One-Year Clinical Outcomes of Biodegradable Polymer-Coated Sirolimus-Eluting Coronary Stent System in Patients with Coronary Artery Disease

Abstract

Background: The biodegradable polymer-coated sirolimus-eluting coronary stent (SES) system for the treatment of coronary artery disease (CAD) has been implanted in a real-world patient population. Aim: The present study was designed to evaluate the safety and performance of Metafor™ sirolimuseluting coronary stent (SES) system in consecutive patients with CAD in a real-world patient population. Methods: All the consecutive 251 patients who underwent percutaneous coronary interventions with the use of Metafor sirolimus-eluting stents were included in this study. Patients were clinically/telephonically followed-up at one-year from August 2015 to August 2016. We observed and analyzed major adverse cardiac event (MACE) defined as the aggregate of cardiac death, myocardial infarction (MI), and any target lesion revascularization (TLR) at one-year. Also, stent thrombosis (ST) was observed at one-year patients follow-up. Results: We collected and analyzed the data for 251 patients. Out of 251 participants, 191 (76.1%) were males, 95 (37.8%) patients had diabetes, 117 (46.6%) had ST-segment-elevation myocardial infarction (STEMI), and 134 (53.4%) had hypertension. Mean patient age was 56.35 ± 11.23 years. A total of 295 lesions were treated, out of which 13.6% of the lesions were the long lesion of ≥40 mm. At one-year, MACE occurred in 4 (1.6%) of 251 patients, consisting of 2 (0.8%) cardiac deaths, 2 (0.8%) MI, and 0 (0%) TLR. Stent thrombosis was reported in one patient (0.4%). Conclusions: This retrospective data demonstrated excellent safety and performance of Metafor SES in a "real-world" consecutive CAD patient, indicating low rates of MACE and ST at one-year follow-up.

Twelve-months clinical outcomes of biodegradable polymer-coated sirolimus-eluting coronary stent in real-world patients: A single-center experience.

“…In this study, the incidence of MACE and ST was 1.6% and 0.4% at 12-month follow-up, respectively. 5 In the long term follow-up (3.6 ± 0.6 years) of Metafor SES in a real-world retrospective study by Rao et al reported a MACE rate of 1.6% (attributed by 2 incidences of TLR) in 127 patients (169 lesions). Low rate of MACE obtained on long term follow-up is noteworthy despite of complex patient population.…”

“…The safety and efficacy of the Metafor SES have been confirmed among all-comers populations of south India. 5 This retrospective, observational study was designed to evaluate the safety and performance of Metafor SES in real-world populations having a wide spectrum of coronary artery disease (CAD).…”