Abstract

Direct Oral Anticoagulants, Bleeding Risk in Patients with Atrial Fibrillation, CHADS2 ≥ 3 or HAS-BLED ≥ 3

Acanfora D, Casucci G, Ciccone MC, Scicchitano P, Montefusco G, Lanzillo A, Acanfora C and Lanzillo B

To evaluated the safety of direct oral anticoagulants as compared to warfarin in a subgroup of patients with atrial fibrillation (AF) who should undergo antithrombotic therapy such as patients with CHADS2 score ≥ 3. We evaluated the incidence of major bleeding in patients with AF and CHADS2 score ≥ 3 in the RE-LY, ROCKET-AF, ARISTOTLE, and ENGAGE studies. Also we evaluated the incidence of major bleeding in patients at higher hemorrhagic risk (HAS-BLED ≥ 3). Data was derived from eleven studies whose results came from the pivotal trials. Our aim was to propose a critical debate on the collected data.

There were some striking differences between the 4 considered studies: a high percentage of bleeding in the subpopulation at high risk of stroke or systemic embolism or at high risk of bleeding. Some studies reported a higher frequency of bleeding in the warfarin arm. The excess in the bleeding rate in the warfarin group was likely to be associated with Asian ethnicity as Asian patients often have higher warfarin sensitivity. Asian patients may require lower initiation and maintenance doses of warfarin. Careful evaluation of patients in need for anticoagulation is essential for the prescription of these drugs and the extension of global use.