Randomised controlled trial
Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial
- Randomised controlled trial
- open-label
- multicentre
- 26 sites in South Korea
Authors' conclusion
Among patients who were at high risk of recurrent ischaemic events and who completed the standard duration of DAPT following PCI, clopidogrel monotherapy, compared with aspirin monotherapy, significantly reduced the cumulative incidence of a composite of death from any cause, myocardial infarction, and stroke, without an apparent increase in the risk of bleeding.
Study context
- Population
- Patients ≥19 years at high risk of recurrent ischaemic events (prior MI, medication-treated DM or complex coronary lesions) who completed standard-duration DAPT after percutaneous coronary intervention (PCI) with drug-eluting stentsmedian follow-up 2.3 years
- Participants
- 5,506 patients
- Comparison
- Clopidogrel vs aspirin monotherapy after standard-duration DAPT
- Clopidogreln = 2,752
- Aspirinn = 2,754reference
- Primary endpoint
- Composite of:
- All-cause death
- MI
- Stroke (ITT population)
- Follow-up
- 3 years (Kaplan-Meier)
Primary result
All-cause death, MI or stroke · 3 years
Hazard ratio
0.71
95% CI 0.54–0.93
P = 0.013
Events by treatment group
Clopidogrel vs Aspirin
HR 0.71 (95% CI 0.54–0.93); P = 0.013
As reported in the abstract
Secondary outcomes
| Outcome | Clopidogrel | Aspirin | HR (CI) | |
|---|---|---|---|---|
| All-cause death · 3 years | 2.4% (CI 1.6–3.1) | 4.0% (CI 2.9–5.0) | 0.71 (0.49–1.02) | |
| MI · 3 years | 1.0% (CI 0.6–1.4) | 2.2% (CI 1.4–2.9) | 0.54 (0.33–0.90) | |
| Stroke · 3 years | 1.3% (CI 0.7–2.0) | 1.3% (CI 0.8–1.7) | 0.79 (0.46–1.36) | |
| 0.20.5125Hazard ratio (log scale) |
Safety
| Outcome | Clopidogrel | Aspirin | HR (CI) | |
|---|---|---|---|---|
| Bleeding · 3 years | 3.0% (CI 2.0–3.9) | 3.0% (CI 2.2–3.9) | 0.97 (0.67–1.42) | |
| 0.512Hazard ratio (log scale) |
Bleeding · 3 years
- No difference in bleeding risk
Any adverse event
- Clopidogrel not associated with higher incidence of any adverse event vs aspirin
Original publication
Efficacy and safety of clopidogrel versus aspirin monotherapy in patients at high risk of subsequent cardiovascular event after percutaneous coronary intervention (SMART-CHOICE 3): a randomised, open-label, multicentre trial. Lancet. Published 30 March 2025. doi:10.1016/s0140-6736(25)00449-0
Summarised from the published abstract; every number is checked against it