DAPT or clopidogrel monotherapy after stenting in high-risk East-Asian patients?

In East-Asian patients with acute coronary syndrome (ACS) who were at high risk for bleeding and ischaemic 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 antithrombotic therapy for patients with ACS who are at high risk for bleeding and ischaemic events,” said Prof. Yaling Han (General Hospital of Northern Theater Command, China) [1]. “Continued P2Y₁₂ inhibitor monotherapy after 9–12 months of DAPT may be a sound strategy for so-called bi-risk patients with ACS.” To test this regimen, patients with ACS with high bleeding and ischaemic risk were treated with DAPT for 9–12 months after drug-eluting stent implantation and then randomised to clopidogrel monotherapy or continued DAPT with clopidogrel plus aspirin for 9 months. The primary endpoint of the OPT-BIRISK trial (NCT03431142) was the risk for BARC type 2, 3, or 5 bleeding during the 9-month follow-up.

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 (e.g. age, sex, heart failure, diabetes, renal dysfunction) except in participants with anaemia, 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 (MACCE) 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).

Prof. Renato Lopes (Duke University, NC, USA) congratulated the investigators for providing information on how to manage East-Asian patients with antithrombotic therapy after ACS. He mentioned that the patients had not had a clinical event in the last 9–12 months at the time of randomisation. “Therefore, the population is not likely to be the high-risk population the investigators intended to evaluate. Also, it is important to mention that the results were driven by a reduction in BARC 2, and not BARC 3 or 5 bleeding events, meaning a reduction in less severe bleeding events in the monotherapy arm but not in severe bleeding events. Finally, the applicability of these results in non-Asian patients needs to be further investigated.”

1. 
   
   1. Han Y, et al. Extended clopidogrel monotherapy versus DAPT in high-risk patients: the OPT-BIRISK trial. Hot Line Session 7, ESC Congress 2023, 25–28 August, Amsterdam, the Netherlands.

Copyright ©2023 Medicom Medical Publishers



Posted on 30 October 202313 June 2024