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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
598
In 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.
In 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
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
RECRUITINGUniversity Clinical Centre of Nis
Niš, Serbia, Serbia
NOT_YET_RECRUITINGUniversity Clinical Center of Serbia
Belgrade, Serbia
RECRUITINGInstitute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia
RECRUITINGUniversity Clinical Center of Kragujevac
Kragujevac, Serbia
NOT_YET_RECRUITINGDoCE (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).
Time frame: 1 year and 2 years
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)
Time frame: 1 year and 2 years
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.
Time frame: 1 year and 2 years
Target vessel revascularization (TVR)
Time frame: 1 year and 2 years
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).
Time frame: 1 year and 2 years
BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.
Time frame: 1 year and 2 years
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