Coronary disease & ACSRandomised controlled trial
Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention
- Randomised controlled trial
- multicentre
- open-label
- adjudicator-blinded
- non-inferiority
Authors' conclusion
Clopidogrel might be an attractive alternative to aspirin with a borderline ischemic benefit beyond 1 year after PCI.
Study context
- Population
- Patients who underwent percutaneous coronary intervention (PCI) with cobalt-chromium everolimus-eluting stents, Japan2,934 completed 5-year follow-up
- Participants
- 3,005 patients
- Comparison
- Clopidogrel vs Aspirin
- Primary endpoint
- Composite of:
- CV outcomes (CV death, MI, stroke or definite stent thrombosis)
- Major bleeding (TIMI major or minor)
- Follow-up
- 5 years
Primary result
As reported in the abstract
Hazard ratio
0.85
95% CI 0.70–1.05
P = 0.13 for superiority
By group
Clopidogrel vs Aspirin
HR 0.85 (95% CI 0.70–1.05); P for superiority = 0.13
Further findings
| Outcome | Clopidogrel | Aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| CV outcomes · 5 years | 8.61% | 11.05% | 0.77 (0.61–0.97) | P = 0.03 | |
| CV events, 1-year landmark analysis · beyond 1 year | 6.79% | 8.68% | 0.77 (0.59–1.01) | P = 0.06 | |
| 0.512Hazard ratio (log scale) |
Safety
| Outcome | Clopidogrel | Aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| Major bleeding (TIMI major or minor) · 5 years | 4.44% | 4.92% | 0.89 (0.64–1.25) | P = 0.51 | |
| Major bleeding, 1-year landmark analysis · beyond 1 year | 3.99% | 3.32% | 1.23 (0.84–1.81) | P = 0.31 | |
| 0.512Hazard ratio (log scale) |
Original publication
Clopidogrel vs Aspirin Monotherapy Beyond 1 Year After Percutaneous Coronary Intervention. J Am Coll Cardiol. Published 23 October 2023. doi:10.1016/j.jacc.2023.10.013
Summarised from the published abstract; every number is checked against it