Clinical Efficacy and Safety of Selution SLRTM Drug Coated Balloon in Treatment of Patients with ST Elevation Myocardial Infarction.

Abstract

Background: The treatment of ST-elevation myocardial infarction (STEMI) has significantly advanced with the introduction of primary percutaneous coronary intervention (PCI). While primary PCI with drug-eluting stents is widely accepted as the standard treatment, concerns regarding in-stent restenosis and stent thrombosis persist. Drug-coated balloons (DCBs) offer a promising alternative, delivering antiproliferative drugs directly to the vessel walls without leaving any metal behind.

Methods: This clinical registry evaluated the clinical safety and efficacy of the Selution SLR^TM DCB in 36 STEMI patients who underwent primary PCI with Selution SLR^TM DCBs between July 2021 and April 2023 in a tertiary center in Singapore. Immediate angiographic outcomes, procedural details and 12-month clinical outcomes were analyzed.

Results: The mean age of the patients was 56.6 years with male predominance (86.1%). Most patients presented with inferior STEMI (61.1%) and received Selution SLR^TM DCBs primarily in the left circumflex artery (41.7%). No patients required bailout stenting, and most achieved significant luminal gain with < 30% residual stenosis post-PCI. At 12 months, the mortality rate was 11.1%, 5.4% of the patients required target lesion revascularization, and 5.4% had angina.

Conclusions: Our preliminary findings showed that the Selution SLR^TM DCB was safe and effective in primary PCI with low rates of adverse events at 12 months. Further research, including randomized controlled trials, is warranted to corroborate these findings and evaluate long-term outcomes.