# APBA Kısa Özet

Extended clopidogrel monotherapy after 9-12 months of dual-antiplatelet therapy significantly reduced bleeding without increasing ischemic events in birisk ACS patients with diabetes, offering a safer long-term strategy.

# Çalışma neyi araştırdı?

This prespecified subgroup analysis of the OPT-BIRISK trial investigated whether the benefits of extended clopidogrel monotherapy observed in high bleeding and ischemic risk (birisk) patients without diabetes also extend to birisk patients with type 2 diabetes. The study aimed to determine if stopping aspirin after 9-12 months of dual-antiplatelet therapy (DAPT) is safe and effective for this specific high-risk subgroup.

# Yöntem

The OPT-BIRISK trial randomized 7,758 birisk patients with acute coronary syndrome (ACS) who had completed 9-12 months of DAPT after percutaneous coronary intervention (PCI). Patients were then randomized 1:1 to receive 9 months of clopidogrel plus placebo versus clopidogrel plus aspirin. The prespecified subgroup analysis evaluated outcomes based on diabetes status. The primary endpoint was Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 9 months. Secondary endpoints included major adverse cardiac and cerebral events (MACCE). The analysis assessed interactions between treatment assignment and diabetes status.

# Temel bulgular

Of 7,758 patients, 4,072 (52.5%) had diabetes. In the diabetic subgroup, clopidogrel monotherapy reduced bleeding events (2.1% vs 3.2%; HR 0.66, 95% CI 0.45-0.97) without a significant increase in MACCE (2.9% vs 3.6%; HR 0.79, 95% CI 0.56-1.12). The hazard ratios indicated a favorable safety profile without compromising ischemic protection. Outcomes were consistent in patients without diabetes, with no significant interactions by diabetes status, suggesting the benefit applies across the birisk population.

# Bulgular ne anlama geliyor?

Extended clopidogrel monotherapy after 9-12 months of DAPT is a viable long-term maintenance strategy for birisk ACS patients, including those with diabetes. It significantly reduces the risk of clinically relevant bleeding without increasing the risk of recurrent ischemic events. The consistency of outcomes across diabetes status supports a broader application of this strategy in clinical practice, potentially improving the benefit-risk balance for patients who remain at high risk for both bleeding and thrombosis.

# Klinik önem

For clinicians managing birisk ACS patients with diabetes, this trial provides evidence that transitioning to clopidogrel monotherapy after the initial 9-12 month DAPT period can reduce bleeding complications—a major concern in diabetic patients who often have concomitant comorbidities—without sacrificing ischemic protection. This finding may influence guideline recommendations and support shared decision-making regarding long-term antiplatelet strategies.

# Sınırlılıklar

Several limitations should be considered. This was a prespecified subgroup analysis, which may have limited statistical power for interaction tests. The analysis was underpowered to detect potential differences between diabetes subgroups. Bleeding and ischemic events were evaluated in a prespecified manner; unplanned events may not be captured. Outcomes were consistent across diabetes status, but the analysis was underpowered to detect potential differences. Generalizability to non-birisk populations or different stent types is unclear. Long-term outcomes beyond the 9-month follow-up period post-randomization were not reported.