Key result
Clopidogrel monotherapy cuts MACCE ~43% vs aspirin in patients with diabetes completing post-PCI DAPT.
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Why the study?
Clopidogrel monotherapy has shown superior efficacy compared to aspirin after completion of DAPT post-PCI, but limited evidence exists in patients with diabetes mellitus.
Does clopidogrel monotherapy reduce MACCE compared to aspirin monotherapy in patients with diabetes mellitus who have completed standard DAPT after PCI?
RCT (n=5,506)
Open-label
randomized
Yes
Does clopidogrel monotherapy reduce MACCE compared to aspirin monotherapy in patients with diabetes mellitus who have completed standard DAPT after PCI?
Clopidogrel monotherapy is superior to aspirin monotherapy in reducing major adverse cardiac and cerebrovascular events without increasing bleeding in patients with diabetes mellitus who have completed standard DAPT after PCI.
BACKGROUND: Recent trials support the superior efficacy of clopidogrel compared to aspirin monotherapy after completion of dual antiplatelet therapy (DAPT) in patients who have undergone percutaneous coronary intervention (PCI). However, limited evidence is available in patients with diabetes mellitus (DM). OBJECTIVES: The current study sought to evaluate the comparative efficacy and safety of clopidogrel vs aspirin monotherapy according to the presence of DM. METHODS: This was a prespecified analysis of the SMART-CHOICE 3 trial, which was a multicenter, open-label, randomized controlled trial comparing clopidogrel vs aspirin monotherapy in patients with complex coronary lesions or high-risk clinical characteristics. From August 2020 to July 2023, a total of 5,506 patients who underwent PCI and standard DAPT duration and had complex coronary lesions, DM, or previous myocardial infarction, were randomized to clopidogrel or aspirin monotherapy groups. The primary endpoint was major adverse cardiac and cerebrovascular events (MACCE), which was defined as a composite of death from any cause, myocardial infarction, or stroke. RESULTS: Of 5,506 patients, 2,089 had DM (1,039 in the clopidogrel group and 1,050 in the aspirin group). At a median follow-up of 2.3 years (IQR: 1.6-3.0 years), DM patients had a higher risk of MACCE compared to non-DM patients (6.8% vs 4.7%; HR: 1.44, 95% CI: 1.10-1.87, P = 0.008). Clopidogrel showed a significantly lower risk of MACCE than aspirin in DM patients (4.5% vs 9.1%; HR: 0.57, 95% CI: 0.38-0.86, P = 0.008). There was no significant interaction between DM and antiplatelet monotherapy regarding MACCE (P for interaction = 0.124). The risk of bleeding was comparable between the 2 groups in DM patients (2.9% vs 2.9%; HR: 1.06, 95% CI: 0.57-1.95, P = 0.855). CONCLUSIONS: Among DM patients who completed the standard duration of DAPT after PCI, clopidogrel monotherapy was associated with a lower risk of a composite of death from any cause, myocardial infarction, and stroke compared with aspirin monotherapy, without increased rates of bleeding. There was no significant interaction between DM and antiplatelet monotherapy with respect to MACCE. (SMART-CHOICE 3 [SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3]; NCT04418479).
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Lee et al. (2026) conducted an RCT in Complex coronary lesions, diabetes mellitus, or previous myocardial infarction post-PCI (n=5,506). Clopidogrel monotherapy vs. Aspirin monotherapy was evaluated on Major adverse cardiac and cerebrovascular events (MACCE), defined as a composite of death from any cause, myocardial infarction, or stroke (HR 0.57, 95% CI 0.38-0.86, p=0.008). Clopidogrel monotherapy significantly reduced the risk of MACCE compared to aspirin among patients with diabetes mellitus completing standard DAPT after PCI (4.5% vs 9.1%; HR 0.57, 95% CI 0.38-0.86).
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