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Abstract

Randomized Evaluation of Long-Term Anticoagulation (RE-LY)
Why is this study important and noteworthy?
Warfarin is currently the gold standard for stroke prevention in patients with atrial fibrillation. Therapy with Warfarin requires frequent International Normalized Ratio (INR) monitoring due to its low therapeutic index. Furthermore, multiple food and drug interactions lead to non-compliance and frequent dose adjustment.
Dabigatran, the active form of the prodrug Dabigatran etexilate, is a competitive inhibitor of thrombin. This new anticoagulant does not require frequent monitoring and had been evaluated in a pilot trial with promising results.
RE-LY was a randomized study which tested two fixed doses of Dabigatran (110 and 150 mg twice daily) given in a blinded manner, with open label use of Warfarin in patients with atrial fibrillation and an increased risk of stroke.
Who were the participants?
A total of 18,113 patients from 951 clinical centers across 44 countries were recruited for this non-inferiority trial and followed for a median duration of 2 years. There was a fair representation from Asia, with patients being recruited from India, China, Korea and Japan. All patients had documented atrial fibrillation on electrocardiography at the time of screening or within 6 months beforehand and, a risk of stroke. 63.6% of the patients were men and the mean age was 71 years.
What was the intervention?
Patients were assigned randomly to one of three treatment groups. Two groups received either 110 mg or 150 mg twice daily dose of Dabigatran in a blinded fashion. The third group received Warfarin in 1, 3 or 5 mg tablets adjusting to an International Normalized Ratio (INR) of 2.0 to 3.0 in an unblinded fashion. Concomitant use of Aspirin at a dose of