ST Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
STEMI, DES, DCB
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.
Interventions
DEVICEDrug (paclitaxel) coated balloon (DCB)
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.
DEVICESecond-generation Drug Eluting Stent (DES)
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
Sponsors
Institute of Cardiovascular Diseases, Vojvodina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
Bosnia and Herzegovina, Serbia
Contacts
CONTACTMila Kovačević, MD, PhD
CONTACTBranislav Crnomarković, MD
PRINCIPAL_INVESTIGATORMila Kovačević, MD, PhD
Institute of Cardiovascular Diseases of Vojvodina
Outcome results
None listed