Key result
Extended clopidogrel monotherapy reduced BARC 2, 3, or 5 bleeding without HF (HR 0.70, 95% CI 0.53-0.92) vs with HF (HR 1.49, 95% CI 0.63-3.53; Pint=0.1021).
Why the study?
Does extended clopidogrel monotherapy for 9 months reduce BARC types 2, 3, or 5 bleeding compared to dual antiplatelet therapy in acute coronary syndrome patients with and without heart failure after PCI?
RCT (n=7,758)
Placebo-controlled
Randomized to clopidogrel plus placebo or aspirin (prespecified subgroup analysis by recorded HF history)
Does extended clopidogrel monotherapy for 9 months reduce BARC types 2, 3, or 5 bleeding compared to dual antiplatelet therapy in acute coronary syndrome patients with and without heart failure after PCI?
Extended clopidogrel monotherapy after 9-12 months of DAPT post-PCI for ACS reduced clinically relevant bleeding and MACCE in patients without HF, with no significant interaction by HF status though HF subgroup results were inconclusive due to low event rates.
Answers are grounded in this paper and cite their sources.
Subgroup findings are hypothesis-generating and should not yet change extended antiplatelet selection in post-PCI ACS with HF; leaves open whether HF modifies clopidogrel monotherapy benefit.
BACKGROUND: The optimal extended antiplatelet strategy after percutaneous coronary intervention (PCI) for acute coronary syndrome (ACS) in patients with heart failure (HF) remains uncertain. METHODS: In OPT-BIRISK, patients at high ischemic and bleeding risk who completed 9-12 months of dual antiplatelet therapy (DAPT) were randomized to clopidogrel plus placebo or aspirin for 9 months. This analysis compared treatments by recorded HF history. The primary endpoint was Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding; the key secondary endpoint was major adverse cardiac and cerebral events (MACCE). RESULTS: Of 7,758 patients, 653 (8.4%) had HF history. Without HF, bleeding occurred in 83/3,565 (2.3%) monotherapy recipients and 118/3,540 (3.3%) DAPT recipients (HR 0.70, 95% CI 0.53-0.92). With HF, bleeding occurred in 12/308 (3.9%) and 9/345 (2.6%), respectively (HR 1.49, 95% CI 0.63-3.53). MACCE occurred in 90/3,565 (2.5%) versus 120/3,540 (3.4%) patients without HF (HR 0.74, 95% CI 0.57-0.98) and 11/308 (3.6%) versus 16/345 (4.6%) patients with HF (HR 0.77, 95% CI 0.36-1.66). Interaction P values were 0.1021 for bleeding and 0.9345 for MACCE. CONCLUSIONS: Extended clopidogrel monotherapy reduced clinically relevant bleeding in patients without a history of HF after PCI for ACS. No statistically significant treatment-by-HF interaction was observed for bleeding or MACCE, although HF-specific treatment effects remain inconclusive because of limited events.
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Jiang et al. (2026) conducted an RCT in Acute coronary syndrome after percutaneous coronary intervention with or without heart failure (n=7,758). Extended clopidogrel monotherapy (clopidogrel plus placebo) vs. Extended dual antiplatelet therapy (clopidogrel plus aspirin) was evaluated on Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding (HR 1.49, 95% CI 0.63-3.53, p=0.1021 for interaction). Extended clopidogrel monotherapy reduced BARC 2, 3, or 5 bleeding without HF (HR 0.70, 95% CI 0.53-0.92) vs with HF (HR 1.49, 95% CI 0.63-3.53; Pint=0.1021).
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