Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial

Not Applicable

Recruiting

• Conditions: ST Elevation Myocardial Infarction (STEMI)

• Registration Number: NCT06746233
• Lead Sponsor: Institute of Cardiovascular Diseases, Vojvodina

Brief Summary

The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).

Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-12-13
• Study First Submitted QC: 2024-12-19
• Study Start: 2024-12-25
• Status Verified: 2025-03
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-30
• Last Update Posted: 2025-04-01
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 598

Inclusion Criteria

• Age >18 years with a life expectancy of >1 year;
• Patients fulfilling criteria for STEMI (>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms)
• Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.

Exclusion Criteria

• Killip class>II on admission
• Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor
• Previous myocardial infarction
• Previous PCI in the territory of the infarct-related artery (IRA)
• Previous CABG
• 3-vessel disease requiring revascularization
• Left-main disease
• Extremely angulated or severely calcified vessels
• History of ischemic stroke within the past 6 months or hemorrhagic stroke
• Planned CABG for a non-culprit vessel
• Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
DoCE (Device-oriented composite endpoint)	1 year and 2 years	DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).

Secondary Outcome Measures

Name	Time	Method
Individual components of the primary endpoint (DoCE)	1 year and 2 years	Individual components of the primary endpoint (DoCE): * Cardiac mortality; * Non-fatal target vessel myocardial infarction (NF-TVMI); * Target lesion revascularization (TLR)
Patient-oriented composite endpoint (PoCE)	1 year and 2 years	PoCE: Defined as a composite of all-cause death, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.
Target vessel revascularization (TVR)	1 year and 2 years
Target vessel failure (TVF)	1 year and 2 years	Target Vessel Failure (TVF): Defined as a composite of cardiac death, target vessel myocardial infarction (MI), and clinically or physiologically indicated target vessel revascularization (TVR).
BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.	1 year and 2 years

Trial Locations

Locations (4)

University Clinical Center of Kragujevac; 🇷🇸 Kragujevac, Serbia

University Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

University Clinical Centre of Nis; 🇷🇸 Niš, Serbia

Institute of Cardiovascular Diseases of Vojvodina; 🇷🇸 Sremska Kamenica, Serbia