RE-MOBILIZE

Oral thrombin inhibitor dabigatran etexilate versus North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty (2009)

Condition

Prophylaxis for VTE after total knee replacement

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Objective

To compare the efficacy and safety of dabigatran and enoxaparin in the prevention of venous thromboembolism after total knee replacement

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Trial design

Randomized, double-blind non-inferiority phase III study
Active treatment: dabigatran 150 mg (n=871) or 220 mg (n=857) p.o. once daily, starting 6–12 hours after surgery with half dose on the first day, for 12–15 days; placebo injections as in control treatment
Control treatment: enoxaparin 30 mg s.c. twice daily, starting 12–24 hours after surgery, for 12–15 days; placebo tablets as in active treatment (n=868)

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Endpoints

Primary efficacy endpoint: composite of total VTE events (symptomatic or venographic DVT and/or symptomatic PE) and all-cause mortality during treatment
Secondary efficacy endpoints: composite of major VTE (proximal DVT, PE, and VTE-related mortality); proximal DVT; incidence of total VTE and allcause mortality during follow-up
Primary safety endpoint: major bleeding
Secondary safety endpoints: clinically relevant non-major bleeding and minor bleeding

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Trial participants

2615 patients (mean age 66 years), scheduled for elective total knee replacement

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Results

Efficacy outcome: In patients with evaluable efficacy outcome (n=1896), the primary endpoint (all VTE and all-cause mortality) occurred in 219 of 649 patients (33.7%) given 150 mg dabigatran, in 188 of 604 patients (31.1%) given 220 mg dabigatran and in 163 of 643 patients (25.3%) given enoxaparin 
Safety outcome: In the study population of 2596 patients major bleeding occurred in 5 of 871 patients (0.6%) receiving 150 mg dabigatran, in 5 of 857 patients (0.6%) receiving 220 mg dabigatran and in 12 of 868 patients (1.4%) receiving enoxaparin. During the treatment period comparable rates of clinically relevant non-major bleeding events in the three groups were observed

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Summary

Efficacy: Both dabigatran dosage regimens failed to show statistical noninferiority to enoxaparin, as the combined incidence of VTE and death was slightly higher in patients treated with dabigatran
Safety: In patients receiving enoxaparin, major bleeding events were more frequent. The rate of clinically relevant non-major bleeding events was comparable in all three study groups

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Reference

Ginsberg JS, Davidson BL, Comp PC, Francis CW, Friedman RJ, Huo MH, Lieberman JR, Muntz JE, Raskob GE, Clements ML, Hantel S, Schnee JM, Caprini JA for the RE-MOBILIZE Writing Committee. Oral thrombin inhibitor dabigatran etexilate vs North American enoxaparin regimen for prevention of venous thromboembolism after knee arthroplasty surgery.
J Arthroplasty 2009;24:1-9

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Corresponding author

Bruce L Davidson, MD, MPH. 30 Weill Cornell Medical College-Qatar. 575 Lexington Avenue, Suite 670, New York, NY 10022, USA, e-mail: brucedavidson@pobox.com

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