Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil.
JACC Cardiovasc Interv. 2009 May;2(5):422-7. doi: 10.1016/j.jcin.2009.02.009.
We sought to assess the safety and efficacy of the novel VESTAsync-eluting stent (MIV Therapeutics, Atlanta, Georgia) combining a stainless steel platform with a nanothin-microporous hydroxyapatite surface coating impregnated with a polymer-free low-dose of sirolimus (55 microg).
Durable polymers in first-generation drug-eluting stents (DES) have been linked to local inflammatory reaction leading to a positive vessel remodeling, late incomplete stent apposition, and in some cases, stent thrombosis. The removal of the polymer from the DES system could increase the safety profile of this novel technology.
A total of 15 patients with single de novo lesions in native coronary arteries with 3.0- to 3.5-mm diameter and <or=14-mm length were enrolled in this first-in-man study. Primary end point was in-stent late lumen loss (LL) at 4 and 9 months.
Baseline characteristics included mean age of 63 years and 33% of diabetics. Reference vessel diameter and lesion length were 2.7 +/- 0.3 mm and 10 +/- 2.0 mm, respectively. Procedure success was obtained in all cases. Lifelong aspirin and 5-month clopidogrel treatment were prescribed to all patients. At 4 months, in-stent LL and percentage of neointimal hyperplasia were 0.3 +/- 0.25 mm and 2.6 +/- 2.2%, respectively, with a nonsignificant increase at 9 months (0.36 +/- 0.23 mm and 4.0 +/- 2.2%, respectively). Serial intravascular ultrasound did not show late incomplete stent apposition. There were no major adverse cardiac events within 1 year of follow-up.
The novel VESTAsync-eluting stent was effective in reducing LL and neointimal hyperplasia at 4 and 9 months, with no evidence of late catch-up by quantitative coronary angiography or intravascular ultrasound.
我们旨在评估新型 VESTAsync 洗脱支架（MIV 治疗公司，佐治亚州亚特兰大）的安全性和疗效，该支架结合了不锈钢平台和纳米微孔羟基磷灰石表面涂层，该涂层浸渍有不含聚合物的低剂量西罗莫司（55 微克）。
第一代药物洗脱支架（DES）中的耐用聚合物与局部炎症反应有关，导致正性血管重构、晚期支架贴壁不良，在某些情况下还会导致支架血栓形成。从 DES 系统中去除聚合物可以提高这种新型技术的安全性。
共有 15 名患者入组了这项首例人体研究，他们均患有单一的初发病变，位于原生冠状动脉内，病变血管直径为 3.0-3.5mm，长度小于或等于 14mm。主要终点是 4 个月和 9 个月时的支架内晚期管腔丢失（LL）。
基线特征包括平均年龄为 63 岁，33%的患者患有糖尿病。参考血管直径和病变长度分别为 2.7±0.3mm 和 10±2.0mm。所有病例均获得了手术成功。所有患者均终生服用阿司匹林和 5 个月的氯吡格雷治疗。4 个月时，支架内 LL 和新生内膜增生百分比分别为 0.3±0.25mm 和 2.6±2.2%，9 个月时无明显增加（分别为 0.36±0.23mm 和 4.0±2.2%）。连续血管内超声未显示晚期支架贴壁不良。在 1 年的随访期间，没有重大不良心脏事件发生。
新型 VESTAsync 洗脱支架可有效减少 4 个月和 9 个月时的 LL 和新生内膜增生，定量冠状动脉造影或血管内超声均未显示晚期追赶现象。
