Lee Wei-Chieh, Wu Chiung-Jen, Chen Chien-Jen, Yang Cheng-Hsu, Hsueh Shu-Kai, Yip Hon-Kan, Hang Chi-Ling, Fang Chih-Yuan, Fang Hsiu-Yu
Division of Cardiology, Department of Internal Medicine, Kaohsiung Chang Gung Memorial Hospital, Chang Gung University College of Medicine, Kaohsiung, Taiwan.
Acta Cardiol Sin. 2017 Nov;33(6):614-623. doi: 10.6515/ACS20170714A.
Available data on the use of the Bioresorbable vascular scaffold (BVS) (Abbott Vascular, Santa Clara, CA) in real-world patients is limited, particularly in Asian populations. The aim of this study was to assess clinical outcomes of patients treated with a BVS in real-world practice in Taiwan.
This study focused on 156 patients with coronary artery disease and a total of 249 lesions who received BVS implantation from October 2012 to October 2015. The study's primary endpoint was major adverse cardiac event (MACE), such as a myocardial infarction (MI), target vessel revascularization (TVR), target lesion revascularization (TLR), definite or possible scaffold thrombosis, cardiovascular death, and all-cause mortality during the thirty-day follow-up period. The secondary endpoint was MACE during the one-year follow-up period. Additionally, the composite clinical secondary endpoint was target lesion failure (TLF), which was called device-oriented composite endpoint.
The average age of the patients was 60.34 ± 10.15 years, and 81.4% were male. The average of Syntax score was 12.42 ± 8.77 points. 44.2 % lesions were type B2 or C. At 31 days, one patient experienced a MACE (1/156) the composite of two TLF (2/249) with ST elevation MI, which was related to scaffold thrombosis. At one-year, 5.1 % (8/156) of the patients experienced a MACE and 3.6% (9/249) of the lesions experienced a TLF. There was no cardiovascular or all-cause mortality in the 30-day follow-up. The one-year cardiovascular and all-cause mortality rates were each 1.3%, respectively. Diabetes, ostial lesion, bifurcation lesion, and non-standard dual anti-platelet therapy (DAPT) were the strong associations of one-year TLF.
Even with difficult and complex lesions of patients in this study, acceptable outcomes were achieved with low definite or possible scaffold thrombosis rates after BVS implantation. And despite anatomical issues, it is important to complete standard DAPT.
关于生物可吸收血管支架（BVS，雅培血管，加利福尼亚州圣克拉拉）在真实世界患者中的应用数据有限，尤其是在亚洲人群中。本研究的目的是评估台湾地区真实世界中接受BVS治疗患者的临床结局。
本研究聚焦于2012年10月至2015年10月期间接受BVS植入的156例冠心病患者及共249处病变。研究的主要终点是主要不良心脏事件（MACE），如心肌梗死（MI）、靶血管血运重建（TVR）、靶病变血运重建（TLR）、明确或可能的支架血栓形成、心血管死亡以及30天随访期内的全因死亡率。次要终点是1年随访期内的MACE。此外，复合临床次要终点是靶病变失败（TLF），即器械导向复合终点。
患者的平均年龄为60.34±10.15岁，男性占81.4%。Syntax评分平均为12.42±8.77分。44.2%的病变为B2或C型。在31天时，1例患者发生MACE（1/156），2处病变出现复合TLF（2/249）并伴有ST段抬高型MI，这与支架血栓形成有关。在1年时，5.1%（8/156）的患者发生MACE，3.6%（9/249）的病变出现TLF。30天随访期内无心血管或全因死亡。1年时心血管和全因死亡率均为1.3%。糖尿病、开口病变、分叉病变和非标准双联抗血小板治疗（DAPT）是1年TLF的强相关因素。
即使本研究中的患者病变困难且复杂，但BVS植入后明确或可能的支架血栓形成率较低，取得了可接受的结局。尽管存在解剖学问题，但完成标准DAPT很重要。
