RT Journal Article
A1 Li, Yi
A1 Li, Jing
A1 Wang, Bin
A1 Jing, Quanmin
A1 Zeng, Yujie
A1 Hou, Aijie
A1 Wang, Zhifang
A1 Liu, Aijun
A1 Zhang, Jinliang
A1 Zhang, Yaojun
A1 Zhang, Ping
A1 Jiang, Daming
A1 Liu, Bin
A1 Fan, Jiamao
A1 Zhang, Jun
A1 Li, Li
A1 Su, Guohai
A1 Yang, Ming
A1 Jiang, Weihong
A1 Qu, Peng
A1 Zeng, Hesong
A1 Li, Lu
A1 Qiu, Miaohan
A1 Ru, Leisheng
A1 Chen, Shaoliang
A1 Zhou, Yujie
A1 Qiao, Shubin
A1 Stone, Gregg W.
A1 Angiolillo, Dominick J.
A1 Han, Yaling
A1 OPT-BIRISK Investigators
T1 Extended Clopidogrel Monotherapy vs DAPT in Patients With Acute Coronary Syndromes at High Ischemic and Bleeding Risk: The OPT-BIRISK Randomized Clinical Trial
JF JAMA Cardiology
JO JAMA Cardiol
YR 2024
DO 10.1001/jamacardio.2024.0534
SN 2380-6583
AB Purinergic receptor P2Y12 (P2Y12) inhibitor monotherapy after a certain period of dual antiplatelet therapy (DAPT) may be an attractive option of maintenance antiplatelet treatment for patients undergoing percutaneous coronary intervention (PCI) who are at both high bleeding and ischemic risk (birisk).To determine if extended P2Y12 inhibitor monotherapy with clopidogrel is superior to ongoing DAPT with aspirin and clopidogrel after 9 to 12 months of DAPT after PCI in birisk patients with acute coronary syndromes (ACS).This was a multicenter, double-blind, placebo-controlled, randomized clinical trial including birisk patients with ACS who had completed 9 to 12 months of DAPT after drug-eluting stent implantation and were free from adverse events for at least 6 months at 101 China centers between February 2018 and December 2020. Study data were analyzed from April 2023 to May 2023.Patients were randomized either to clopidogrel plus placebo or clopidogrel plus aspirin for an additional 9 months.The primary end point was Bleeding Academic Research Consortium (BARC) types 2, 3, or 5 bleeding 9 months after randomization. The key secondary end point was major adverse cardiac and cerebral events (MACCE; the composite of all-cause death, myocardial infarction, stroke or clinically driven revascularization). The primary end point was tested for superiority, and the MACCE end point was tested for sequential noninferiority and superiority.A total of 7758 patients (mean [SD] age, 64.8 [9.0] years; 4575 male [59.0%]) were included in this study. The primary end point of BARC types 2, 3, or 5 bleeding occurred in 95 of 3873 patients (2.5%) assigned to clopidogrel plus placebo and 127 of 3885 patients (3.3%) assigned to clopidogrel plus aspirin (hazard ratio [HR], 0.75; 95% CI, 0.57-0.97; difference, −0.8%; 95% CI, −1.6% to −0.1%; P = .03). The incidence of MACCE was 2.6% (101 of 3873 patients) in the clopidogrel plus placebo group and 3.5% (136 of 3885 patients) in the clopidogrel plus aspirin group (HR, 0.74; 95% CI, 0.57-0.96; difference, −0.9%; 95% CI, −1.7% to −0.1%; P < .001 for noninferiority; P = .02 for superiority).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.ClinicalTrials.gov Identifier: NCT03431142
RD 6/2/2024
UL https://doi.org/10.1001/jamacardio.2024.0534