San Raffaele Scientific Institute, Milan, Italy.
Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Int J Cardiol. 2019 May 15;283:67-72. doi: 10.1016/j.ijcard.2019.01.053. Epub 2019 Jan 21.
The COMBO stent (OrbusNeich Medical, Ft. Lauderdale, Florida) is a new-generation bio-engineered drug eluting stent, combining an abluminal coating of a bioabsorbable polymer matrix for sustained release of sirolimus and luminal anti-CD34 coating for endothelial progenitor cell capture and rapid endothelialization.
The Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) registry was a prospective post-marketing study conducted from June 2014-May 2017 across 60 centers globally. Patients were eligible if COMBO stent implantation was attempted, and they received dual antiplatelet therapy (DAPT) per local guidelines. Follow-up was conducted by trained research staff at 1, 6 and 12 months by phone or clinic visit to capture clinical events and DAPT cessation events. The primary endpoint was 1-year target lesion failure (TLF), composite of cardiac death, non-fatal myocardial infarction not clearly attributable to a non-target vessel, or ischemia-driven target lesion revascularization.
A total of 2614 patients were enrolled over the study period with 96.7% completion of 1-year follow-up. The mean age of enrolled patients was 62.9 ± 11.2 years and 23.0% were female. Diabetes mellitus was present at baseline in 33.5%. A total of 56.1% patients underwent PCI for acute coronary syndrome (ACS). The 1-year primary endpoint of TLF occurred in 3.4% patients (n = 88). Definite stent thrombosis occurred in 0.5% patients (n = 12).
The MASCOT post marketing registry provides comprehensive safety and efficacy outcomes following contemporary PCI using the novel COMBO stent in an all-comer population. This platform is associated with low rates of 1-year TLF and ST. CLINICALTRIALS.
NCT02183454.
COMBO 支架（OrbusNeich Medical，佛罗里达州劳德代尔堡）是一种新一代的生物工程药物洗脱支架，其外表面涂有生物可吸收聚合物基质，用于持续释放西罗莫司，内表面涂有抗-CD34 涂层，用于捕获内皮祖细胞并快速内皮化。
多国无涂层西罗莫司涂层生物工程支架（MASCOT）注册研究是一项于 2014 年 6 月至 2017 年 5 月在全球 60 个中心进行的前瞻性上市后研究。如果尝试植入 COMBO 支架，且患者根据当地指南接受双联抗血小板治疗（DAPT），则符合入组条件。通过电话或临床访视由经过培训的研究人员在 1、6 和 12 个月时进行随访，以收集临床事件和 DAPT 停药事件。主要终点是 1 年靶病变失败（TLF），复合终点为心脏死亡、不能明确归因于非靶病变血管的非致死性心肌梗死或缺血驱动的靶病变血运重建。
在研究期间共纳入了 2614 例患者，1 年随访的完成率为 96.7%。入组患者的平均年龄为 62.9±11.2 岁，23.0%为女性。基线时有 33.5%的患者患有糖尿病。共有 56.1%的患者因急性冠状动脉综合征（ACS）而行 PCI。3.4%（n=88）的患者在 1 年内发生了主要终点 TLF。0.5%（n=12）的患者发生了明确的支架血栓形成。
MASCOT 上市后注册研究在全人群中提供了使用新型 COMBO 支架进行当代 PCI 后的全面安全性和疗效结果。该平台与 1 年 TLF 和 ST 的发生率低相关。CLINICALTRIALS.GOV 标识符：NCT02183454。
