Vascular Medicine Section and Vascular Center, Massachusetts General Hospital, Boston (I.W., K.R.)
Vanderbilt University, Nashville, TN (J.A.B.).
Circulation. 2018 Jan 2;137(1):49-56. doi: 10.1161/CIRCULATIONAHA.117.030030. Epub 2017 Oct 5.
The impact of carotid artery stent fractures on the incidence of adverse clinical events remains unclear. The objective of this study is to report the stent fracture rate and its association with in-stent restenosis and adverse outcomes in the ACT-1 trial (Carotid Angioplasty and Stenting Versus Endarterectomy in Asymptomatic Subjects Who Are at Standard Risk for Carotid Endarterectomy With Significant Extracranial Carotid Stenotic Disease).
ACT-1 is a prospective multicenter trial of patients who have standard surgical risk with severe asymptomatic carotid artery stenosis randomly assigned to carotid artery stenting or carotid endarterectomy (Abbott Vascular). The primary end point was a composite of death, stroke, or myocardial infarction during the 30 days after the procedure or ipsilateral stroke during the 365 days after the procedure. After 771 patients were enrolled, successively randomly assigned patients were required to undergo annual radiographic (x-ray) analysis for stent fracture. Images were independently adjudicated by a core laboratory.
Of 1021 patients treated with carotid artery stenting during a mean follow-up of 3.1±1.6 years, 939 had at least 1 x-ray during the follow-up period. Stent fracture was reported in 51 (5.4%) patients. With a maximum follow-up period of 5 years, adverse clinical outcomes occurred in 39 patients with at least 1 x-ray during the follow-up. Of 826 (80.9%) subjects who underwent both duplex ultrasound and x-ray, 822 (99.5%) were interpretable. There was no association between stent fracture and the primary end point (=0.86) or with restenosis (=0.53).
In this large, independently adjudicated, multicenter study, the stent fracture rate was low and not associated with major adverse clinical events or in-stent restenosis.
URL: https://www.clinicaltrials.gov. Unique identifier: NCT00106938.
颈动脉支架断裂对不良临床事件发生率的影响尚不清楚。本研究的目的是报告 ACT-1 试验（无症状且标准颈动脉内膜切除术风险患者的颈动脉血管成形术和支架置入与内膜切除术比较：伴明显颅外颈动脉狭窄的高危患者）中支架断裂的发生率及其与支架内再狭窄和不良结局的关系。
ACT-1 是一项前瞻性多中心试验，纳入了标准手术风险且伴有严重无症状颈动脉狭窄的患者，这些患者被随机分配接受颈动脉支架置入或颈动脉内膜切除术（雅培血管）治疗。主要终点是术后 30 天内死亡、卒中和心肌梗死的复合终点，或术后 365 天内同侧卒中和心肌梗死的复合终点。在纳入了 771 例患者后，连续随机分配的患者需要每年进行支架断裂的影像学（X 线）分析。图像由核心实验室进行独立裁决。
在平均 3.1±1.6 年的随访中，1021 例接受颈动脉支架置入治疗的患者中，939 例在随访期间至少进行了 1 次 X 线检查。51 例（5.4%）患者报告了支架断裂。在最长 5 年的随访期间，在随访期间至少进行了 1 次 X 线检查的 39 例患者中发生了不良临床结局。在 826 例（80.9%）同时进行了双功能超声和 X 线检查的患者中，822 例（99.5%）结果可解释。支架断裂与主要终点（=0.86）或支架内再狭窄（=0.53）无相关性。
在这项大型、独立裁决、多中心研究中，支架断裂的发生率较低，与主要不良临床事件或支架内再狭窄无关。
网址：https://www.clinicaltrials.gov。唯一标识符：NCT00106938。
