Northern Michigan Regional Hospital Heart and Vascular Institute, Petoskey, Michigan, USA.
Catheter Cardiovasc Interv. 2012 Oct 1;80(4):546-53. doi: 10.1002/ccd.23397. Epub 2012 Jan 12.
The SPIRIT Small Vessel (SV) was designed to evaluate the safety and effectiveness of the 2.25-mm XIENCE V everolimus eluting coronary stent system (EECSS), known as the XIENCE nano EECSS, in subjects with SVs and ischemic heart disease.
The core sizes of XIENCE V EECSS are associated with low rates of restenosis and thrombosis in the general population, but the XIENCE nano EECSS has not been tested in the United States.
This prospective, single-arm, open-label study was conducted at 33 centers and in 150 patients in the United States. The primary endpoint was the target lesion failure (TLF) rate at 1 year, required to meet the prespecified performance goal (PG) of 20.4%, derived from historical data.
The mean patient age was 63 years, 38% were women, 39.2% were diabetic, 49.3% had multivessel disease, and the reference vessel diameter was 2.13 ± 0.23 mm. The 1-year TLF rate was 8.1% in with an upper limit of the one-sided 95% confidence interval of 13.0%, which met the PG of 20.4% (P < 0.0001). At 1 year, the rate of cardiac death was 1.5%, the target vessel myocardial infarction rate was 1.5%, and clinically indicated target lesion revascularization rate was 5.1%. The 8-month angiographic in-stent late loss was 0.2 ± 0.4 mm, respectively. The 1-year academic research consortium defined definite/probable stent thrombosis rate was 1.5%.
Based on the 1-year clinical and 8-month angiographic SPIRIT SV data, the XIENCE nano EECSS is considered safe and effective in the treatment of SVs.
SPIRIT 小血管（SV）研究旨在评估 2.25 毫米 XIENCE V 依维莫司洗脱冠状动脉支架系统（EECSS），即 XIENCE 纳米 EECSS，在 SV 和缺血性心脏病患者中的安全性和有效性。
XIENCE V EECSS 的核心尺寸与一般人群中的再狭窄和血栓形成率较低相关，但 XIENCE 纳米 EECSS 尚未在美国进行过测试。
这是一项在美国 33 个中心和 150 名患者中进行的前瞻性、单臂、开放标签研究。主要终点是 1 年时的靶病变失败（TLF）率，需要满足源自历史数据的 20.4%预设性能目标（PG）。
患者平均年龄为 63 岁，38%为女性，39.2%为糖尿病患者，49.3%患有多支血管疾病，参考血管直径为 2.13 ± 0.23 毫米。1 年 TLF 率为 8.1%，单侧 95%置信区间上限为 13.0%，达到 20.4%的 PG（P<0.0001）。1 年时，心脏死亡率为 1.5%，靶血管心肌梗死率为 1.5%，临床指示的靶病变血运重建率为 5.1%。8 个月时的支架内晚期管腔丢失分别为 0.2 ± 0.4 毫米。1 年时学术研究联合会定义的明确/可能的支架血栓形成率为 1.5%。
根据 1 年的临床和 8 个月的血管造影 SPIRIT SV 数据，XIENCE 纳米 EECSS 被认为在治疗 SV 方面是安全有效的。
