Clinical & Experimental Cardiology
Open Access

Abstract

Clinical Outcomes of the Eucalimus Sirolimus-Eluting Coronary Stent System with a Biodegradable Polymer in All-Comers Coronary Artery Disease Patients: Results from Registry in Greece

Bampas Georgios, Papakonstantinou Dimitrios, Tsounos Ioannis, Papazahariou Sotirios, Moshovitis Aris and Tsialoukis Panagiotis Malakoudis Eleftherio*

Background: Biodegradable polymer drug-eluting stents with biodegradable polymer coatings have shown reduced restenosis rates and low rates of stent thrombosis. The present post marketing retrospective study assessed clinical outcomes of patients who had received eucaLimus DES in real practice.

Aim: To investigate 2-year clinical outcomes of eucaLimus DES in real practice.

Methods: Data obtained from a two-center cohort of patients who had received eucaLimus stents between February 2016 to September 2018 as part of routine treatment of Coronary Artery Disease (CAD) were retrospectively investigated at follow-up of 27.8 months ± 5.2 months. The primary study endpoint was to determine the rate of Target Lesion Failure (TLF) defined as the aggregate of cardiac death, target vessel Q-wave or non Q-wave Myocardial Infarction (MI), and TLR procedure during the follow-up period after the index procedure. Secondary endpoint was MACE defined as the composite of all-cause mortality, any MI and any repeat revascularization (includes all target and non-target vessel). The Stent Thrombosis (ST) was also evaluated in this study and was classified according to the definitions of the Academic Research Consortium.

Results: A total of 196 patients with 253 lesions were enrolled. The most common comorbid conditions were hypertension (43.4%), diabetes mellitus (27.5%), hyperlipidemia (54.6%) and smoking (60.7%). Procedural success was achieved in all patients and no in-hospital MACE was reported. The incidence of composite TLF at follow-up was 4.0%. The MACE rate shows 8.6 % including non-cardiac death (2%), myocard infarction not related to target vessel (1%). Beside one sub-acute thrombosis the rate of late or very late stent thrombosis was 0%.

Conclusion: Compared to the mid-term follow-up the relatively low rates of TFL and MACE and non-late or very late stent thrombosis in this study support safety and performance of eucaLimus stents, suggesting it to be an effective alternative to other contemporary stents for the treatment of de novo lesions in native coronary arteries.e.

Published Date: 2022-01-06; Received Date: 2021-12-09