Indobufen versus aspirin for platelet inhibition: efficacy and safety insights from the INSURE and OPTION trials.

This study systematically compares the antiplatelet efficacy and safety of indobufen and aspirin based on two key clinical trials, INSURE and OPTION. The INSURE trial showed that in patients with acute moderate-to-severe ischemic stroke, indobufen was significantly less effective than aspirin in preventing stroke recurrence and did not exhibit superior bleeding safety. In contrast, the OPTION trial indicated that in post-percutaneous coronary intervention patients, indobufen combined with clopidogrel was non-inferior to aspirin combined with clopidogrel in preventing ischemic events and yielded superior net clinical benefit, primarily attributable to a significant reduction in bleeding risk. Analysis of their pharmacological mechanisms suggests these differences may correlate with varying degrees of platelet activation and thrombotic mechanisms under distinct clinical conditions. Subgroup analyses further reveal that comorbidities including diabetes, hypertension, and varying stroke severity may affect therapeutic outcomes, underscoring the value of individualized treatment strategies. In summary, the clinical positioning of indobufen should be tailored to the treatment context and patient characteristics: it is not recommended as a routine alternative to aspirin for secondary prevention of acute ischemic stroke, but it may serve as a potential therapeutic option in coronary artery disease patients at high bleeding risk or intolerant to aspirin supported by limited clinical evidence, rather than a broadly established alternative. Caution is warranted given the absence of supporting evidence from international guidelines and limited regulatory approval in many regions. Future research should further clarify its benefit-risk profile across diverse populations and combination regimens to guide precision therapy.