Key result
Indobufen shows similar NACE to aspirin in elderly post-PCI ACS patients, with fewer GI symptoms.
Why the study?
Aspirin use after PCI in elderly ACS patients is sometimes limited by gastrointestinal complications or allergic reactions, requiring evaluation of indobufen as an alternative.
Does indobufen in combination with clopidogrel reduce Net Adverse Clinical Events in elderly ACS patients post-PCI compared to aspirin in combination with clopidogrel?
Cohort (n=2,087)
No
Does indobufen in combination with clopidogrel reduce Net Adverse Clinical Events in elderly ACS patients post-PCI compared to aspirin in combination with clopidogrel?
Effect estimate: HR 1.029 (95% CI 0.714-1.484)
Absolute Event Rate: 19.9% vs 18.6%
p-value: p=0.876
Indobufen combined with clopidogrel demonstrates comparable efficacy and safety to aspirin with clopidogrel in elderly ACS patients post-PCI, while potentially reducing gastrointestinal symptoms.
Suggests indobufen may be a tolerable aspirin alternative for elderly post-PCI patients with gastrointestinal.
BACKGROUND: Antiplatelet therapy is pivotal in managing elderly patients with Acute Coronary Syndrome (ACS) following Percutaneous Coronary Intervention (PCI). While aspirin remains a cornerstone of this therapy, its use is sometimes limited by the risk of gastrointestinal (GI) complications or allergic reactions in certain patients. PURPOSE: This study aims to assess the safety and efficacy of Indobufen as an alternative to aspirin when used in combination with clopidogrel in elderly ACS patients post-PCI. METHODS: This is a single-center, retrospective study employing propensity score matching. Elderly ACS patients who underwent PCI between January 2019 and May 2022 were enrolled. Participant were categorized into two groups based on their medication regimen: the aspirin DAPT group and the indobufen DAPT group. The primary endpoint was the Net Adverse Clinical Event (NACE) at 1 year, which included all-cause mortality, stroke, myocardial infarction (MI), target lesion revascularisation, and bleeding events classified under the Bleeding Academic Research Consortium (BARC) criteria type 2, 3, or 5. RESULTS: A total of 2087 patients were enrolled in this study. Based on their medication regimen, 348 patients were assigned to indobufen DAPT group, while 1739 individuals were assigned to aspirin DAPT group. After applying 1:1 propensity score matching, 306 patients were included in each group. During the 1-year follow-up, the NACE occurred in 59 patients (19.9%) of the Indobufen DAPT group and 58 patients (18.6%) in the aspirin DAPT group, with no significant difference between the groups (HR 1.029, 95% CI 0.714-1.484, P = 0.876). Additionally, there were no significant difference in Patient-Oriented Composite Endpoint (POCE) and BARC 2, 3, or 5 bleeding events between the groups at 1, 3, or 6 months of follow-up. However, the indobufen DAPT group experienced a lower incidence of upper GI symptoms compared to the aspirin DAPT group. CONCLUSION: Indobufen, as an alternative to aspirin, demonstrates comparable efficacy and safety in elderly ACS patients after PCI, with a potential reduction in gastrointestinal symptoms. These findings support the use of indobufen as a viable alternative for elderly ACS patients who are intolerant to aspirin. CLINICAL TRIAL NUMBER: Not applicable.
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Dai et al. (2025) conducted a cohort in Acute Coronary Syndrome (ACS) post-PCI (n=2,087). Indobufen plus clopidogrel vs. Aspirin 100 mg daily plus clopidogrel 75 mg daily was evaluated on Net Adverse Clinical Event (NACE) at 1 year (HR 1.029, 95% CI 0.714-1.484, p=0.876). Indobufen demonstrated comparable efficacy and safety to aspirin in elderly patients with acute coronary syndrome post-percutaneous coronary intervention, with no significant difference in 1-year Net Adverse Clinical Events (HR 1.029) but a lower incidence of upper gastrointestinal symptoms.
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