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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adult patients admitted with STEMI (symptom onset within 48 hours prior to the procedure) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug-Coated Balloon | Device | Provisional DCB-based pPCI for a de novo coronary |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From January 2014 to April 2026 |
| Measure | Description | Time Frame |
|---|---|---|
| Individual NACE components | Jenuary 2014 to April 2026 | |
| Any Bleeding | Any bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria. | January 2014- April 2026 |
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Inclusion Criteria:
Exclusion Criteria:
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Consecutive adult patients admitted with STEMI
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Riccardo Terzi, MD, BSc | Contact | +393312127467 | riccardo.terzi1@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Rayyan Hemetsberger, MD | Universitatsklinikum AKH wien | Principal Investigator |
| Mohammad Abdelghani, MD, PhD | Sohar Hospital, Sohar, Oman | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitatsklinikum AKH wien | Recruiting | Vienna | Austria |
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|
| 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. | January 2014-April 2026 |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D000072657 | ST Elevation Myocardial Infarction |
| D054058 | Acute Coronary Syndrome |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
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