OPT-BIRISK
Trial question
Is extended clopidogrel monotherapy superior to dual antiplatelet therapy in patients with acute coronary syndrome at high ischemic and bleeding risk after PCI?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
41.0% female
59.0% male
N = 7758
7758 patients (3183 female, 4575 male).
Inclusion criteria: patients with acute coronary syndrome at high ischemic and bleeding risk after PCI.
Key exclusion criteria: surgery plan within 90 days; coronary revascularization program within 90 days; dialysis-dependent renal failure; moderate or severe hepatic insufficiency; life expectancy < 1 year.
Interventions
N=3873 clopidogrel monotherapy (extended antiplatelet with clopidogrel plus placebo for 9 months).
N=3885 clopidogrel plus aspirin (extended dual antiplatelet therapy with clopidogrel plus aspirin for 9 months).
Primary outcome
Bleeding Academic Research Consortium types 2, 3, or 5 bleeding at 9 months
2.5%
3.3%
3.3 %
2.5 %
1.6 %
0.8 %
0.0 %
Clopidogrel
monotherapy
Clopidogrel plus
aspirin
Significant
decrease ▼
NNT = 125
Significant decrease in Bleeding Academic Research Consortium types 2, 3, or 5 bleeding at 9 months (2.5% vs. 3.3%; HR 0.75, 95% CI 0.57 to 0.97).
Secondary outcomes
Significant decrease in major adverse cardiac and cerebral events (2.6% vs. 3.5%; HR 0.74, 95% CI 0.57 to 0.96).
No significant difference in death from any cause (0.3% vs. 0.5%; HR 0.72, 95% CI 0.35 to 1.48).
No significant difference in MI (0.4% vs. 0.7%; HR 0.59, 95% CI 0.32 to 1.1).
Safety outcomes
Significant difference in net adverse clinical events (4.9% vs. 6.6%).
Conclusion
In patients with acute coronary syndrome at high ischemic and bleeding risk after PCI, clopidogrel monotherapy was superior to clopidogrel plus aspirin with respect to Bleeding Academic Research Consortium types 2, 3, or 5 bleeding at 9 months.
Reference
Yi Li, Jing Li, Bin Wang et al. Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk: The OPT-BIRISK Randomized Clinical Trial. JAMA Cardiol. 2024 Jun 1;9(6):523-531.
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