Extended clopidogrel strategy prevents adverse events in ‘bi-risk’ patients with ACS
Key takeaways:
- Clopidogrel monotherapy after 12-month DAPT reduced risk for adverse events in “bi-risk” patients with ACS vs. extended DAPT.
- “Bi-risk” patients are those with both high bleeding risk and high ischemic risk.
Extended clopidogrel monotherapy after 9-to-12-month dual antiplatelet therapy reduced risk for adverse events in patients with ACS at increased bleeding and ischemic risk who underwent drug-eluting stent implantation, a speaker reported.
The results of the investigator-initiated, double-blind, randomized controlled OPT-BIRISK trial were presented at the European Society of Cardiology Congress.
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“As we know, antiplatelet therapy is a double-edged sword. It reduces ischemic risk but increases bleeding risk. Optimal antiplatelet therapy for ‘bi-risk’ ACS patients remains a clinical challenge and an unsolved problem for the cardiovascular physician,” Yaling Han, professor at the General Hospital of Northern Theater Command in Shenyang, China, said during a press conference. “Therefore, the aim of this trial was to investigate whether extended clopidogrel monotherapy following routine 9 to 12 months of DAPT would be safer and have similar anti ischemic events compared to the extended DAPT strategy for bi-risk ACS patients who were implanted with a coronary DES.”
For this multicenter trial, researchers enrolled a total of 7,758 patients admitted for ACS at high bleeding and ischemic risk — “bi-risk” — at 101 centers in China. All participants received 9 to 12 months DAPT and were subsequently assigned to either clopidogrel monotherapy or continued DAPT for another 9 months.
The primary endpoint was Bleeding Academic Research Consortium type 2, 3 and 5 bleeding. The secondary endpoint was a composite of major adverse cardiac and cerebral events including all-cause death, MI, stroke and revascularization. Other endpoints of interest included the individual components of the secondary endpoint, BARC type 3 and 5 bleeding and stent thrombosis. All endpoints were assessed at 9 months after randomization.
Han said there was a significantly lower rate of clinically relevant bleeding in the clopidogrel monotherapy arm compared with the extended DAPT arm (2.5% vs. 3.3%), translating to a 25% risk reduction among those assigned to clopidogrel monotherapy (HR = 0.75; 95% CI, 0.57-0.97; P = .03).
Similarly, the risk for major adverse cardiac and cerebral events was also lower in the clopidogrel monotherapy arm compared with DAPT (HR = 0.74; 95% CI, 0.57-0.96; P = .02).
For all other endpoints, there were no significant differences between the two groups (P for all > .05).
“For bi-risk ACS patients who complete 9 to 12 months of DAPT after drug-eluting stent implantation, extended 9-month clopidogrel monotherapy regimen was superior to DAPT in reducing clinically relevant bleeding and major ischemic events,” Han said during the press conference.
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Han Y, et al. Hot line 7. Presented at: European Society of Cardiology Congress; Aug. 25-28, 2023; Amsterdam (hybrid meeting).
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