Bleeding risk and major adverse events in patients with previous ulcer on oral anticoagulation therapy

Bleeding is the major concern for patients receiving oral anticoagulation therapy (OAT), especially those with histories of gastrointestinal ulcer. The aim of this study was to evaluate the efficacy and safety of OAT in patients with nonvalvular atrial fibrillation with histories of ulcer. A composite end point, including major adverse cardiac events or major bleeding, was compared between patients with AF with previous ulcers who were (OAT+; n = 200) and were not (OAT- n = 230) receiving OAT. During the follow-up period of 3.3 ± 2.7 years, 28 (14%) and 66 (29%) OAT+ and OAT- patients, respectively, had major adverse cardiac events (p = 0.001). Major bleeding occurred in 46 OAT+ patients (23%) and 25 OAT- patients (11%) (p = 0.001). There was no significant difference in the composite end point between OAT+ and OAT- patients (29% vs 36%, p = 0.08). The incidence of major bleeding was significantly lower, decreasing from 30% to 14%, when OAT began after endoscopic confirmation of ulcer healing (p = 0.02). OAT+ patients who achieved time in the therapeutic range <60% for international normalized ratio (2.0 to 3.0) demonstrated better cumulative survival free from the composite end point than OAT- patients (p = 0.01). In conclusion, OAT in patients with nonvalvular AF with histories of gastrointestinal ulcer made no difference in the composite end point compared to absence of OAT. In OAT+ patients, maintaining an optimal international normalized ratio reduced the composite end point, and the confirmation of ulcer healing reduced the incidence of bleeding.