However, “In this study, the incidence of major bleeding after OAT (oral anticoagulation therapy) and antiplatelet therapy was significantly lower with confirmation of ulcer healing than without,” the authors point out.
Dr. Boyoung Joung and colleagues at Yonsei University College of Medicine in Seoul, explain that the risk-benefit profile of oral anticoagulation therapy in AF patients with a history of ulcers is poorly understood because such patients are usually excluded from clinical studies.
To investigate further, the team identified 430 patients with nonvalvular AF and GI ulcer disease. In that group, 200 were receiving OAT and 230 were not.
During a mean follow-up of 3.3 years, 14% versus 29% (p=0.001) of the two groups, respectively, had a major adverse cardiac event (MACE) that included ischemic stroke, MI, pulmonary thromboembolism, or other systemic embolism.. On the other hand, corresponding rates of major bleeding were 23% versus 11% (p=0.001), the investigators found.
When these two outcomes were combined in a composite endpoint, there was no statistically significant difference between the two groups at 29% versus 36% (p=0.08), according to the report.
As mentioned, though, major bleeding among patients receiving anticoagulation was less likely in those with a healed ulcer (14%) than those with a non-healed ulcer (30%; p=0.02).
Furthermore, occurrence of the composite endpoint was less likely in anticoagulated patients who stayed in the therapeutic INR range for 60% or more of the time than in patients not on anticoagulation (adjusted relative risk 0.45; p=0.01), Dr. Joung and colleagues report.
Summing up, they conclude, “Our study suggests that after confirmation of ulcer healing, OAT with an optimal INR is beneficial for patients with nonvalvular AF with histories of GI ulcer.”