RE-ALIGN
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
65.0% male
N = 252
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).
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 MI
8%
2%
8.0 %
6.0 %
4.0 %
2.0 %
0.0 %
Dabigatran
Warfarin
No significant
difference ↔
No significant difference in death, stroke, systemic embolism, or MI (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 MI (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 MI.
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.
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