Safety and efficacy of indigenous ultrathin-strut versus international thin-strut drug-eluting coronary stents in percutaneous coronary intervention: a systematic review of randomized controlled trials
Year: 2026
Type: review
Study design: Systematic Review
Abstract: INTRODUCTION: Ultrathin-strut drug-eluting stents (DES) have been developed to enhance vascular healing and reduce restenosis following percutaneous coronary intervention (PCI). Indigenous biodegradable-polymer ultrathin-strut DES are increasingly used in high-burden settings; however, comparative evidence against internationally established thin-strut DES remains limited. METHODS: This systematic review of randomized controlled trials was conducted according to PRISMA 2020 guidelines. PubMed, Embase, Scopus, Web of Science, and the Cochrane Central Register of Controlled Trials were searched from inception to December 2025. Trials comparing indigenous ultrathin-strut DES with internationally manufactured thin-strut DES in adult PCI populations were included. Primary outcomes were major adverse cardiac events/trial-defined composite endpoints. Secondary outcomes included myocardial infarction, target lesion and vessel revascularization, stent thrombosis, cardiac death, and all-cause mortality. Risk of bias was assessed using the Cochrane RoB-2 tool, and a narrative synthesis was performed. RESULTS: Four randomized trials including 2,793 patients were analyzed. Indigenous stents demonstrated comparable rates of composite endpoints, myocardial infarction, repeat revascularization, and stent thrombosis across studies, with no consistent differences between groups. CONCLUSION: The available RCT evidence shows no consistent signal of superiority or inferiority between indigenous and international thin-strut DES. However, heterogeneity and limited trial numbers warrant larger studies with long-term follow-up and real-world materiovigilance. PROTOCOL REGISTRATION: CRD420251240469.
Source: Expert Review of Medical Devices
Institutions: Manipal Academy of Higher Education, National Institute of Pharmaceutical Education and Research - Ahmedabad, National Institute of Pharmaceutical Education and Research, National Institute of Pharmaceutical Education and Research, National Institute of Pharmaceutical Education and Research, Gulf Medical University, Kasturba Medical College, Manipal, Post Graduate Institute of Medical Education and Research, Government of India, Ministry of Health and Family Welfare, D.Y. Patil University, National Institute of Pharmaceutical Education and Research, National Institute of Pharmaceutical Education and Research, National Institute of Pharmaceutical Education and Research
Language: English
Subfield: Surgery
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
OpenAlex ID: W7220837226