A SYSTEMATIC REVIEW ONSAFETY AND EFFICACY OF INDIGENOUS ULTRATHIN-STRUT VERSUS INTERNATIONAL THIN-STRUT DRUG-ELUTING CORONARY STENTS IN PERCUTANEOUS CORONARY INTERVENTION...
Author(s)
Ashutosh V. Bhosale, PhD Scholar1, Mohammed Salim Karattuthodi, PhD in Pharmacy Practice2, Shivaprakash Gangachannaiah, MBBS, MD, Pharmacology3, Girish Thunga, PhD in Pharmacy Practice4, Rajesh Radhakrishnan, PhD in Pharmacy Practice5.
1Student, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Department of Pharmacy Practice,, College of Pharmacy (CoP), Gulf Medical University (GMU), Ajman, UAE, Ajman UAE, United Arab Emirates, 3Department of Pharmacology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India, 4Department of Pharmacy Practice,, Manipal college of pharmaceutical sciences, Manipal, India, 5Manipal College of Pharmaceutical Sciences, Academy of Higher Education, Manipal, India.
1Student, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal, India, 2Department of Pharmacy Practice,, College of Pharmacy (CoP), Gulf Medical University (GMU), Ajman, UAE, Ajman UAE, United Arab Emirates, 3Department of Pharmacology, Kasturba Medical College, Manipal Academy of Higher Education, Manipal, India, 4Department of Pharmacy Practice,, Manipal college of pharmaceutical sciences, Manipal, India, 5Manipal College of Pharmaceutical Sciences, Academy of Higher Education, Manipal, India.
OBJECTIVES: Objective: To systematically evaluate the safety and efficacy of indigenous ultrathin-strut drug-eluting coronary stents compared with internationally manufactured thin-strut DES in patients undergoing PCI.
METHODS: Methods: A systematic review 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 10th December 2025. Randomized controlled trials comparing indigenous ultrathin-strut DES with internationally manufactured thin-strut DES in adult patients undergoing PCI were included. Primary outcomes were major adverse cardiac events or trial-defined composite endpoints. Secondary outcomes included target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis, cardiac death, and all-cause mortality. Risk of bias was assessed using the Cochrane RoB-2 tool. Due to clinical and methodological heterogeneity, a narrative synthesis was performed.
RESULTS: Results: Four randomized controlled trials involving 2,793 patients were included. The indigenous stents evaluated were Supraflex Cruz, Supraflex, and BioMime, while the comparator stents were Xience, Ultimaster, and Ultimaster Tansei. Across studies, primary composite endpoints were comparable between treatment groups. Net adverse clinical events occurred in 15.4% versus 17.1% in the COMPARE 60/80 HBR trial. Device-oriented composite endpoint rates were 4.9% versus 5.3% in the TALENT trial. Target vessel failure was 16.39% versus 10.48% in the STEMI trial, while three-point major adverse cardiac events occurred in 6.5% versus 8.3% in the meriT-V trial. Individual outcomes including myocardial infarction, repeat revascularization, and stent thrombosis were low and comparable between groups.
CONCLUSIONS: Conclusion: Indigenous ultrathin-strut biodegradable-polymer DES demonstrate safety and efficacy comparable to internationally manufactured thin-strut DES across diverse PCI populations. Clinical outcomes including MACE, myocardial infarction, repeat revascularization, and stent thrombosis were low and comparable between stent platforms. However, larger trials with longer follow-up and real-world materiovigilance surveillance studies are warranted.
METHODS: Methods: A systematic review 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 10th December 2025. Randomized controlled trials comparing indigenous ultrathin-strut DES with internationally manufactured thin-strut DES in adult patients undergoing PCI were included. Primary outcomes were major adverse cardiac events or trial-defined composite endpoints. Secondary outcomes included target lesion revascularization, target vessel revascularization, myocardial infarction, stent thrombosis, cardiac death, and all-cause mortality. Risk of bias was assessed using the Cochrane RoB-2 tool. Due to clinical and methodological heterogeneity, a narrative synthesis was performed.
RESULTS: Results: Four randomized controlled trials involving 2,793 patients were included. The indigenous stents evaluated were Supraflex Cruz, Supraflex, and BioMime, while the comparator stents were Xience, Ultimaster, and Ultimaster Tansei. Across studies, primary composite endpoints were comparable between treatment groups. Net adverse clinical events occurred in 15.4% versus 17.1% in the COMPARE 60/80 HBR trial. Device-oriented composite endpoint rates were 4.9% versus 5.3% in the TALENT trial. Target vessel failure was 16.39% versus 10.48% in the STEMI trial, while three-point major adverse cardiac events occurred in 6.5% versus 8.3% in the meriT-V trial. Individual outcomes including myocardial infarction, repeat revascularization, and stent thrombosis were low and comparable between groups.
CONCLUSIONS: Conclusion: Indigenous ultrathin-strut biodegradable-polymer DES demonstrate safety and efficacy comparable to internationally manufactured thin-strut DES across diverse PCI populations. Clinical outcomes including MACE, myocardial infarction, repeat revascularization, and stent thrombosis were low and comparable between stent platforms. However, larger trials with longer follow-up and real-world materiovigilance surveillance studies are warranted.
Conference/Value in Health Info
2026-09, ISPOR Asia Pacific 2026, Bangkok, Thailand
Value in Health, Volume 55, Issue S1
Code
CO1
Topic
Clinical Outcomes
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
SDC: Cardiovascular Disorders (including MI, Stroke, Circulatory)