A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.

Official 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.

Study Design

• Study Type: INTERVENTIONAL
• Allocation: RANDOMIZED
• Model: PARALLEL
• Masking: NONE
• Enrollment: 598 participants

Interventions

• DEVICE: Drug (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.
• DEVICE: Second-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

Primary Outcomes

• DoCE (Device-oriented composite endpoint) (1 year and 2 years)

Secondary Outcomes

• Individual components of the primary endpoint (DoCE) (1 year and 2 years)
• Patient-oriented composite endpoint (PoCE) (1 year and 2 years)
• Target vessel revascularization (TVR) (1 year and 2 years)
• Target vessel failure (TVF) (1 year and 2 years)
• BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications. (1 year and 2 years)

Trial Locations

• University Clinical Centre of the Republic of Srpska, Banja Luka, Bosnia and Herzegovina
• University Clinical Centre of Nis, Niš, Serbia, Serbia
• University Clinical Center of Serbia, Belgrade, Serbia
• Institute of Cardiovascular Diseases of Vojvodina, Kamenitz, Serbia
• University Clinical Center of Kragujevac, Kragujevac, Serbia

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