A comparison of dabigatran etexilate with warfarin in patients with mechanical heart valves: The Randomized, phase II study to Evaluate the sAfety and pharmacokinetics of oraL dabIGatran etexilate in patients after heart valve replacemeNt (RE-ALIGN)

Use of Direct Oral Anticoagulants in Patients With Atrial Fibrillation and Valvular Heart Lesions

“…Results of subsequent studies led to revision of the dabigatran (Pradaxa ® ; Boehringer Ingelheim Pharmaceuticals, Inc) product label to recommend against the use of dabigatran in patients with NVAF in the setting of other forms of VHD. In the RE‐ALIGN (Dabigatran Etexilate in Patients With Mechanical Heart Valves; ClinicalTrial.gov NCT01452347) trial, the use of dabigatran in patients with mechanical heart valves was associated with increased rates of thromboembolic and bleeding complications compared with warfarin 24. These findings suggest that DOACs may be used in selected patients with AF who do not have mechanical heart valve prostheses.…”

Current approaches to antithrombotic therapy in patients with cardioembolic stroke

“…Для оценки эффективности дабигатрана этексилата с целью вторичной профилактики ИИ была выделена под-группа из 3623 пациентов с ИИ или ТИА в анамнезе [38,39]. Дабигатрана этексилат назначали не ранее чем через 2 нед после первого ИИ.…”

The Discovery of Dabigatran Etexilate

“…Valve thrombus was observed in all groups; however there was decreased incidence of bleeding and a significant mortality benefit in the dabigatran-treated group vs. warfarin. Dabigatran's effects in the setting of mechanical valve replacement was investigated in the dose-finding RE-ALIGN phase II study (Van de Werf et al, 2012), however the study was discontinued because interim analysis showed an increased incidence of thromboembolic events compared to warfarin. Therefore dabigatran is contraindicated in patients with mechanical prosthetic valves (FDA Drug Safety Communication, 2012).…”