Trial Title: OPT-BIRISK
Study Type: Multicenter, double-blind, randomized trial
Objective:
To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing dual antiplatelet therapy (DAPT) with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in high ischemic and bleeding risk (birisk) patients with acute coronary syndromes (ACS).
Patients:
- Total Patients: 7,758
- Inclusion Criteria:
- Aged 18-85 years
- High bleeding or ischemic risk
- Underwent PCI for ACS
- Completed 9-12 months of DAPT
- Exclusion Criteria:
- Discontinuation or termination of DAPT treatment during the past 6 months due to adverse events
- Coronary revascularization or surgery planned within 90 days
- Life expectancy <1 year
Comparison Groups:
- Clopidogrel + Placebo (n = 3,873)
- Clopidogrel + Aspirin (n = 3,885)
Primary Outcomes:
- Clinically relevant bleeding at 9 months (%)
- Clopidogrel + Placebo: 2.5%
- Clopidogrel + Aspirin: 3.3%
- Hazard Ratio (HR): 0.75, 95% Confidence Interval (CI): 0.57-0.97 (P = 0.03)
- BARC 3, 5 bleeding (%)
- Clopidogrel + Placebo: 0.5%
- Clopidogrel + Aspirin: 0.7%
- (P > 0.05)
Secondary Outcomes:
- Major adverse cardiovascular and cerebrovascular events (%)
- Clopidogrel + Placebo: 2.6%
- Clopidogrel + Aspirin: 3.5%
- HR: 0.74, 95% CI: 0.57-0.96
- All-cause mortality (%)
- Clopidogrel + Placebo: 0.3%
- Clopidogrel + Aspirin: 0.5%
- (P = 0.38)
Conclusion:
Among birisk patients with ACS who completed 9 to 12 months of DAPT after drug-eluting stent implantation, an extended 9-month clopidogrel monotherapy regimen was superior to continuing DAPT with clopidogrel in reducing clinically relevant bleeding without increasing ischemic events.
Source:
Li Y et al. JAMA Cardiol 2024;Apr 17:[Epublished]
This data summarizes the key findings and details from the OPT-BIRISK trial.