Clopidogrel or Dual Antiplatelet Therapy in High-Ischemic-Risk Patients.

Not reported in abstract.

Summary and findings

Not reported in abstract.

Abstract

Background The effect of clopidogrel monotherapy as compared with extended dual antiplatelet therapy (DAPT) with clopidogrel and aspirin beyond 12 months after implantation of a drug-eluting stent remains uncertain in patients at high risk for recurrent ischemic events. Methods In this open-label noninferiority trial conducted in South Korea, we enrolled patients with high-risk clinical or lesion characteristics in whom a drug-eluting stent had been implanted 12 months earlier and randomly assigned them, in a 1:1 ratio, to receive clopidogrel monotherapy or extended DAPT (clopidogrel plus aspirin). The primary end point was net adverse clinical events, a composite of death from any cause, myocardial infarction, stent thrombosis, stroke, or Bleeding Academic Research Consortium (BARC) type 2, 3, or 5 bleeding at 24 months (noninferiority margin, 2.3 percentage points). Key secondary ischemic and bleeding end points were tested in a prespecified hierarchical order. Results Of the 3203 patients who underwent randomization, 1601 were assigned to receive clopidogrel monotherapy and 1602 to receive extended DAPT. Over the course of 24 months, a primary end-point event occurred in 80 patients (5.0%) in the monotherapy group and in 81 (5.1%) in the DAPT group (risk difference, -0.1 percentage points; 90% confidence interval [CI], -1.3 to 1.2; P = 0.001 for noninferiority). Death from any cause, myocardial infarction, stent thrombosis, or stroke (the key secondary ischemic end point) occurred in 60 patients (3.7%) in the monotherapy group and in 26 (1.6%) in the DAPT group (hazard ratio, 2.33; 95% CI, 1.47 to 3.69; P<0.001). BARC type 2, 3, or 5 bleeding (the key secondary bleeding end point) occurred in 28 patients (1.8%) in the monotherapy group and in 65 (4.1%) in the DAPT group (hazard ratio, 0.43; 95% CI, 0.27 to 0.67; P<0.001). The incidence of serious adverse events was similar in the two groups. Conclusions Among patients at high risk for ischemic events 12 months after drug-eluting stent implantation, clopidogrel monotherapy was noninferior to extended DAPT with respect to net adverse clinical events at 24 months. (Funded by Chong Kun Dang and Samjin; A-CLOSE ClinicalTrials.gov number, NCT03947229.).

Limitations

Not reported in abstract.

Elsewhere in the Mazdutide (IBI362) corpus