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Bleeding risk and major adverse events in patients with previous ulcer on oral anticoagulation therapy
The American Journal of Cardiology, 07/31/2012
Clinical Article
Lee SJ et al. – Oral anticoagulation therapy (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.
Methods- 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).