RE-ALIGN
Dabigatran versus Warfarin in Patients with Mechanical Heart Valves
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 252 patients with a mechanical aortic or mitral valve, dabigatran led to more thromboembolic events and major bleeding compared with warfarin.
N
252
Design
Phase II, open-label, dose-validation — stopped early
Endpunkt
Trough plasma dabigatran level over 12 weeks (thromboembolism/valve thrombosis/bleeding were secondary)
Relevanz
2
ErgebnisStroke 5 % vs 0 %; major bleed 4 % vs 2 %. Trial halted for harm.
Eikelboom JW, et al. N Engl J Med. 2013;369(13):1206-1214. 10.1056/NEJMoa1300615
Diskussion & Kritik
Confirms: NOACs are not interchangeable with VKAs for mechanical valves. Warfarin remains the only validated agent; INR targets depend on valve type & position.