Liviu Klein, MD, MS
Is dabigatran noninferior to warfarin for reducing stroke and systemic embolism in patients with atrial fibrillation (AF)?
Randomized, controlled, noninferiority trial (Randomized Evaluation of Long-Term Anticoagulation Therapy [RE-LY] study). ClinicalTrials.gov NCT00262600.
Blinded for dabigatran dose (patients); blinded for dabigatran and warfarin (adjudication committee).*
Median 2 years.
951 clinical sites in 44 countries.
18 113 patients (mean age 71 y, 64% men) who had AF at screening or within 6 months and risk for stroke (past stroke or transient ischemic attack, left ventricular ejection fraction < 40%, heart failure symptoms within 6 months [New York Heart Association class ≥ II], ≥ 75 years of age, or 65 to 74 years of age plus diabetes mellitus, hypertension, or coronary artery disease). Exclusion criteria included severe heart-valve disorder, stroke within 14 days or severe stroke within 6 months, conditions that increase risk for hemorrhage, creatinine clearance < 30 mL/min, active liver disease, and pregnancy.
Dabigatran, 110 mg (n = 6015) or 150 mg (n = 6076) twice daily, or warfarin adjusted to an international normalized ratio (INR) of 2.0 to 3.0 (n = 6022).
Composite of stroke or systemic embolism. Other outcomes included major hemorrhage, stroke, and death.
The main results are in the Table. Dabigatran, 150 mg twice daily, reduced stroke or systemic embolism more than warfarin or dabigatran, 110 mg twice daily (Table).
In patients with atrial fibrillation, dabigatran, 150 mg twice daily, reduced risk for stroke or systemic embolism more than warfarin and had similar rates of major hemorrhage.
Dabigatran 110 mg (D110) vs 150 mg (D150) vs warfarin in atrial fibrillation†
†Abbreviations defined in Glossary. RRR, RRI, NNT, NNH, and CI calculated from data in article.
‡P < 0.001 for noninferiority (upper 97.5% CI for relative risk < 1.46).
Klein L. Higher-dose dabigatran reduced stroke, but not major hemorrhage, more than warfarin in atrial fibrillation. Ann Intern Med. ;152:JC1–2. doi: 10.7326/0003-4819-152-2-201001190-02002
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Published: Ann Intern Med. 2010;152(2):JC1-2.
Cardiology, Neurology, Rhythm Disorders and Devices, Stroke.
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