In patients with acute coronary syndrome at high bleeding and ischemic risk, clopidogrel monotherapy after 9 to 12 months of DAPT reduced bleeding risk.

In East-Asian patients with acute coronary syndrome (ACS) who have a high risk for bleeding and ischemic events, and who completed 9 to 12 months of dual antiplatelet therapy (DAPT) after the implantation of a drug-eluting stent, a prolonged clopidogrel monotherapy treatment outperformed a continued DAPT regimen in terms of bleeding and major adverse cardiac and cerebrovascular events. The OPT-BIRISK trial adds data to the complex issue of antithrombotic therapy after ACS in the understudied East-Asian population.

“It remains a challenge to select the optimal anti-thrombotic therapy for patients with ACS who are at high risk for bleeding and ischemic events,” said Yaling Ha, MD, at ESC Congress 2023. “Continued P2Y12 inhibitor monotherapy after 9 to 12 months of DAPT may be a sound strategy for so-called bi-risk patients with ACS.” To test this regimen, patients with ACS and high risk for bleeding and ischemic events were treated with DAPT for 9 to 12 months after drug-eluting stent implantation and then randomly assigned to clopidogrel monotherapy or continued DAPT with clopidogrel plus aspirin for 9 months. The primary endpoint of the phase 4 OPT-BIRISK trial was the risk for BARC type 2, 3, or 5 bleeding.

The results demonstrated that BARC type 2, 3, or 5 bleeding events occurred more frequently in the DAPT arm than in the clopidogrel-monotherapy arm (3.3% vs 2.5%; HR, 0.75; 95% CI, 0.57–0.97; P=0.03). This outcome was consistent across subgroups except in participants with anemia, for whom the continued DAPT strategy appeared to lead to a reduced risk for bleeding events compared with the monotherapy arm (HR, 2.17; P_interaction=0.04). Finally, major adverse cardiac and cerebrovascular events occurred more often in participants in the DAPT group (3.5% vs 2.6%; HR, 0.74; 95% CI, 0.57–0.96; P=0.02).

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