6/29/23, 12:43 AM RE-ALIGN Pathway Feedback Search Clinical Topics Home Studies RE ALIGN RE ALIGN Disease Disease Disease Aortic regurgitation Aortic stenosis Mitral regu Trial question What is the effect of dabigatran in patients with mechanical heart valves? Study design Multi-center Open label RCT Population Characteristics of study participants 35.0% female N = 252 65.0% male 252 patients (89 female, 163 male) Inclusion criteria: patients who had undergone aortic or mitral valve replacement within the past 7 days and those who had undergone such replacement at least 3 months earlier Key exclusion criteria: previous prosthetic heart valve replacement, aortic root replacement, replacement of ascending aorta, concomitant bioprosthetic valve replacement, complex congenital heart abnormality, acute coronary syndrome within one month, uncontrolled hypertension, or recent emergency surgery Interventions N=168 dabigatran (150, 220, or 300 mg BID, adjusted to obtain a trough plasma level of at least 50 ng/mL) https://web.pathway.md/studies/reclzVrykLDLeUr98 1/2 6/29/23, 12:43 AM RE-ALIGN Pathway N=84 warfarin (adjusted to obtain an INR of 2 to 3 or 2.5 to 3.5 on the basis of thromboembolic risk) Primary outcome Death, stroke, systemic embolism, or myocardial infarction 8.0 % 8 6.0 % 4.0 % 2.0 % 2 No significant difference 0.0 % Dabigatran Warfarin No significant difference in death, stroke, systemic embolism, or myocardial infarction (8% vs. 2%; HR 3.37, 95% CI 0.76 to 14.95) Secondary outcomes No significant difference in death, stroke, TIA, systemic embolism, or myocardial infarction (9% vs. 5%; HR 1.94, 95% CI 0.64 to 5.86) Safety outcomes No significant differences in major bleeding (4% vs. 2%, p=0.48) and major bleeding with pericardial location (4% vs. 2%, p=0.48). Significant differences in any bleeding (27% vs. 12%, p = 0.01). Conclusion In patients who had undergone aortic or mitral valve replacement within the past 7 days and those who had undergone such replacement at least 3 months earlier, dabigatran was inferior to warfarin with respect to death, stroke, systemic embolism, or myocardial infarction. Reference Eikelboom JW, Connolly SJ, Brueckmann M et al. Dabigatran versus warfarin in patients with mechanical heart valves. N Engl J Med. 2013 Sep 26;369(13):1206-14. Open reference URL https://web.pathway.md/studies/reclzVrykLDLeUr98 2/2