Drug-eluting stent (DES)-based primary percutaneous intervention (pPCI) has been established as the standard of care for patients presenting with ST-segment elevation myocardial infarction (STEMI), having demonstrated superiority over thrombolysis, plain balloon angioplasty, and bare-metal stents. Recently, the use of drug-coated balloons (DCB) has expanded dramatically across a variety of anatomical and clinical settings, including de novo coronary lesions. A DCB-based pPCI strategy may simplify the procedure and mitigate the risks of inadequate stent sizing due to spasm or large thrombus burden, acute stent thrombosis, distal embolization, no reflow, and the relatively higher incidence of late stent-related adverse events compared with elective PCI. Despite these theoretical advantages, data on the safety and efficacy of DCB-based pPCI in STEMI remains limited.
The aim of this registry is to explore procedural and clinical outcomes of patients with STEMI treated with a DCB-based pPCI strategy.
All ST-elevation MI undergoing Primary PCI
In-stent culprit lesion
Contraindications to antiplatelets
Stent implantation within 3 months before enrollment
Cardiac arrest, intubation, or cardiogenic shock
Consecutive adult patients admitted with STEMI
Cohort
Prospective
Drug-Coated Balloon
DeviceProvisional DCB-based pPCI for a de novo coronary
Net adverse clinical events (NACE)
Composite of :Device success, Procedural success, Angiographic success diameter stenosis \<40% by visual estimation and TIMI flow grade ≥2, Target vessel dissection ≥ type C, Bailout stenting
Individual NACE components
Any Bleeding
Any bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria.
Target Vessel Failure (TVF)
Composite of cardiovascular death, target vessel myocardial infarction, or target vessel revascularization, according to Academic Research Consortium drug-coated balloon consensus definitions.
Click on the lead sponsor to view all of their trials.
