Int J Cardiol. 2025 Nov 27:134067. doi: 10.1016/j.ijcard.2025.134067. Online ahead of print.
ABSTRACT
BACKGROUND: Drug-eluting stents have significantly enhanced outcomes of percutaneous coronary intervention (PCI) in coronary artery disease. However, polymer coating used in conventional DES may impair endothelial healing increases the risk of late adverse events. The ISAR SUMMIT polymer-free everolimus-eluting stent, a third-generation DES, aims to address these issues by eliminating the polymer component.
METHODS: This multicenter, prospective registry included patients with acute or chronic coronary syndromes undergoing PCI with ISAR SUMMIT stent in routine clinical practice. We report interim results from the first 500 patients enrolled between August 2022 and September 2023 across 33 Indian centres, with 1-year follow-up. The primary endpoint was target-lesion failure (TLF) at 12 months, defined as a composite of cardiovascular death, clinically driven target-lesion revascularization, and target vessel myocardial infarction.
RESULTS: The study population was predominantly men (78 %), with a mean age of 61.0 ± 10.9 years. Most patients(87.4 %)presented with acute coronary syndromes and common risk factors included arterial hypertension (61.8 %), diabetes (46.0 %), and dyslipidemia (53.0 %). At one year, the incidence of the primary endpoint was 1.0 % (5 patients), including cardiovascular death in 0.8 %, target-vessel myocardial infarction in 0.4 % and clinically driven target-lesion revascularization in 0.2 % of the patients. Definite or probable stent thrombosis was observed in 3 patients (0.6 %).
CONCLUSION: The one-year outcomes in this cohort of patients with a low rate of TLF and stent thrombosis support the favorable safety and efficacy profile of the polymer-free everolimus-eluting ISAR SUMMIT in a real-world Indian population with CAD.
STUDY IDENTIFIERS: CTRI/2022/07/044472.
PMID:41317907 | DOI:10.1016/j.ijcard.2025.134067