NCT06742125

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,244 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• ST-elevation Myocardial Infarction (STEMI)

Interventions

Type	Name	Description
DEVICE	Drug-coated balloon (DCB)	Drug-coated balloon treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.
DEVICE	Drug-eluting stent (DES)	Drug-eluting stent treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.

Timeline

• Start date: 2025-05-31
• Primary completion: 2032-01-01
• Completion: 2032-01-01
• First posted: 2024-12-19
• Last updated: 2026-01-29

Locations

1 site across 1 country: China