Comparison of idrabiotaparinux with vitamin K antagonists for prevention of thromboembolism in patients with atrial fibrillation: the Borealis-AF study.
J Thromb Haemost. 2014 Mar 5;
Authors: Buller HR, Halperin J, Hankey GJ, Pillion G, Prins MH, Raskob GE
BACKGROUND: Idrabiotaparinux, a long acting, inhibitor of factor Xa was shown to be effective in the treatment of patients with venous thromboembolism.
OBJECTIVE: To assess non-inferiority for efficacy of idrabiotaparinux versus warfarin in patients with atrial fibrillation (AF) at risk of stroke and systemic embolism (SE). Bleeding was also assessed.
METHODS: This randomised, double-blind, trial, enrolled patients with ECG-documented AF. Idrabiotaparinux was administered weekly by subcutaneous injection, and warfarin daily with dose adjustment to maintain the International Normalised Ratio (INR) between 2.0 and 3.0. Each idrabiotaparinux injection was 3 mg for the first 7 weeks, followed by 2 mg thereafter, except in patients with a creatinine clearance 30-50 mL /min or age 75 years or older. They received 1.5 mg after the first 7 weeks. The efficacy outcome was the composite of all fatal or non-fatal strokes and SE. The safety outcome was clinically relevant bleeding (major and clinically relevant non-major bleeding).
RESULTS: The study was terminated prematurely by the sponsor for strategic/commercial, not scientific, reasons, with 39% of the planned number of patients included and an average duration of treatment of 240 days. Of the 1886 idrabiotaparinux recipients, 20 developed stroke or SE (1.5% per year), whereas this occurred in 22 of the 1887 warfarin patients (1.6% per year; hazard ratio 0.98; 95% confidence interval [C.I.] 0.49-1.66). The annual incidence of bleeding was 6.1% in the idrabiotaparinux and 10.0% in the warfarin group (hazard ratio 0.61; 95% C.I. 0.46-0.81).
CONCLUSION: If anything, despite its early termination the idrabiotaparinux regimen studied suggested a comparable efficacy to dose-adjusted warfarin, with a lower bleeding risk. This article is protected by copyright. All rights reserved.
PMID: 24597472 [PubMed - as supplied by publisher]