Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction (DCB-STEMI)

Zhejiang University

Status: Enrolling

Conditions: ST-elevation Myocardial Infarction (STEMI)

Treatments: Device: Drug-eluting stent (DES); Device: Drug-coated balloon (DCB)

Study type: Interventional

Funder types: Other; NETWORK

Identifiers

NCT06742125

2024-0936

Details and patient eligibility

About

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.

Full description

Objectives of Study:

Compare the clinical outcomes of drug-coated balloon (DCB) and drug-eluting stent (DES) treatment in patients with ST-segment elevation myocardial infarction (STEMI).

Design of Study:

Investigator-Initiated，Open Label，Prospective，Multicenter，Randomized Clinical Trial.

Patients Selected： This study aims to STEMI patients who have successfully completed lesion pretreatment in multiple medical centers in China. Patients who meet the inclusion criteria and have no exclusion criteria will be randomly assigned 1:1 to the drug coated balloon group and drug eluting stent group, totaling 1244 cases (622 cases per group).

Primary Endpoints:

Patient-oriented composite endpoints (POCE) within 12 months, including all-cause mortality, any myocardial infarction, any stroke, and any revascularization.

Hypothesis:

The 12-month POCE rate in the DCB group of STEMI patients is not inferior to that of the DES group.

Sample's Size:

Sample size calculation based on the event rates of previous trials. DES group had a predetermined events' rate of 8.0%, the DCB group had a predetermined events' rate of 6.3%.

• Design: Non-inferiority, delta=2.5%
• Ratio of Specimen: DCB : DES= 1:1
• Type I Error (α): Single side 2.5%
• Duration of Participation: 2 years
• Setting: The 12-month clinical events' rates for the DCB group and DES group were 6.3% and 8.0%, respectively.
• Statistical Testing Efficiency (1- β): 80%
• Main Statistical Methods: Kaplan-meier survival analysis using log rank testing
• Dropout Rate: 5% of all the patients Based on the above assumptions and dropout rate, we need to include a total of 1244 cases (622 cases per group).

Enrollment: 1,244 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,244 participants in 2 patient groups

DCB group

Experimental group

Description:

STEMI patients undergo revascularization using DCB

Treatment:

Device: Drug-coated balloon (DCB)

DES group

Active Comparator group

Description:

STEMI patients undergo revascularization using DES

Treatment:

Device: Drug-eluting stent (DES)