What question did this study set out to answer?

This research aims to evaluate the efficacy and safety of indobufen-based dual antiplatelet therapy in ACS patients with a history of gastrointestinal damage.

February 25, 2026Open Access

The Efficacy and Safety of Indobufen-Based DAPT in ACS Patients with a History of Gastrointestinal Damage Undergoing PCI: A Single-Center, Observational Study

Q: What does this research mean for the field?

Indobufen-based dual antiplatelet therapy reduces major adverse gastrointestinal events by 42% compared to aspirin in acute coronary syndrome patients with a history of gastrointestinal damage undergoing percutaneous coronary intervention, without increasing major adverse cardiovascular events. Novelty: ClaimNovelty.INCREMENTAL. Consensus alignment: ConsensusAlignment.NEUTRAL.

Key Result

Indobufen-based DAPT reduced major adverse GI events by 42% (25.6% vs 39.4%, HR=0.58) compared to aspirin in ACS patients with GI damage post-PCI.

Key Points

This research aims to evaluate the efficacy and safety of indobufen-based dual antiplatelet therapy in ACS patients with a history of gastrointestinal damage.
Retrospective analysis of 255 PCI patients with gastrointestinal damage
Comparison of indobufen (n = 90) and aspirin (n = 165) groups
Used composite endpoints for major and significant gastrointestinal events
Indobufen reduced major adverse gastrointestinal events (25.6% vs 39.4%, P = 0.026)
Indobufen decreased clinically significant adverse gastrointestinal events (18.9% vs 33.3%, P = 0.020)
No significant difference in major adverse cardiovascular events (4.4% vs 6.7%, P = 0.400)

Structured PICO

Does indobufen-based DAPT reduce adverse gastrointestinal events compared to aspirin-based DAPT in ACS patients with a history of gastrointestinal damage undergoing PCI?

Population

255 acute coronary syndrome (ACS) patients with a history of gastrointestinal damage undergoing percutaneous coronary intervention (PCI)

Intervention

Indobufen-based dual antiplatelet therapy (DAPT)

Comparator

Aspirin-based dual antiplatelet therapy (DAPT)

Outcome

Composite of major adverse gastrointestinal events (dyspepsia, peptic ulcer disease and gastrointestinal hemorrhage)composite

In ACS patients with prior gastrointestinal damage undergoing PCI, indobufen-based DAPT significantly reduces adverse gastrointestinal events compared to aspirin-based DAPT without increasing the risk of major adverse cardiovascular events.

Main Result

Absolute Event Rate: 0% vs 0%

Abstract

Purpose Indobufen, an alternative to aspirin in acute coronary syndrome (ACS) patients with gastrointestinal damage undergoing percutaneous coronary intervention (PCI), has limited data on its efficacy and safety in long-term use. This study compared indobufen-based dual antiplatelet therapy (DAPT) to aspirin-based DAPT in such patients. Methods We retrospectively analyzed 255 PCI patients with a history of gastrointestinal damage, divided into indobufen (n = 90) and aspirin (n = 165) groups. We defined the composite of major adverse gastrointestinal events as a composite endpoint event of dyspepsia, peptic ulcer disease and gastrointestinal hemorrhage. Concurrently, the composite of clinically significant adverse gastrointestinal events has been designated as a composite endpoint comprising peptic ulcer disease and gastrointestinal hemorrhage. Results Indobufen significantly reduced the incidence of the composite of major adverse gastrointestinal events (25.6% vs 39.4%, HR = 0.58, 95% CI:0.36–0.94, P = 0.026) and the composite of clinically significant adverse gastrointestinal events (18.9% vs 33.3%, HR = 0.53, 95% CI:0.30–0.90, P = 0.020) compared to aspirin. There was no significant difference in major adverse cardiovascular events (MACE) incidence between the two groups (4.4% vs 6.7%, P = 0.400). Conclusion In conclusion, compared with aspirin, the use of indobufen-based DAPT was associated with a lower incidence of the composite of major adverse gastrointestinal events, which was mainly driven by a reduction in the clinical symptoms and an improvement in quality of life.