Cre8 Drug Eluting Stent Performance in Daily Cardiology Practice

In patients undergoing percutaneous coronary intervention (PCI), drug eluting stents (DES) are currently the standard of care. Stent design and alloy composition, biocompatibility of the drug-eluting polymer coating, the antiproliferative agent properties and release are the three main characteristics that affects DES performance. Cre8 (Alvimedica, Istanbul, Turkey) is a polymer-free amphilimus-eluting stents (PF-AES). In this study, we aimed to investigate the clinical efficacy and safety of Cre8 DES in daily cardiology practice.

Patients presenting with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) including unstable angina pectoris (USAP), myocardial infarction with and without ST-segment elevation and treated with PCI using Cre8 DES between December 2015 and 2016 were retrospectively analyzed in this study.

Between December 2015 and 2016, 808 lesions of 664 patients treated with Cre8 DES in a single center were included in this retrospective analysis. The mean age of study group was 60 years (between 33 and 93 years) and were predominantly consisting of male patients (79.4%). The median follow-up duration was 487 days (min: 30 days, max: 919 days) and two-thirds of all patients presented with ACS. The culprit lesion was on left anterior descending artery (LAD) (40.5%) and right coronary artery (RCA) (25.9%) in most of the patients. The procedural success rate was 97.3%. Most of the lesions were type B1 (40.6%) according to American College of Cardiology/American Heart Association (ACC/AHA) coronary lesion classification. The device oriented primary end-point defined as target lesion failure (TLF) occurred in 52 (6.4%) of 808 lesions. The primary safety end-point was cardiac death in 20 patients (3.0%) and target vessel myocardial infarction in 2 patients (0.3%). Target vessel revascularization (TVR) occurred in 29 patients (4.4%) as primary safety endpoint. Multivariable logistic regression analysis revealed diabetes mellitus and ejection fraction as the predictors of mortality and device oriented primary end-point.

This trial revealed clinical efficacy and safety of Cre8 stents in real world practice. Device oriented primary end points were similar with previous studies which are randomized, open label in nature and showed the efficacy and safety of Cre8 stent towards latest generation DES.