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In the contemporary practice, the use of drug-eluting stents is associated with low mortality benefits, restenosis and stent thrombosis. To address these issues, third-generation, ultra-thin, biodegradable polymer-coated stents has been designed. The aim of the study is to assess safety and efficacy of the Everoflex (Sahajanand Medical Technologies Pvt. Ltd., Surat, India), third-generation, ultra-thin (60 μm), biodegradable polymer-coated everolimus-eluting stent in real-world patients with coronary artery disease (CAD).
It is a multi-centric, retrospective, non-randomized, single-arm study enrolling all the consecutive patients who underwent implantation with the Everoflex for CAD from April 2014 to March 2016. The primary end-point of this follow-up is to determine the incidence of major adverse cardiac events (MACE) at the end of 12-month. Stent thrombosis (ST), cardiac death, myocardial infarction (MI), target vessel revascularization (TVR) and target lesion revascularization (TLR) were adjudicated according to Academic Research Consortium (ARC). Demographic, clinical and procedural variables were assessed by descriptive statistics.
A total of 340 patients were intervened with 447 everolimus-eluting stents (1.3 ± 0.6 stents per patient). Out of total patients (58.8 ± 10.5 years), 77.9% were male and risk factors like diabetes and hypertension were observed in 31.2% and 35.3% patients, respectively. According to ACC/AHA classification, there were 34.4% type B lesions and 53.2% type C lesions, indicating a higher proportion of complexity involved. Moreover, more than half of the patients (57.9%) had multi-vessel disease and 15.4% had total occlusion. At the end of 12-month, follow-up was completed in all the patients enrolled in the study. The MACE and stent thrombosis at the end of 12-month was found to be 4.4% (1.8% cardiac death, 0.9% MI, 1.5% TLR and 1.8% TVR) and 0.9%, respectively. The cumulative event free-survival by Kaplan meier estimation was found to be 95.6%.
The lower rate of MACE and stent thrombosis depicts excellent safety and efficacy of the Everoflex everolimus-eluting stent at the end of 12-month in real-world patients with CAD.
CORONARY: Stents: Drug-Eluting