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

Area of Science:

• Cardiology
• Gastroenterology
• Pharmacology

Background:

• Bleeding is a primary concern for patients on oral anticoagulation therapy (OAT), particularly those with a history of gastrointestinal ulcers.
• Nonvalvular atrial fibrillation (AF) patients with ulcer histories require careful management balancing anticoagulation benefits against bleeding risks.

Purpose of the Study:

• To evaluate the efficacy and safety of OAT in nonvalvular AF patients with a history of gastrointestinal ulcers.
• To compare composite endpoints of major adverse cardiac events or major bleeding between OAT users and non-users in this patient cohort.

Main Methods:

• A cohort study comparing patients with AF and previous ulcers who were on OAT (OAT+) versus those not on OAT (OAT-).
• Follow-up period of 3.3 ± 2.7 years, assessing major adverse cardiac events and major bleeding.
• Subgroup analysis for OAT+ patients based on ulcer healing status and international normalized ratio (INR) control.

Main Results:

• No significant difference in the composite endpoint (major adverse cardiac events or major bleeding) between OAT+ (29%) and OAT- (36%) patients (p = 0.08).
• Major bleeding incidence was significantly lower (14%) when OAT commenced after endoscopic confirmation of ulcer healing, compared to 30% before healing (p = 0.02).
• OAT+ patients achieving an international normalized ratio (INR) time in therapeutic range (TTR) ≥60% showed better survival free from the composite endpoint (p = 0.01).

Conclusions:

• OAT in nonvalvular AF patients with a history of gastrointestinal ulcers did not significantly alter the composite endpoint compared to no OAT.
• Initiating OAT after endoscopic ulcer healing significantly reduces bleeding risk.
• Optimal INR control (TTR ≥60%) in OAT+ patients improves outcomes, reducing the composite endpoint.