Safety and Efficacy of a Novel Everolimus-Eluting Stent System in “Real-World” Patients with Coronary Artery Disease: A Report of Preliminary Outcomes

Abstract

Introduction: Tetrilimus (Sahajanand Medical Technologies Pvt. Ltd., Surat, India) is a recently-introduced biodegradable-polymer coated everolimus-eluting cobaltchromium coronary stent system with an ultra-thin strut thickness. We aimed to evaluate the clinical outcomes with Tetrilimus coronary stents in "real-world" patients with coronary artery disease. Methods: In this retrospective, single-arm, openlabel, multi-center registry, all consecutive patients who received Tetrilimus stents between July-2015 and April-2016 at two tertiary-care centers in India were analyzed. Primary endpoint was 30-day incidence of major adverse cardiac events (MACE), defined as a composite of cardiac death, myocardial infarction, target lesion revascularization, and target vessel revascularization. The Academic Research Consortium (ARC)-defined stent thrombosis was assessed as additional safety endpoint. Results: During the study period, 280 Tetrilimus stents (1.4 ± 0.5 stent/patient) were implanted to treat 252 coronary lesions (1.1 ± 0.3 stent/lesion) in 208 patients (age: 57.5 ± 11.9 years). Of study population, 65.9% were males, 46.6% were hypertensives, 25% were diabetics, 36.5% were alcoholics, 29.3% were smokers, 13.9% were tobacco chewers, 5.3% had previous revascularization, and 45.2% displayed multi-vessel disease. Of treated lesions, 67.5% were complex and 18.7% had total occlusion. Average length and diameter of implanted stents were 25.5 ± 8.8 mm and 2.9 ± 0.3 mm respectively. Subsequently, 30-day MACE were reported in 2 (0.96%) patients; both cases owing to in-hospital cardiac deaths. Events of stent thrombosis or noncardiac death were not reported in any patient. Conclusion: Low MACE rates and absence of stent thrombosis at early 30-day follow-up indicates that Tetrilimus everolimus

Ultrathin, biodegradable polymer-coated everolimus-eluting stents for patients undergoing percutaneous coronary intervention: Final three-year results of the PERFORM-EVER registry

“…In addition to ultrathin platform of Tetrilimus EES, its unique biodegradable polymer-coating, novel LDZ-link (making it more flexible and deliverable) and wide range of available size matrix (making it suitable for small vessels [<2.5 mm] as well as long lesions [>40 mm]) demonstrates favorable long-term safety and effectiveness as reported in the current and in the previous studies. 14 , 15 , 16 , 17 , 18 , 28 …”

“…Tetrilimus (Sahajanand Medical Technologies Ltd., Surat, India), an everolimus-eluting stent (EES), is a latest generation DES with biodegradable polymer-coating on an ultrathin (60 μm) cobalt-chromium platform with unique long-dual Z (LDZ) link connectors. The safety and effectiveness of Tetrilimus EES have previously been reported in several studies, 14 , 15 , 16 , 17 , 18 but there are inadequate long-term clinical data (>1 year after implantation) on this latest generation ultrathin DES. 19 Specifically, there is a need to establish whether Tetrilimus EES can overcome the limitations of earlier generation DES, like late in-stent restenosis and very late stent thrombosis.…”

Serial evaluation of vascular responses after implantation of everolimus‐eluting coronary stent by optical coherence tomography

“…The specifications of Tetrilimus stent have been mentioned in detail previously 8 . It is a cobalt‐chromium platform DES, coated on both surfaces with a mixture of biodegradable polymers like poly‐L‐lactide (PLLA), poly‐L‐lactide‐co‐caprolactone (PLCL), poly vinyl pyrrolidone (PVP).…”

Drug eluting stents versus bare metal stents in coronary artery disease patients: outcomes and complications

“…1 DESs are the milestone development in the field of interventional cardiology. 5 The clinical presentation of the restenosis process was most often associated with the recurrence of angina and doesn't lead to any cause of death or myocardial infarction. 6 However, DES has been shown to reduce the neointimal proliferation and thereby lowering the need for in-stent restenosis as compared with BMS.…”

“…Biodegradable polymers have been developed as an answer to this problem. 5 An early invasive strategy by urgent re-PCI represents the most adopted strategy to manage patients presenting with ST. However, despite its evident clinical relevance, available data derived from sub-studies on the ST was still lacking.…”