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

Q: What is the clinical evidence from this study?

Study design: Cohort. Population: Acute Coronary Syndrome on Dual Antiplatelet Therapy (n=93153). Intervention: Proton pump inhibitors (PPIs) vs. Gastroprotective agent (GPA) non-users. Primary outcome: Gastrointestinal bleeding in high-risk patients (HR 0.74, 95% CI 0.56-0.98, p=0.044).

Q: What does this research mean for the field?

Proton pump inhibitor use is associated with a 25.8% lower risk of gastrointestinal bleeding compared to non-use in high-risk patients with acute coronary syndrome on dual antiplatelet therapy, but offers no benefit to low-risk patients. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Mee Yeon Lee; Kyu‐Nam Heo; Jaekyu Shin; Ju‐Yeun Lee

doi:10.1007/s10557-025-07702-4

April 26, 2025Cardiovascular Drugs and TherapyOpen Access

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

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Key result

PPI use linked to ~26% lower GI bleeding risk in high-risk ACS patients on DAPT.

HR 0.74
95% CI 0.56-0.98
P=0.044
n=93,153

Figures

Why the study?

Existing criteria for high GI bleeding risk, such as AHA criteria, may not fully reflect East Asian patient profiles, warranting evaluation of PPI effectiveness stratified by ARC-HBR criteria across DAPT combinations.

Does proton pump inhibitor use reduce gastrointestinal bleeding in patients with acute coronary syndrome on dual antiplatelet therapy?

Key Points

The study aims to evaluate the effectiveness of proton pump inhibitors (PPIs) for preventing gastrointestinal bleeding in acute coronary syndrome (ACS) patients on dual antiplatelet therapy (DAPT) using modified risk criteria.
Analyzed a retrospective cohort of 93,153 ACS patients initiating DAPT from 2018-2020 using the Korean National Health Insurance database.
Compared modified ARC-HBR criteria with AHA criteria for risk stratification.
Assessed PPI effects on GI bleeding over a 3-year observation period across different risk groups.
The mARC-HBR criteria identified three times more high-risk patients compared to AHA criteria, with sensitivity at 38.9% versus 11.1% (p < 0.001).

Study Design

Type

Cohort (n=93,153)

Multicenter

Yes

Structured PICO

Does proton pump inhibitor use reduce gastrointestinal bleeding in patients with acute coronary syndrome on dual antiplatelet therapy?

P

Population

93,153 patients with acute coronary syndrome (ACS) initiating dual antiplatelet therapy (DAPT) between 2018-2020, from the Korean National Health Insurance database.

I

Intervention

Proton pump inhibitors (PPIs)

C

Comparator

No PPI use

O

Outcome

Gastrointestinal (GI) bleeding over a 3-year observation periodsafety

Main Result

Effect estimate: HR 0.74 (95% CI 0.56-0.98)

Absolute Event Rate: 1.72% vs 2.29%

p-value: p=0.044

Modified ARC-HBR criteria better identify high GI bleeding risk in East Asian ACS patients on DAPT, for whom targeted PPI therapy significantly reduces bleeding risk.

Limitations

The ARC-HBR criteria were modified due to claims data constraints, limiting interpretation to the mARC-HBR criteria.
Anticoagulant users were excluded, omitting a clinically significant population.
Retrospective design precludes causal inference and is subject to residual confounding.
Findings from Korean patients may limit generalizability to other Asian or non-Asian populations.
Reliance on claims data lacked clinical details such as medication adherence and over-the-counter medication use.
Did not distinguish between oral and injectable PPI formulations.
Focused on three DAPT combinations, limiting generalizability to other regimens.

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Answers are grounded in this paper and cite their sources.

Implication

PPI use was associated with lower GI bleeding risk in high-risk ACS on DAPT; hypothesis-generating and requires randomized confirmation.

Abstract

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.

Discussion

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Cite This Study

Lee et al. (2025) conducted a cohort in Acute Coronary Syndrome on Dual Antiplatelet Therapy (n=93,153). Proton pump inhibitors (PPIs) vs. Gastroprotective agent (GPA) non-users was evaluated on Gastrointestinal bleeding in high-risk patients (HR 0.74, 95% CI 0.56-0.98, p=0.044). Proton pump inhibitor use was associated with a 25.8% lower risk of gastrointestinal bleeding compared to non-use in high-risk patients with acute coronary syndrome on dual antiplatelet therapy.

synapsesocial.com/papers/6a11a747e00e306083b6b699 https://doi.org/10.1007/s10557-025-07702-4

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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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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

Figures

Key Points

Study Design

Structured PICO

Main Result

Limitations

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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