Washington University School of Medicine, St. Louis, Mo., USA.
J Vasc Surg. 2011 Jul;54(1):71-9. doi: 10.1016/j.jvs.2010.12.054. Epub 2011 Mar 31.
The Society for Vascular Surgery (SVS) Vascular Registry (VR) collects data on outcomes of carotid endarterectomy and carotid artery stenting (CAS). The purpose of this study was to evaluate the impact of open vs closed cell stent design on the in-hospital and 30-day outcome of CAS.
The VR collects provider-reported data on patients using a Web-based database. Data were analyzed both in-hospital and at 30 days postprocedure. The primary outcome is combined death/stroke/myocardial infarction (MI).
As of October 14, 2009, there were 4337 CAS with discharge data and 2397 with 30-day data. Open cell stents (OPEN) were used in 3451 patients (79.6%), and closed cell stents (CLOSED) were used in 866 patients (20.4%). Baseline demographics showed no differences in age, gender, race, and ethnicity. However, the OPEN group had more patients with atherosclerosis (74.5% vs 67.4%; P = .0003) as the etiology of carotid artery disease. The OPEN group also had a higher prevalence of preprocedural stroke (25.8% vs 21.4%; P = .0079), chronic obstructive pulmonary disease (COPD; 21.0% vs 17.6%; P = .0277), cardiac arrhythmia (14.7% vs 11.4%; P = .0108), valvular heart disease (7.4% vs 3.7%; P < .0001), peripheral vascular disease (PVD; 40.0% vs 35.3%; P = .0109), and smoking history (59.0% vs 54.1%; P = .0085). There are no statistically significant differences in the in-hospital or 30-day outcomes between the OPEN and CLOSED patients. Further subgroup analyses demonstrated symptomatic patients had a higher event rate than the asymptomatic cohort in both the OPEN and CLOSED groups. Among symptomatic patients, the OPEN patients had a lower (0.43% vs 1.41%; P = .0349) rate of in-hospital mortality with no difference in stroke or transient ischemic attack (TIA). There were no differences in 30-day event rates. In asymptomatic patients, there were also no statistically significant differences between the OPEN and CLOSED groups. After risk adjustment, there remained no statistically significant differences between groups of the primary endpoint (death/stroke/MI) during in-hospital or 30 days.
In-hospital and 30-day outcomes after CAS were not significantly influenced by stent cell design. Symptomatic patients had higher adverse event rates compared to the asymptomatic cohort. As there is no current evidence of differential outcome between the use of open and closed cell stents, physicians should continue to use approved stent platforms based on criteria other than stent cell design.
血管外科学会(SVS)血管登记处(VR)收集颈动脉内膜切除术和颈动脉支架置入术(CAS)的结果数据。本研究的目的是评估开放细胞与封闭细胞支架设计对 CAS 住院和 30 天结果的影响。
VR 使用基于网络的数据库收集有关患者的提供者报告数据。数据在住院期间和术后 30 天进行分析。主要结局是联合死亡/中风/心肌梗死(MI)。
截至 2009 年 10 月 14 日,有 4337 例 CAS 出院数据,2397 例有 30 天数据。开放细胞支架(OPEN)用于 3451 例患者(79.6%),封闭细胞支架(CLOSED)用于 866 例患者(20.4%)。基线人口统计学数据显示,年龄、性别、种族和民族无差异。然而,OPEN 组有更多的动脉粥样硬化患者(74.5%比 67.4%;P=0.0003)作为颈动脉疾病的病因。OPEN 组术前中风的发生率也更高(25.8%比 21.4%;P=0.0079)、慢性阻塞性肺疾病(COPD;21.0%比 17.6%;P=0.0277)、心律失常(14.7%比 11.4%;P=0.0108)、瓣膜性心脏病(7.4%比 3.7%;P<0.0001)、外周血管疾病(PVD;40.0%比 35.3%;P=0.0109)和吸烟史(59.0%比 54.1%;P=0.0085)。OPEN 和 CLOSED 患者的住院或 30 天结果无统计学差异。进一步的亚组分析表明,在 OPEN 和 CLOSED 两组中,有症状患者的事件发生率均高于无症状患者。在有症状患者中,OPEN 患者的住院死亡率较低(0.43%比 1.41%;P=0.0349),中风或短暂性脑缺血发作(TIA)无差异。30 天事件发生率无差异。在无症状患者中,OPEN 和 CLOSED 组之间也无统计学差异。在风险调整后,住院或 30 天内主要终点(死亡/中风/MI)两组之间仍无统计学差异。
CAS 后的住院和 30 天结果不受支架细胞设计的显著影响。有症状患者的不良事件发生率高于无症状患者。由于目前没有开放细胞和封闭细胞支架使用效果差异的证据,医生应根据支架细胞设计以外的标准继续使用批准的支架平台。