2, TAT and D-dimer. In patients in the placebo group with venographically proven deep vein thrombosis (DVT) on day 35 (33%), signi®cantly higher values were found for F1 2, TAT and D-dimer than in patients without DVT. Patients in the highest quartile of D-dimer (>2850 ng mL À1 ) had an odds ratio for the presence of DVT of 24.0 when compared with patients in the lowest quartile (<1625 ng mL À1 ). It is concluded that a substantial hypercoagulability is sustained until day 35 after HRS, signi®cantly reduced with prolonged administration of dalteparin.
Thrombosis and haemostasis, 1988
A double blind randomized trial comparing subcutaneous enoxaparin (40 mg once daily) with standard unfractionated calcium heparin administered at a dose of 5,000 units every 8 hours in patients undergoing elective hip replacement has been performed. Treatment regimens began 12 hours preoperatively with enoxaparin, 2 hours preoperatively with standard unfractionated calcium heparin, and were continued for 15 days or until discharge. Venography was performed in all patients. Two hundred thirty-seven patients were included in the study: 113 received unfractionated heparin and 124 received enoxaparin. The incidence of proximal deep vein thrombosis was reduced from 18.5% in the unfractionated heparin group to 7.5% in the enoxaparin group (p = 0.014), and the incidence of total deep vein thrombosis was similarly reduced from 25% to 12.5% (p = 0.03). There were two major bleeding episodes and one minor bleed in the enoxaparin group compared to two minor bleeds in the unfractionated heparin...
Annals of Internal Medicine, 2013
Background: The role of aspirin in thromboprophylaxis after total hip arthroplasty (THA) is controversial. Objective: To compare extended prophylaxis with aspirin and dalteparin for prevention of symptomatic venous thromboembolism (VTE) after THA. Design: Multicenter randomized, controlled trial with a noninferiority design based on a minimal clinically important difference of 2.0%. Randomization was electronically generated; patients were assigned to a treatment group through a Web-based program. Patients, physicians, study coordinators, health care team members, outcome adjudicators, and data analysts were blinded to interventions. (Current Controlled Trials: ISRCTN11902170) Setting: 12 tertiary care orthopedic referral centers in Canada. Patients: 778 patients who had elective unilateral THA between 2007 and 2010. Intervention: After an initial 10 days of dalteparin prophylaxis after elective THA, patients were randomly assigned to 28 days of dalteparin (n ϭ 400) or aspirin (n ϭ 386). Measurements: Symptomatic VTE confirmed by objective testing (primary efficacy outcome) and bleeding. Results: Five of 398 patients (1.3%) randomly assigned to dalteparin and 1 of 380 (0.3%) randomly assigned to aspirin had VTE (absolute difference, 1.0 percentage point [95% CI, Ϫ0.5 to 2.5 percentage points]). Aspirin was noninferior (P Ͻ 0.001) but not superior (P ϭ 0.22) to dalteparin. Clinically significant bleeding occurred in 5 patients (1.3%) receiving dalteparin and 2 (0.5%) receiving aspirin. The absolute between-group difference in a composite of all VTE and clinically significant bleeding events was 1.7 percentage points (CI, Ϫ0.3 to 3.8 percentage points; P ϭ 0.091) in favor of aspirin. Limitation: The study was halted prematurely because of difficulty with patient recruitment. Conclusion: Extended prophylaxis for 28 days with aspirin was noninferior to and as safe as dalteparin for the prevention of VTE after THA in patients who initially received dalteparin for 10 days. Given its low cost and greater convenience, aspirin may be considered a reasonable alternative for extended thromboprophylaxis after THA.