Real-World Clinical Outcomes of Indigenous Biodegradable Polymer Drug-Eluting Stents.

Abstract

IntroductionThe durable polymer has been shown to cause neoatherosclerosis, and chronic local inflammation, predisposing individuals to in-stent restenosis and stent thrombosis (ST). The biodegradable polymer stents, which degrade after the desired function of drug release is achieved, allow for endothelial healing. Indigenous coronary stent manufacturing and its use are on the rise nowadays, and their safety and efficacy have been studied in well-structured clinical trials. However, data are scarce on their safety and efficacy in the real-world clinical setting. In this study, we examine the real-world one-year performance of bioresorbable or polymer-free stents manufactured in India.Materials and methodsThis was a single-center, single-arm prospective observational study involving 210 patients undergoing intracoronary stenting using bioabsorbable or polymer-free drug-eluting stents (DES) from Indian manufacturers. All patients were followed up for 12 months prospectively for any major clinical events.ResultsThe mean age of the enrolled patients was 57.04 years (IQR: 34-84 years), among which 159 (75.7%) were male; 99 (43.8%) patients had presented with acute myocardial infarction (MI). A total of 294 stents were deployed with a mean diameter of 3.1 ±0.4 mm, and a mean length of 29.4 ±9.1 mm. Two patients had experienced major adverse cardiovascular events (MACE). After three months of follow-up, one patient developed ST, and the same patient developed a cerebrovascular accident (CVA) after six months. After one year of follow-up, one patient died of cardiac causes.ConclusionBased on our findings, in the real-world clinical setting, the indigenously made biodegradable polymer DES are both safe and effective.