Sunshine Heart Institute, Secunderabad, India.
Chalmeda Anandrao Institute of Medical Sciences, Karimnagar, India.
Anatol J Cardiol. 2022 Aug;26(8):619-628. doi: 10.5152/AnatolJCardiol.2022.844.
Tetrilimus (Sahajanand Medical Technologies Limited, Surat, India) is a biodegradable polymer-coated everolimus-eluting stent with cobalt-chromium stent platform and ultra-thin (60 µm) strut thickness. We aimed to report 1-year safety and clinical performance of Tetrilimus everolimus-eluting stent in patients with coronary artery disease in "real-world" clinical practice.
The PERFORMance of biodegradable polymer-coated ultra-thin EVERolimuseluting stents was an observational, multicenter, single-arm, and investigator-initiated retrospective registry. All "real-world" patients who had received Tetrilimus everolimuseluting stent between July-2015 and October-2016 at four study centers were analyzed. The data were collected retrospectively either by extraction from existing databases in consecutive fashion where index and follow-up data existed or the follow-up was obtained by telephonic contact. Primary endpoint was 1-year incidence of target lesion failure, which was defined as a composite endpoint of cardiac death, myocardial infarction, and target lesion revascularization by percutaneous or surgical methods. The Academic Research Consortium-defined stent thrombosis was assessed as additional safety endpoint.
During the study period, 815 Tetrilimus everolimus-eluting stents (1.4 ± 0.5 stent/ patient) were implanted to treat 735 coronary lesions (1.1 ± 0.3 stent/lesion) in 594 patients (mean age: 55.6 ± 12.1 years). The cumulative incidence of target lesion failure at 1-year follow-up was 3.7%, which included 9 (1.5%) cardiac deaths, 8 (1.4%) myocardial infarctions, and 5 (0.8%) target lesion revascularizations. There were 5 (0.8%) cases of probable stent thrombosis and 4 (0.7%) cases of possible stent thrombosis at 1-year follow-up.
Low incidences of target lesion failure and stent thrombosis at 1-year followup indicates that biodegradable polymer-coated ultra-thin Tetrilimus everolimus-eluting stents may have encouraging safety and efficacy in unselected real-world patients with coronary artery disease, including those with high-risk characteristics and complex lesions.
特替利姆（印度苏拉特 Sahajanand Medical Technologies 有限公司）是一种可生物降解聚合物涂层的依维莫司洗脱支架，具有钴铬支架平台和超薄（60µm）的支架梁厚度。我们旨在报告特替利姆依维莫司洗脱支架在“真实世界”临床实践中治疗冠状动脉疾病患者的 1 年安全性和临床疗效。
PERFORMance 研究是一项观察性、多中心、单臂、研究者发起的回顾性注册研究。对 2015 年 7 月至 2016 年 10 月在四个研究中心接受特替利姆依维莫司洗脱支架治疗的所有“真实世界”患者进行了分析。通过连续提取现有数据库或通过电话联系获取索引期和随访期数据，对数据进行回顾性收集。主要终点为 1 年时靶病变失败的发生率，定义为心脏死亡、心肌梗死和经皮或手术方法靶病变血运重建的复合终点。采用学术研究联合会（Academic Research Consortium，ARC）定义的支架血栓形成作为安全性的附加终点。
在研究期间，共植入 815 枚特替利姆依维莫司洗脱支架（1.4±0.5 枚/患者），治疗 735 例冠状动脉病变（1.1±0.3 枚/病变），共 594 例患者（平均年龄：55.6±12.1 岁）。1 年随访时靶病变失败的累积发生率为 3.7%，包括 9 例（1.5%）心脏死亡、8 例（1.4%）心肌梗死和 5 例（0.8%）靶病变血运重建。1 年随访时，有 5 例（0.8%）可能为支架血栓形成，4 例（0.7%）为确定为支架血栓形成。
1 年随访时靶病变失败和支架血栓形成发生率较低，表明可生物降解聚合物涂层的超薄特替利姆依维莫司洗脱支架在未选择的冠状动脉疾病患者中可能具有良好的安全性和疗效，包括具有高危特征和复杂病变的患者。
