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Coronary disease & ACSRandomised controlled trial

Clopidogrel or Dual Antiplatelet Therapy in High-Ischemic-Risk Patients

N Engl J MedPublished

  • Randomised controlled trial
  • open-label
  • non-inferiority
  • South Korea
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Authors' conclusion

Among patients at high risk for ischemic events 12 months after drug-eluting stent implantation, clopidogrel monotherapy was noninferior to extended DAPT with respect to net adverse clinical events at 24 months.

Study context

Population
Patients with high-risk clinical or lesion characteristics 12 months after drug-eluting stent implantation
Participants
3,203 patients
Comparison
Clopidogrel monotherapy vs extended dual antiplatelet therapy (DAPT) beyond 12 months after DES
  • Monotherapyn = 1,601
  • DAPTn = 1,602reference
Primary endpoint
Net adverse clinical events: death from any cause, MI, stent thrombosis, stroke or Bleeding Academic Research Consortium (BARC) type 2, 3 or 5 bleeding
Follow-up
24 months

Primary result

As reported in the abstract

Risk difference

−0.1 percentage points

90% CI −1.3 to 1.2

P = 0.001 for non-inferiority

Events by treatment group

Monotherapy vs DAPT
risk difference −0.1 percentage points (90% CI −1.3 to 1.2); P for non-inferiority = 0.001

Further findings

OutcomeMonotherapyDAPTHR (95% CI)P value
Key secondary ischemic end point: death from any cause, MI, stent thrombosis or stroke · prespecified hierarchical order3.7%1.6%2.33 (1.47–3.69)P < 0.001

Safety

OutcomeMonotherapyDAPTHR (95% CI)P value
Key secondary bleeding end point: BARC type 2, 3 or 5 bleeding · prespecified hierarchical order1.8%4.1%0.43 (0.27–0.67)P < 0.001

Serious adverse events

Similar in the two groups

Original publication

Clopidogrel or Dual Antiplatelet Therapy in High-Ischemic-Risk Patients. N Engl J Med. Published 29 August 2026. doi:10.1056/nejmoa2608533
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Summarised from the published abstract; every number is checked against it