Clopidogrel vs Aspirin According to Diabetes Mellitus: A Prespecified Analysis of the SMART-CHOICE 3 Trial
Primary result · MACCE in DM patientsResult — go to the resultHazard ratio 0.57 95% CI 0.38–0.86Authors' conclusion
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.
Study context
- Population
- Patients after percutaneous coronary intervention (PCI) and standard dual antiplatelet therapy (DAPT) duration with complex coronary lesions, diabetes mellitus (DM) or previous MI; DM subgroup2,089 with DM
- Participants
- 5,506 patients
- Comparison
- Clopidogrel vs aspirin monotherapy, by DM status
- Clopidogreln = 1,039
- Aspirinn = 1,050reference
- Primary endpoint
- Major adverse cardiac and cerebrovascular events (MACCE):
- Death from any cause
- MI
- Stroke
- Follow-up
- Median 2.3 years (IQR: 1.6-3.0 years)
Methodological detailsprespecified analysis, multicentre, open-label
- Prespecified analysis
- Multicentre
- Open-label
Primary result
MACCE in DM patients · median 2.3 years
Hazard ratio
0.57
95% CI 0.38–0.86
P = 0.008
By group
Clopidogrelvs Aspirin
HR 0.57 (95% CI 0.38–0.86); P = 0.008
As reported in the abstract
Further findings
| Outcome | DM | Non-DM | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| MACCE, DMvs non-DM | 6.8% | 4.7% | 1.44 (1.10–1.87) | P = 0.008 | |
| 0.512Hazard ratio (log scale) |
Safety
| Outcome | Clopidogrel | Aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Bleeding in DM patients | 2.9% | 2.9% | 1.06 (0.57–1.95) | P = 0.855 | |
| 0.512Hazard ratio (log scale) |
Original publication
Clopidogrel vs Aspirin According to Diabetes Mellitus: A Prespecified Analysis of the SMART-CHOICE 3 Trial. JACC Cardiovasc Interv. Published 16 July 2026. doi:10.
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