PURPOSE: Deep Vein Thrombosis (DVT) and Venous Thrombo Embolism (VTE) are major concerns for patients undergoing hip or knee replacement surgery as despite prophylaxis the event rate is 20%. Dabigatran etexilate, an oral direct thrombin inhibitor, is being studied in the prevention of DVT and is shown to reduce the event rates in these patients. We have assessed the efficacy of Dabigatran in prevention of DVT and VTE compared to Enoxaparin in patients undergoing hip or knee replacement surgery.
METHODS: Randomized control trials that included patients undergoing hip or knee replacement surgery in which Dabigatran was used alone or compared with Enoxaparin therapy were included for the meta-analysis. Systematic review of literature was performed with relevant terms in MEDLINE and OVID search engines. Chi-square test was used to assess inter-study heterogeneity. Relative risk of DVT and VTE were assessed by weighted mean difference using Revmans software 4.2.10 version. Results were computed using 95% confidence intervals and were considered significant with double sided alpha error <0.05.
RESULTS: Four trials (N=4128) fulfilled the inclusion criteria for the study. There was no difference in the incidence of VTE among patients treated with either Dabigatran or Enoxaparin. The relative risk VTE with Dabigatran was 1.01 (CI 0.9 –1.14, 95%) which is not significantly different from Enoxaparin. (Figure 1) Dabigatran was better than Enoxaparin in prevention of DVT in same patient group (RR = 0.72 CI 0.55–0.94) (Figure 2).
CONCLUSION: Dabigatran in a dose of 150 mg or 220 mg is as effective as Enoxaparin in prevention of VTE and better than Enoxaparin in prevention of DVT for patients undergoing knee or hip replacement surgery. Safety profile of Dabigatran is also similar to Enoxaparin with rates of major bleeding and minor bleeding similar to Enoxaparin.
CLINICAL IMPLICATIONS: Dabigatran can prove to be a good alternative to Enoxaparin. Dabigatran do not require monitoring or dose adjustment and offer potential for prophylaxis against VTE and DVT after total knee or hip replacement surgery.
DISCLOSURE: Anil Patel, No Financial Disclosure Information; No Product/Research Disclosure Information