Meredith Ian T, Worthley Stephen, Whitbourn Robert, Walters Darren, Popma Jeff, Cutlip Don, Fitzgerald Peter
Monash Medical Center and Monash University, Melbourne, Australia.
EuroIntervention. 2007 May;3(1):50-3.
To demonstrate the safety, performance and efficacy of the Endeavor Resolute stent in the treatment of patients with multiple-vessel as well as single-vessel coronary artery disease but where only one lesion per patient was treated.
130 patients were treated with the Endeavor Resolute stent. Of these patients, 30 consented to a 4 month follow-up evaluation by quantitative coronary angiography (QCA) and intravascular ultrasound (IVUS) measurements, and 100 consented to a 9 month follow-up evaluation by QCA. Only lesions with diameter stenoses > 50% and with lengths > 14 mm and < 27 mm in vessels with reference diameters > 2.5 mm to < 3.5 mm were included. The device success rate as 99.2%, and the procedure success rate was 96.2%. The mean lesion length was 15.56+/-6.27 mm. The overall 30 day incidence of major adverse cardiac events (MACE) was 3.3%, which consisted entirely of 5 cases of peri-procedural non-Q-wave MI. The QCA and IVUS results at 4 months for the 30 patient subgroup showed in-stent late lumen loss was 0.12+/-0.26 mm, and in segment late lumen loss was 0.05+/-0.20 mm.
The 4 month results in this subset of Endeavor Resolute patients demonstrated excellent procedural and device success when deployed in lesions up to 27 mm of length. The Endeavor Resolute stent, in this subset, was associated with a low in-stent late lumen loss and a minimal amount of neointimal hyperplastic in-growth.
证明安进公司的Endeavor Resolute支架在治疗多支血管以及单支血管冠状动脉疾病患者（但每位患者仅治疗一处病变）时的安全性、性能和疗效。
130例患者接受了Endeavor Resolute支架治疗。其中，30例患者同意通过定量冠状动脉造影（QCA）和血管内超声（IVUS）测量进行4个月的随访评估，100例患者同意通过QCA进行9个月的随访评估。仅纳入参考直径在2.5 mm至3.5 mm之间、直径狭窄>50%且长度>14 mm和<27 mm的病变。器械成功率为99.2%，手术成功率为96.2%。平均病变长度为15.56±6.27 mm。30天主要不良心脏事件（MACE）的总发生率为3.3%，全部由5例围手术期非Q波心肌梗死组成。30例患者亚组在4个月时的QCA和IVUS结果显示，支架内晚期管腔丢失为0.12±0.26 mm，节段内晚期管腔丢失为0.05±0.20 mm。
在这组Endeavor Resolute患者中，4个月的结果表明，当应用于长度达27 mm的病变时，手术和器械成功率极佳。在这组患者中，Endeavor Resolute支架与较低的支架内晚期管腔丢失以及最小量的新生内膜增生性向内生长相关。
