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

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.