Sinan Umit Yasar, Serin Ebru, Keskin-Meric Bengisu, Arat-Ozkan Alev
Department of Cardiology, İstanbul University Cardiology Institute, 34096 Istanbul, Turkey.
Rev Cardiovasc Med. 2023 Feb 6;24(2):53. doi: 10.31083/j.rcm2402053. eCollection 2023 Feb.
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.
在接受经皮冠状动脉介入治疗（PCI）的患者中，药物洗脱支架（DES）是目前的标准治疗方法。支架设计和合金成分、药物洗脱聚合物涂层的生物相容性、抗增殖剂的特性和释放是影响DES性能的三个主要特征。Cre8（土耳其伊斯坦布尔的Alvimedica公司）是一种无聚合物的安普利霉素洗脱支架（PF - AES）。在本研究中，我们旨在调查Cre8 DES在日常心脏病学实践中的临床疗效和安全性。
对2015年12月至2016年期间因慢性冠状动脉综合征（CCS）或急性冠状动脉综合征（ACS）（包括不稳定型心绞痛（USAP）、伴或不伴ST段抬高的心肌梗死）而接受使用Cre8 DES的PCI治疗的患者进行回顾性分析。
在2015年12月至2016年期间，本回顾性分析纳入了在单一中心接受Cre8 DES治疗的664例患者的808个病变。研究组的平均年龄为60岁（33至93岁），主要为男性患者（79.4%）。中位随访时间为487天（最短：30天，最长：919天），所有患者中有三分之二表现为ACS。大多数患者的罪犯病变位于左前降支（LAD）（40.5%）和右冠状动脉（RCA）（25.9%）。手术成功率为97.3%。根据美国心脏病学会/美国心脏协会（ACC/AHA）冠状动脉病变分类，大多数病变为B1型（40.6%）。定义为靶病变失败（TLF）的器械导向主要终点在808个病变中的52个（6.4%）出现。主要安全终点为20例患者（3.0%）发生心源性死亡，2例患者（0.3%）发生靶血管心肌梗死。作为主要安全终点，29例患者（4.4%）发生靶血管血运重建（TVR）。多变量逻辑回归分析显示，糖尿病和射血分数是死亡率和器械导向主要终点的预测因素。
本试验揭示了Cre8支架在现实世界实践中的临床疗效和安全性。器械导向主要终点与先前的研究相似，这些研究本质上是随机、开放标签的，并显示了Cre8支架对最新一代DES的疗效和安全性。
