Evaluation of Standard Medical Therapy Alone Versus Drug-Eluting Stent Implantation With Medical Therapy in Adults With Acute Myocardial Infarction and Mild Coronary Narrowing

What this Trial Is About

Researchers are conducting a prospective, multicenter, open-label, randomized controlled trial to compare two treatment strategies for adults with acute myocardial infarction AMI who have mild coronary artery narrowing. The study aims to determine if standard medical therapy alone is not worse than using drug-eluting stent DES implantation combined with standard therapy. This trial will include 2,000 patients with ST-segment elevation myocardial infarction STEMI or non-ST-segment elevation myocardial infarction NSTEMI from multiple centers in China. Participants will be randomly assigned to one of two groups one receiving guideline-recommended standard medical therapy alone, which includes dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other related medications and the other receiving DES implantation plus the same standard medical therapy. The study also includes a functional substudy with 120 participants assessing coronary microvascular dysfunction using pressure wire tests. The enrollment period is planned for 36 months, with a follow-up of at least 12 months after randomization and continued monitoring until study completion. During the study, participants will undergo coronary angiography and assessments of vessel function. Researchers will monitor for target lesion failure TLF, defined as cardiovascular death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization, over a median follow-up of 30 months. Additional outcomes include all-cause death, stroke, rehospitalization for heart conditions, and quality of life measures. The study tracks these outcomes through regular follow-up visits to evaluate the safety and effectiveness of the treatment approaches.

Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)