Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial (BOOST-AMI)

Institute of Cardiovascular Diseases, Vojvodina

Status: Enrolling

Conditions: ST Elevation Myocardial Infarction (STEMI)

Treatments: Device: Drug (paclitaxel) coated balloon (DCB); Device: Second-generation Drug Eluting Stent (DES)

Study type: Interventional

Funder types: Other

Identifiers

NCT06746233

ICDVojvodina 1482-1/3

Details and patient eligibility

About

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.

Enrollment: 598 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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598 participants in 2 patient groups

Drug coated balloon (DCB)

Experimental group

Description:

Drug (paclitaxel) coated balloon (DCB) with concentration of 3 μg Paclitaxel per 1 mm2

Treatment:

Device: Drug (paclitaxel) coated balloon (DCB)

Second generation of drug eluting stents (DES)

Active Comparator group

Description:

Drug eluting stent (DES)

Treatment:

Device: Second-generation Drug Eluting Stent (DES)