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.
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.
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)
Parallel
Drug (paclitaxel) coated balloon (DCB)
DeviceIn the experimental arm, a paclitaxel-coated balloon (DCB) delivering 3.0-3.5 µg/mm² will be used in STEMI patients after successful lesion preparation (defined as residual stenosis ≤30%, TIMI flow grade 2-3, and absence of flow-limiting dissection). If the result after DCB treatment is unsatisfactory, bailout implantation of a drug-eluting stent (DES) will be performed at the operator's discretion.
Second-generation Drug Eluting Stent (DES)
DeviceIn the control arm, patients randomized to the DES treatment group will undergo implantation of a second-generation drug-eluting stent (DES) using standard techniques, according to current practice guidelines
DoCE (Device-oriented composite endpoint)
DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).
Individual components of the primary endpoint (DoCE)
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)
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)
Target vessel failure (TVF)
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).
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Institute of Cardiovascular Diseases, Vojvodina
Lead sponsor
University of Novi Sad
Sponsor institution