Extended Clopidogrel Monotherapy vs Dual Antiplatelet Therapy (DAPT) in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk: The OPT-BIRISK Randomized Clinical Trial
Authors' conclusion
Among birisk patients with ACS who completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months before randomization, an extended 9-month clopidogrel monotherapy regimen was superior to continuing DAPT with clopidogrel in reducing clinically relevant bleeding without increasing ischemic events.
Study context
- Population
- Patients with acute coronary syndromes (ACS) at high bleeding and ischemic risk (birisk) who completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months
- Participants
- 7,758 patients
- Comparison
- Extended clopidogrel monotherapy vs continued DAPT
- Clopidogrel plus placebon = 3,873
- Clopidogrel plus aspirinn = 3,885reference
- Primary endpoint
- Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding (tested for superiority)
- Follow-up
- 9 months after randomization
Methodological detailsmulticentre, double-blind, placebo-controlled, 101 China centres
- Multicentre
- Double-blind
- Placebo-controlled
- 101 China centres
Primary result
As reported in the abstract
BARC types 2, 3, or 5 bleeding · 9 months
Each group vs clopidogrel plus aspirinHazard ratio (95% CI)P value
Clopidogrel plus placebo
0.75(0.57–0.97)
P = 0.03Each group vs clopidogrel plus aspirinDifference, % (95% CI)P value
Clopidogrel plus placebo
−0.8(−1.6% to −0.1%)
P = 0.03Secondary outcomes
| Outcome | Clopidogrel plus placebo | Clopidogrel plus aspirin | HR (95% CI) | P value | |
|---|---|---|---|---|---|
| MACCE (all-cause death, MI, stroke or clinically driven revascularization), key secondary end point · P = .02 for superiority · sequential noninferiority and superiority testing | 2.6% | 3.5% | 0.74 (0.57–0.96) | P = 0.02 | |
| 0.512Hazard ratio (log scale) |
| Outcome | Difference (%) (95% CI) | P value | |
|---|---|---|---|
| MACCE (all-cause death, MI, stroke or clinically driven revascularization), key secondary end point · P < .001 for noninferiority · sequential noninferiority and superiority testing | −0.9 (−1.7% to −0.1%) | P < 0.001 | |
| −2−101Difference, % (linear scale) |
Original publication
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. Published 1 June 2024. doi:10.
Summarised from the published abstract; every number is checked against it