A Novel Approach to Gastrointestinal Bleeding Risk Stratification and Proton Pump Inhibitor Effectiveness in Patients with Acute Coronary Syndrome on Dual Antiplatelet Therapy: A Nationwide Retrospective Cohort Study.

PURPOSE

Proton pump inhibitors (PPIs) are effective in preventing gastrointestinal (GI) bleeding in high-risk patients on dual antiplatelet therapy (DAPT). Existing criteria for high GI bleeding risk, such as those from the American Heart Association (AHA), may not fully reflect East Asian patient profiles. This study aimed to evaluate the effectiveness of PPIs in preventing GI bleeding across DAPT combinations, stratified by GI bleeding risk using the Academic Research Consortium High Bleeding Risk (ARC-HBR) criteria in patients with acute coronary syndrome (ACS).

METHODS

A retrospective cohort of 93,153 patients with ACS initiating DAPT (2018-2020) was analyzed using the Korean National Health Insurance database. Modified ARC-HBR (mARC-HBR) criteria tailored to claims data were compared with AHA criteria in terms of concordance and performance. PPI effects on GI bleeding were analyzed by mARC-HBR risk groups over a 3-year observation period.

RESULTS

The mARC-HBR criteria identified three times more high-risk patients than the AHA criteria, demonstrating higher sensitivity (38.9% vs. 11.1%, p < 0.001) while maintaining a relatively high specificity (both > 70%). While PPI use offered no benefit for low-risk patients, it was associated with a 25.8% lower GI bleeding risk in high-risk patients, with the most pronounced effect observed in those on the aspirin/ticagrelor combination.

CONCLUSION

The mARC-HBR criteria enhance the identification of high GI bleeding risk patients with ACS and may inform targeted PPI use, given the observed associations suggesting potential benefit in high-risk ticagrelor users and limited effect in low-risk groups.