Coronary disease & ACSRandomised controlled trial
Clopidogrel Versus Aspirin Monotherapy Beyond 1 Year After PCI: The Final 5-Year Results of the STOPDAPT-2 ACS and STOPDAPT-2 Total Cohort
- multicenter, open-label, adjudicator-blinded, randomized clinical trials
- 1-year landmark analysis
- pooled cohort of the 2 trials (STOPDAPT-2 total cohort)
- 5-year follow-up
Authors' conclusion
Clopidogrel monotherapy was superior to aspirin monotherapy for cardiovascular outcomes beyond 1 year after percutaneous coronary intervention, without increased bleeding risk.
Study context
- Population
- Patients in Japan after percutaneous coronary intervention with cobalt-chromium everolimus-eluting stents; STOPDAPT-2 ACS enrolled patients with acute coronary syndrome exclusivelySTOPDAPT-2 ACS 5-year analysis, 2875 (96.3%) completed follow-up · STOPDAPT-2 ACS 2,986 · STOPDAPT-2 total cohort 5,991
- Participants
- 2,986 patients
- Comparison
- clopidogrel vs aspirin monotherapy by the 1-year landmark analysis
- clopidogrel groupn = 1,492
- aspirin groupn = 1,494reference
- Primary endpoint
- Composite of:
- Cardiovascular end point (cardiovascular death, myocardial infarction, stroke, or definite stent thrombosis)
- Bleeding end point (Thrombolysis in Myocardial Infarction major/minor)
- Follow-up
- 1-year landmark analysis, 5-year follow-up
Primary result
As reported in the abstract
clopidogrel group vs aspirin groupHazard ratio (95% CI)P value
STOPDAPT-2 ACS
0.75(0.57–0.997)
P = 0.048STOPDAPT-2 total cohort; insignificant
0.86(0.72–1.03)
P = 0.11Secondary outcomes
| Outcome | clopidogrel group | aspirin group | hazard ratio (95% CI) | P value | |
|---|---|---|---|---|---|
| Major secondary cardiovascular end point · 1-year landmark analysis · STOPDAPT-2 ACS | 4.73% | 6.77% | 0.70 (0.51–0.96) | P = 0.03 | |
| Major secondary cardiovascular end point · 1-year landmark analysis · STOPDAPT-2 total cohort | 0.74 (0.60–0.91) | P = 0.004 | |||
| 0.512Hazard ratio (log scale) |
Safety
Major secondary bleeding end point
- No between-groups difference, both in the STOPDAPT-2 ACS and STOPDAPT-2 total cohort
Original publication
Clopidogrel Versus Aspirin Monotherapy Beyond 1 Year After PCI: The Final 5-Year Results of the STOPDAPT-2 ACS and STOPDAPT-2 Total Cohort. Circ Cardiovasc Interv. Published 18 March 2026. doi:10.1161/circinterventions.125.016280
Summarised from the published abstract; every number is checked against it