Abstract
BackgroundTwo phase 3 trials compared 28–35 days of treatment with oral dabigatran 220 mg or 150 mg (RE-NOVATE) or 220 mg (RE-NOVATE II) once daily with subcutaneous enoxaparin 40 mg once daily for prevention of venous thromboembolism (VTE) after elective total hip arthroplasty.MethodsThis prespecified pooled analysis compared the outcomes for the dabigatran 220 mg dose with enoxaparin, which included 4,374 patients. Total VTE (venographic and symptomatic) plus all-cause mortality (primary efficacy), major VTE (proximal deep vein thrombosis [DVT] or non-fatal pulmonary embolism) plus VTE-related death, and bleeding events were evaluated. Efficacy analysis was based on the modified intention-to-treat (ITT) population and safety analysis was based on all treated patients. The common risk difference (RD) for dabigatran versus enoxaparin was estimated using a fixed effects model.ResultsTotal VTE and all-cause mortality occurred in 6.8 % (114/1,672) and 7.7 % (129/1,682) (RD:–0.8 %, 95 % confidence interval [CI] –2.6 to 0.9) for dabigatran and enoxaparin, respectively. Major VTE plus VTE-related mortality occurred in 2.7 % (46/1,714) and 4.0 % (69/1,711) (RD: –1.4 %, 95 % CI –2.6 to –0.2) of patients receiving dabigatran 220 mg and enoxaparin, respectively. Major bleeding occurred in 1.7 % (37/2,156) and 1.3 % (27/2,157) (RD: 0.5 %, 95 % CI –0.2 to 1.2), for dabigatran and enoxaparin respectively.ConclusionsExtended prophylaxis with oral dabigatran 220 mg once daily was as effective as enoxaparin 40 mg once daily in reducing the risk of total VTE and all-cause mortality after total hip arthroplasty, with a similar bleeding profile. The clinically relevant outcome of major VTE and VTE-related death was significantly reduced with dabigatran versus enoxaparin.Trial registrationNCT00657150 and NCT00168818
Highlights
Two phase 3 trials compared 28–35 days of treatment with oral dabigatran 220 mg or 150 mg (RE-NOVATE) or 220 mg (RE-NOVATE II) once daily with subcutaneous enoxaparin 40 mg once daily for prevention of venous thromboembolism (VTE) after elective total hip arthroplasty
Study population A total of 4,374 patients were randomized across 20 countries between December 2004 and May 2009, of whom 4,313 were treated and evaluable for safety. 4,272 patients were operated upon and treated with oral dabigatran 220 mg (n = 2,138) or subcutaneous enoxaparin 40 mg (n = 2,134) (Fig. 1)
A further 918 (21.5 %) patients were excluded from the modified intention-to-treat (mITT) population, as usual in all studies with venography, mainly because bilateral venography was not performed or the venograms were considered indeterminate by the venography adjudication committee
Summary
Two phase 3 trials compared 28–35 days of treatment with oral dabigatran 220 mg or 150 mg (RE-NOVATE) or 220 mg (RE-NOVATE II) once daily with subcutaneous enoxaparin 40 mg once daily for prevention of venous thromboembolism (VTE) after elective total hip arthroplasty. Two previously reported phase 3 trials (RE-NOVATE and RE-NOVATE II) [1, 2] compared the efficacy and safety of dabigatran (220 mg or 150 mg once daily, started 1–4 h after surgery) with enoxaparin (40 mg once daily, started at least 12 h before surgery) for the prevention of venous thromboembolism (VTE) and all-cause mortality after elective total hip arthroplasty. In both of these studies, the noninferiority of dabigatran 220 mg over enoxaparin 40 mg for the primary efficacy endpoint, total VTE (the composite of symptomatic and asymptomatic venographic deep vein thrombosis [DVT], non-fatal pulmonary embolism [PE]) plus all-cause mortality, was demonstrated. The prespecified pooled analysis of these two studies was planned to compare the effect of dabigatran 220 mg and enoxaparin 40 mg once daily on the primary efficacy endpoint of total VTE and all-cause mortality in patients undergoing total hip arthroplasty
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