OPT-BIRISK: Extended P2Y12 Inhibitor Monotherapy Post-PCI Reduced Bleeding and Ischemic Events in ACS Patients

An extended course of P2Y12 inhibitor monotherapy beyond 12 months after PCI reduced bleeding and ischemic events in patients with acute coronary syndrome (ACS) at high risk for both types of events, according to findings from the OPT-BIRISK trial presented at ESC Congress 2023.

A total of 7,758 patients with ACS were randomized at 101 Chinese centers between February 2018 and December 2020 to receive either clopidogrel (75 mg/day) plus placebo or clopidogrel (75 mg/day) plus aspirin (100 mg/day). All received aspirin monotherapy (100 mg/day) for an additional three months to exclude rebound events. Follow-up was performed at three, six, nine and 12 months after randomization.

In terms of demographics, all participants had completed nine to 12 months of DAPT after drug-eluting stent implantation for the treatment of ACS, were free from major adverse clinical events during the prior six months and were at both high-bleeding and ischemic risk. The mean age of participants was 65 years and 41% were women.

The primary endpoint of clinically relevant bleeding at nine months after randomization, occurred in 95 patients (2.5%) assigned to clopidogrel plus placebo compared with 127 patients (3.3%) assigned to clopidogrel plus aspirin. The key secondary endpoint of major adverse cardiac and cerebral events (MACCE) at nine months occurred in 101 patients (2.6%) in the clopidogrel plus placebo group compared with 136 patients (3.5%) in the clopidogrel plus aspirin group. The incidences of all-cause death, myocardial infarction, stroke, clinically-driven revascularization and stent thrombosis were not significantly different between the two groups, according to investigators.

"Among ACS patients at high risk for both recurrent ischemic and bleeding events after PCI who had completed a nine to 12 month standard course of DAPT and were free from major events, a strategy of extended P2Y12 inhibitor monotherapy with clopidogrel for an additional nine months was superior to DAPT with aspirin and clopidogrel for reducing clinically-relevant bleeding and ischemic events," said Yaling Han, MD, PhD, FACC, of the General Hospital of Northern Theater Command, Shenyang, China. "The increased rate of MACCE in the clopidogrel plus aspirin group was surprising."

Clinical Topics: Acute Coronary Syndromes

Keywords: ESC Congress, ESC23, ACC International, Platelet Aggregation Inhibitors, Acute Coronary Syndrome

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