Regular ArticleDabigatran versus enoxaparin for prevention of venous thromboembolism after hip or knee arthroplasty: A pooled analysis of three trials
Section snippets
Data sources
RE-MOBILIZE, RE-MODEL and RE-NOVATE were prospective double-blind, double-dummy, randomized multicenter non-inferiority studies in adults aged at least 18 years who were scheduled for primary elective total hip or knee arthroplasty (Table 1). Patient characteristics were generally similar across the three trials, although in RE-MOBILIZE there was a higher proportion of non-Caucasian patients (4% black, 10% Asian and 12% Hispanic patients) (Table 2) [5], [6], [7].
The three trials had identical
Patients
Overall 8,210 patients were randomized between November 2004 and June 2006; 8,135 were treated (evaluable for safety), and 8,087 patients were operated and treated with oral dabigatran (n = 5,392) or subcutaneous enoxaparin (n = 2,695) (Supplementary Table 1). A further 1,887 (23.3%) patients were excluded from the mITT population mainly because bilateral venography was not performed (usually declined by the patient) or the venograms were considered indeterminate by the venography adjudication
Discussion
This pooled analysis of three major trials (RE-MOBILIZE, RE-MODEL, and RE-NOVATE) was designed to evaluate the effect of dabigatran on clinically relevant efficacy and safety outcomes. The findings show that dabigatran was as effective as enoxaparin in decreasing the risk of major VTE and VTE-related mortality. The common RD estimates were -0.2% (95% CI -1.3% to 0.9%) for 220 mg dabigatran and 0.5% (95% CI -0.6% to 1.6%) for 150 mg dabigatran. Although no non-inferiority margin was pre-specified,
Author Contributions
All authors (except Andreas Clemens) were members of the RE-MOBILIZE, RE-MODEL or RE-NOVATE steering committees. The authors meet criteria for authorship as recommended by the International Committee of Medical Journal Editors (ICMJE) and were fully responsible for all content and editorial decisions, and were involved at all stages of manuscript development.
Conflict of interest statement
Andreas Clemens, Stefan Hantel and Janet M Schnee are employees of Boehringer Ingelheim. All other authors received honoraria as members of the trial steering committees.
Acknowledgements
The authors thank the members of the data and safety monitoring board, the investigators, study coordinators and radiologists who participated in the trials, as listed in the original publications [5], [6], [7]. We thank Herbert Noack for assistance with the statistical analysis. All trials were sponsored by Boehringer Ingelheim (BI). This work was supported by BI. The authors received no compensation related to the development of the manuscript. Editorial assistance was provided, with funding
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