Dabigatran as an alternative to warfarin for the prevention of thromboembolism in atrial fibrillation

Atrial fibrillation (AF) is an independent major risk factor for stroke, and antithrombotic therapy is here recommended according to stratification of the patient's thromboembolic and hemorrhagic risks. Recent evidence is leading to the replacement of vitamin K antagonists, the efficacy of which in preventing stroke in AF is well established, with better tolerated and more manageable new anticoagulant drugs, with a lower risk of intracranial bleeding, no clear interactions with food, fewer interactions with medications, and no need for frequent laboratory monitoring and dose adjustments. Among new anticoagulants, dabigatran etexilate is a direct, competitive inhibitor of thrombin. It was evaluated for patients with AF in the RE-LY trial, showing lower rates of stroke and systemic embolism at a dose of 150 mg twice daily with similar rates of major hemorrhage compared with warfarin; and non-inferiority compared with warfarin for the prevention of stroke and systemic embolism at a dose of 110 mg twice daily, with lower rates of major bleeding. Beside dabigatran, oral factor Xa inhibitors are also emerging for the prevention of thromboembolic events in AF. Despite the obvious advantages of these new oral anticoagulants over vitamin K antagonists, further information is still needed on how to prioritize the patients deriving the greatest benefit from these novel agents on the basis of patient characteristics or drug pharmacokinetics. There is also a need for assessing their long-term efficacy and safety over decades in the real-world setting.