Remkes W S, Hermanides R S, Kennedy M W, Fabris E, Kaplan E, Ottervanger J P, van 't Hof A W J, Kedhi E
Isala Hartcentrum, Zwolle, The Netherlands.
Neth Heart J. 2017 Nov;25(11):611-617. doi: 10.1007/s12471-017-1038-4.
Recent evidence has raised concerns regarding the safety of the everolimus-eluting bioresorbable vascular scaffold (E-BVS) (Absorb, Abbott Vascular, Santa Clara, CA, USA). Following these data, the use of this device has diminished in the Netherlands; however, daily practice data are limited. Therefore we studied the incidence of safety and efficacy outcomes with this device in daily clinical practice in a single large tertiary centre in the Netherlands.
All E‑BVS treated patients were included in this analysis. The primary endpoint was target lesion failure (TLF), a composite of cardiac death, target vessel non-fatal myocardial infarction (TV-MI) and clinically-driven target lesion revascularisation (TLR). The secondary endpoint was the incidence of definite scaffold thrombosis.
Between October 2013 and January 2017, 105 patients were treated with 147 E‑BVS. This population contained 42 (40%) patients with diabetes mellitus and 43 (40.9%) undergoing treatment for acute coronary syndrome, and thus represents a high-risk patient cohort. Mean follow-up was 19.8 months. Intravascular imaging guidance during scaffold implantation was used in 64/105 (43.5%) patients. The primary endpoint (TLF) occurred in 3 (2.9%) patients. All-cause mortality and cardiac mortality occurred in 2 (2%) and 0 (0%) patients respectively. TV-MI occurred in 2 patients (1.9%): both were periprocedural and not related to the BVS implantation. TLR occurred in 1 patient (1.0%) during follow-up. No definite scaffold thrombosis occurred during follow-up.
This single-centre study examining the real-world experience of E‑BVS implantation in a high-risk population shows excellent procedural safety and long-term clinical outcomes.
最近的证据引发了对依维莫司洗脱生物可吸收血管支架（E-BVS，美国加利福尼亚州圣克拉拉市雅培血管公司的Absorb）安全性的担忧。基于这些数据，该装置在荷兰的使用量有所减少；然而，日常实践数据有限。因此，我们在荷兰一家大型三级中心的日常临床实践中研究了该装置安全性和有效性结果的发生率。
所有接受E-BVS治疗的患者均纳入本分析。主要终点是靶病变失败（TLF），它是心脏性死亡、靶血管非致死性心肌梗死（TV-MI）和临床驱动的靶病变血运重建（TLR）的复合终点。次要终点是明确的支架血栓形成发生率。
2013年10月至2017年1月期间，105例患者接受了147枚E-BVS治疗。该人群中有42例（40%）糖尿病患者和43例（40.9%）接受急性冠状动脉综合征治疗的患者，因此代表了一个高危患者队列。平均随访时间为19.8个月。64/105例（43.5%）患者在支架植入过程中使用了血管内成像引导。主要终点（TLF）发生在3例（2.9%）患者中。全因死亡率和心脏死亡率分别发生在2例（2%）和0例（0%）患者中。TV-MI发生在2例患者（1.9%）中：均发生在围手术期，与BVS植入无关。随访期间1例患者（1.0%）发生TLR。随访期间未发生明确的支架血栓形成。
这项单中心研究考察了在高危人群中植入E-BVS的真实世界经验，显示出了出色的手术安全性和长期临床结果。
