Volume 24 No 2 (2026)
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TWELVE-MONTH SAFETY AND EFFECTIVENESS OF A NOVEL BIODEGRADABLE POLYMER SIROLIMUS-ELUTING CORONARY STENT IN CLINICAL PRACTICE
DR. SURESH. M.K, DR. VIKASH. M
Abstract
Introduction: Coronary artery disease (CAD) remains the top cause of death worldwide.1 In recent years, drug-eluting stents (DES) have become the preferred treatment for most patients undergoing percutaneous coronary intervention (PCI).2 These stents are utilized in various clinical and anatomical scenarios due to their significant reduction in restenosis rates and the decreased necessity for repeat revascularization. Objectives: The objective of this study was to evaluate the safety and efficacy of the Stenoflex Sirolimus-Eluting Coronary Stent System (SES) in a cohort of all-comer patients with coronary artery disease (CAD) over a one-year clinical follow-up period. Methods: This investigation was a single-center, observational, post-marketing study involving 92 patients with CAD who received the Stenoflex SES at a tertiary cardiac center in Southern Tamil Nadu, India. The primary endpoint was the incidence of major adverse cardiac events (MACE) at one year, defined as a composite of cardiac death, myocardial infarction (MI), and target lesion revascularization (TLR). Clinical follow-up assessments were conducted at 1, 6, and 12 months. The occurrence of MACE at 30 days, 6 months, and at the one-year follow-up was analyzed. Results: The incidence of MACE at 1 and 6 months was 1 (0.01%) and 1 (0.01%), respectively. The cumulative one-year MACE rate was 1 (0.01%), with 1 (0.01%) all-cause mortality. There were no instances of MI, TLR, or stent thrombosis (ST) during the study period. The MACE observed at one month was attributed to ventricular arrhythmia resulting in sudden cardiac death. Conclusions: The findings of this study suggest that the Stenoflex SES is safe and effective in a "real-world" population of all-comer CAD patients, demonstrating low rates of MACE. Keywords: Biodegradable polymer
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