Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction
Second Affiliated Hospital, School of Medicine, Zhejiang University
1,244 participants
May 31, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria7
- 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;
- Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length\<40mm；
- After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection.
- He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form.
Exclusion Criteria10
- 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;
- Non cardiogenic combined lesions show an expected life expectancy of less than one year;
- Left main trunk's stenosis ≥ 50%
- History of coronary artery bypass grafting in the past;
- Intubation or mechanical ventilation status;
- Cardiogenic Shock
- Without signature on informed consent
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Interventions
Drug-coated balloon treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
Drug-eluting stent treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
Locations(1)
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NCT06742125