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

Abstract

Bleeding is the major concern for patients on oral anticoagulation therapy (OAT), especially in patients with a history of gastrointestinal (GI) ulcer. We evaluated the efficacy and safety of OAT in nonvalvular atrial fibrillation (AF) patients with ulcer history. We compared a composite endpoint, including major adverse cardiac events (MACE) or major bleeding, between AF patients with previous ulcer who were (OAT+, n = 200) and were not (OAT-, n = 230) taking OAT. During the follow-up period of 3.3 ± 2.7 years, 28 (14%) and 66 (29%) patients in OAT+ and OAT-, respectively, had MACE (P = 0.001). Major bleeding occurred in 46 (23%) OAT+ patients and 25 (11%) OAT- patients (P = 0.001). There was no significant difference in the composite endpoint between OAT+ and OAT- (29% vs. 36%, P = 0.08). The incidence of major bleeding was significantly lower, decreasing from 30% to 14%, when OAT started after endoscopic confirmation of ulcer healing (P = 0.02). OAT+ patients who achieved time in therapeutic range (TTR) ≥ 60% of international normalized ratio (INR) 2.0~3.0 demonstrated better cumulative survival free from composite endpoint than OAT- patients (P = 0.01). In conclusion, OAT in nonvalvular AF patients with GI ulcer history made no difference in the composite endpoint compared to the non OAT. In patients on OAT, maintaining an optimal INR level reduced the composite endpoint, and the confirmation of ulcer healing reduced the incidence of bleeding.