Summary

Preclinical studies in porcine mechanical heart valve models suggested that dabigatran may effectively prevent valve thrombosis [Schomburg JL et al. J Invest Surg 2012]. These results led to A Randomized, Phase 2 Study to Evaluate the Safety and Pharmacokinetics of Oral Dabigatran Etexilate in Patients After Heart Valve Replacement [RE-ALIGN; Eikelboom JW et al. N Engl J Med 2013]. The aim of the RE-ALIGN trial was to evaluate a dosing algorithm of dabigatran based on the RE-LY study to prevent thromboembolic complications in patients with mechanical heart valve replacement.