Lin Peter H, Zhou Wei, Guerrero Marlon A, McCoy Sally A, Felkai Deborah, Kougias Panos, El Sayed Hosam F
Division of Vascualr and Endovascular Therapy, Micheal E. DeBakey Department of Surgery, Baylor College of Medicine and the Methodist Hospital, Houston, TX 77030, USA.
Vascular. 2006 Sep-Oct;14(5):237-44. doi: 10.2310/6670.2006.00054.
Emerging data have supported the clinical efficacy of carotid artery stenting (CAS) in stroke prevention in high-risk surgical patients. This study was performed to evaluate the midterm clinical outcome of CAS using the Carotid Wallstent and FilterWire distal protection (both Boston Scientific, Natick, MA) at an academic institution. Risk factors for in-stent restenosis (ISR) were also analyzed. Clinical variables and treatment outcome of high-risk patients who underwent Carotid Wallstent placement with FilterWire EX/EZ neuroprotection were analyzed during a recent 54-month period. Three hundred eighty CAS procedures were performed in 354 patients. Technical success was achieved in 372 cases (98%), and symptomatic lesions existed in 85 (24%) patients. No patient experienced periprocedural mortality or neuroprotective device-related complication. The 30-day stroke and death rate was 2.7%, and the overall complication rate was 6.9%. The overall major or fatal stroke rates in symptomatic and asymptomatic patients were 4.6% and 1.3%, respectively (not significant). The overall stroke and death rates between the symptomatic and asymptomatic groups were 5.8% and 2.4%, respectively (not significant). The median follow-up period was 29 months (range 1-53 months). With Kaplan-Meier analysis, the rates of freedom from 60% or greater ISR after CAS procedures at 12, 24, 36, and 48 months were 97%, 94%, 92%, and 90%, respectively. The rates of freedom from all fatal and nonfatal strokes at 12, 24, 36, and 48 months were 97%, 91%, 89%, and 85%, respectively. Multivariable analysis of significant univariate predictors identified that postendarterectomy stenosis (odds ratio [OR] 3.98, p = .02) and multiple stent placement (OR 3.68, p = .03) were independent predictors of ISR. Our study yielded favorable short-term and midterm clinical results using Carotid Wallstent with FilterWire neuroprotection. Late follow-up results showed low rates of fatal and nonfatal stroke and favorable ISR rates compared with other carotid stent trials. Postendarterectomy and multiple stent placement were associated with subsequent ISR.
新出现的数据支持了颈动脉支架置入术(CAS)在高危手术患者预防卒中方面的临床疗效。本研究旨在评估在一所学术机构使用颈动脉Wallstent支架和FilterWire远端保护装置(均为波士顿科学公司,马萨诸塞州纳蒂克)进行CAS的中期临床结果。还分析了支架内再狭窄(ISR)的危险因素。分析了在最近54个月期间接受带FilterWire EX/EZ神经保护装置的颈动脉Wallstent支架置入术的高危患者的临床变量和治疗结果。对354例患者进行了380例CAS手术。372例(98%)手术技术成功,85例(24%)患者存在有症状病变。无患者发生围手术期死亡或神经保护装置相关并发症。30天卒中及死亡率为2.7%,总体并发症发生率为6.9%。有症状和无症状患者的总体严重或致命卒中发生率分别为4.6%和1.3%(无显著性差异)。有症状组和无症状组的总体卒中和死亡率分别为5.8%和2.4%(无显著性差异)。中位随访期为29个月(范围1 - 53个月)。采用Kaplan-Meier分析,CAS术后12、24、36和48个月时,ISR≥60%的无事件发生率分别为97%、94%、92%和90%。12、24、36和48个月时所有致命和非致命卒中的无事件发生率分别为97%、91%、89%和85%。对显著单因素预测指标的多变量分析确定,动脉内膜切除术后狭窄(比值比[OR] 3.98,p = 0.02)和多个支架置入(OR 3.68,p = 0.03)是ISR的独立预测因素。我们的研究使用带FilterWire神经保护装置的颈动脉Wallstent支架取得了良好的短期和中期临床结果。与其他颈动脉支架试验相比,后期随访结果显示致命和非致命卒中发生率较低,ISR发生率良好。动脉内膜切除术后和多个支架置入与随后的ISR相关。