Drug-coated balloon versus drug-eluting stent for treating STEMI

Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction

This study will test whether a drug-coated balloon works as well as a drug-eluting stent for adults with acute ST-elevation myocardial infarction who have successful lesion pretreatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1244 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (Academic / other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT06742125 on ClinicalTrials.gov

What this trial studies

This is an investigator-initiated, open-label, prospective, multicenter randomized non-inferiority trial in China that will randomize 1,244 STEMI patients 1:1 to drug-coated balloon (DCB) or drug-eluting stent (DES) after successful lesion pretreatment. The primary endpoint is a 12-month patient-oriented composite endpoint (POCE) including all-cause death, any myocardial infarction, any stroke, and any revascularization, with follow-up conducted over the study's 2-year participation window. The trial uses a non-inferiority margin of 2.5% with a planned 80% power and Kaplan–Meier survival analysis for event comparison. Enrollment is limited to eligible adults treated at participating tertiary centers with target vessel diameter 2–4 mm and lesion length <40 mm.

Who should consider this trial

Good fit: Adults aged ≥18 with acute STEMI presenting within 48 hours who achieve successful lesion pretreatment and have target vessel diameter 2–4 mm with lesion length under 40 mm are the intended candidates.

Not a fit: Patients with very small (<2 mm) or large (>4 mm) vessels, long lesions (≥40 mm), C-type or worse dissections, heavy residual thrombus, or contraindications/allergies to study medications are unlikely to benefit under this protocol.

Why it matters

Potential benefit: If successful, DCB could provide a "leave-nothing-behind" option that achieves similar 12-month clinical outcomes to DES while avoiding permanent stent implantation and its long-term complications.

How similar studies have performed: Drug-coated balloons have shown favorable results across a range of coronary lesions in prior studies, but randomized evidence specifically for primary PCI in STEMI is limited.

Eligibility criteria

Inclusion Criteria:

1. . Age of Patients ≥18 years old;
2. Acute myocardial infarction patients with onset symptoms\<48 hours require emergency PCI;
3. . 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;
4. Criminal blood vessels with clear requirements for emergency PCI;
5. Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length\<40mm；
6. After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection.
7. He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form.

Exclusion Criteria:

1. 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);
2. The patient has active pathological bleeding;
3. History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia);
4. Patients who are pregnant or have the intention to become pregnant during the period of research;
5. Non cardiogenic combined lesions show an expected life expectancy of less than one year;
6. Left main trunk's stenosis ≥ 50%
7. History of coronary artery bypass grafting in the past;
8. Intubation or mechanical ventilation status;
9. . Cardiogenic Shock
10. . Without signature on informed consent

Where this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Jucheng Zhang

Conditions ST-elevation Myocardial Infarction; Drug-coated balloon; Drug-eluting stent; ST-elevation myocardial infarction