Acute ST-segment elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate intervention. The incidence of premature coronary artery disease (PCAD) is rising rapidly in China; its long-term prognosis remains poor and it frequently progresses to acute myocardial infarction, necessitating high-risk therapies such as primary percutaneous coronary intervention (PCI) or coronary artery bypass grafting, thereby imposing enormous economic and psychological burdens on patients and their families. Moreover, the cumulative 6-year rate of death or myocardial infarction after implantation of the latest-generation drug-eluting stents still reaches 15%, and management of stent failure is extremely challenging. Drug-coated balloon (DCB) angioplasty-representing the "leave-nothing-behind" paradigm-is a highly promising option in young subjects. Accumulating clinical evidence demonstrates that DCB provides favorable efficacy across a broad spectrum of lesions, including small-vessel and large-vessel de novo disease, bifurcation lesions, and in-stent restenosis. Nevertheless, high-quality data on the impact of DCB angioplasty in de novo large-vessel disease and in the setting of acute STEMI are still lacking.
. Age of Patients ≥18 years old;
Acute myocardial infarction patients with onset symptoms<48 hours require emergency PCI;
. Diagnosis: Chest pain and other ischemic symptoms accompanied by ST segment elevation in at least two adjacent leads on electrocardiogram (① V2 or V3 lead: male<40 years ≥ 0.25mV, ≥ 40 years ≥ 0.2mV; Female ≥1.5mV；② Other leads ≥ 1mV), or new left bundle branch block occurs;
Criminal blood vessels with clear requirements for emergency PCI;
The patient has allergies or contraindications to the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, Contrast Medias (Patients with clear contrast agent allergies such as rash but can be controlled with effective drugs such as glucocorticoids and diphenhydramine in advance can be selected);
The patient has active pathological bleeding;
History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia);
Patients who are pregnant or have the intention to become pregnant during the period of research;
Parallel
Drug-coated balloon (DCB)
DeviceDrug-coated balloon treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
Drug-eluting stent (DES)
DeviceDrug-eluting stent treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.
Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)
POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.
Incidence of target vessel failure (Direct measurement and coronary angiography)
Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization) will be obtained through follow-up of subjects.
Incidence of all-cause mortality (Direct measurement)
All-cause mortality will be obtained through follow-up of subjects.
Incidence of non-fatal MI (Direct measurement)
Non-fatal MI will be obtained through follow-up of subjects.
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Second Affiliated Hospital, Zhejiang University, School of Medicine
Lead sponsor
The First Affiliated Hospital of Zhengzhou University
Collaborator
Peking University First Hospital
Collaborator
Suzhou Municipal Hospital
Collaborator
First Affiliated Hospital of Ningbo University
Collaborator
