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

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.

Conditions

• ST-elevation Myocardial Infarction (STEMI)

Interventions

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.

Sponsors & Collaborators

• The First Affiliated Hospital of Zhengzhou University

  collaborator OTHER

• Peking University First Hospital

  collaborator OTHER

• Suzhou Municipal Hospital

  collaborator OTHER

• First Affiliated Hospital of Ningbo University

  collaborator NETWORK

• Second Affiliated Hospital, School of Medicine, Zhejiang University

  lead OTHER

Principal Investigators

• Jun Jiang · Second Affiliated Hospital, School of Medicine, Zhejiang University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-31

Primary Completion

2032-01-01

Completion

2032-01-01

Countries

• China

Study Locations