ISSN 2149-2263 | E-ISSN 2149-2271
The Anatolian Journal of Cardiology
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Safety and Clinical Performance of Biodegradable Polymer-Coated Ultra-Thin Everolimus-Eluting Stents in “Real-World” Patients: A Multicenter Registry (PERFORM-EVER) [Anatol J Cardiol]
Anatol J Cardiol. 2022; 26(8): 619-628 | DOI: 10.5152/AnatolJCardiol.2022.844

Safety and Clinical Performance of Biodegradable Polymer-Coated Ultra-Thin Everolimus-Eluting Stents in “Real-World” Patients: A Multicenter Registry (PERFORM-EVER)

Sridhar Kasturi1, Srinivas Polasa2, Mohammad Ali Sowdagar3, Praveen Kumar3, Thejanandan Reddy3, Chaitanya Nichenamatla3, Shailender Singh1, Vijaykumar Reddy1
1Sunshine Heart Institute, Secunderabad, India
2Chalmeda Anandrao Institute of Medical Sciences, Karimnagar, India
3Gowri Gopal Hospital, Kurnool, India

Background: Tetrilimus (Sahajanand Medical Technologies Limited, Surat, India) is a biodegradable polymer-coated everolimus-eluting stent with cobalt–chromium stent platform and ultra-thin (60 µm) strut thickness. We aimed to report 1-year safety and clinical performance of Tetrilimus everolimus-eluting stent in patients with coronary artery disease in “real-world” clinical practice.

Methods: The PERFORMance of biodegradable polymer-coated ultra-thin EVERolimuseluting stents was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. All “real-world” patients who had received Tetrilimus everolimuseluting stent between July-2015 and October-2016 at four study centers were analyzed. The data were collected retrospectively either by extraction from existing databases in consecutive fashion where index and follow-up data existed or the follow-up was obtained by telephonic contact. Primary endpoint was 1-year incidence of target lesion failure, which was defined as a composite endpoint of cardiac death, myocardial infarction, and target lesion revascularization by percutaneous or surgical methods. The Academic Research Consortium-defined stent thrombosis was assessed as additional safety endpoint.

Results: During the study period, 815 Tetrilimus everolimus-eluting stents (1.4 ± 0.5 stent/ patient) were implanted to treat 735 coronary lesions (1.1 ± 0.3 stent/lesion) in 594 patients (mean age: 55.6 ± 12.1 years). The cumulative incidence of target lesion failure at 1-year follow-up was 3.7%, which included 9 (1.5%) cardiac deaths, 8 (1.4%) myocardial infarctions, and 5 (0.8%) target lesion revascularizations. There were 5 (0.8%) cases of probable stent thrombosis and 4 (0.7%) cases of possible stent thrombosis at 1-year follow-up.

Conclusion: Low incidences of target lesion failure and stent thrombosis at 1-year followup indicates that biodegradable polymer-coated ultra-thin Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected real-world patients with coronary artery disease, including those with high-risk characteristics and complex lesions.

Keywords: Biodegradable polymer, everolimus-eluting stent, percutaneous coronary intervention, stent thrombosis, target lesion failure, ultra-thin strut

Sridhar Kasturi, Srinivas Polasa, Mohammad Ali Sowdagar, Praveen Kumar, Thejanandan Reddy, Chaitanya Nichenamatla, Shailender Singh, Vijaykumar Reddy. Safety and Clinical Performance of Biodegradable Polymer-Coated Ultra-Thin Everolimus-Eluting Stents in “Real-World” Patients: A Multicenter Registry (PERFORM-EVER). Anatol J Cardiol. 2022; 26(8): 619-628

Corresponding Author: Sridhar Kasturi
Manuscript Language: English


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