Interventional Cardiology Unit, San Raffaele Scientific Institute, Milan, Italy.
J Endovasc Ther. 2010 Jun;17(3):298-307. doi: 10.1583/09-2997.1.
To evaluate clinical outcomes in patients undergoing carotid artery stenting (CAS) with routine use of a cerebral embolic protection device (EPD).
A retrospective cohort analysis was conducted of 490 consecutive patients (365 men; mean age 70.7+/-8.5 years) who underwent CAS with EPD between January 1999 and December 2007 at 2 institutions with large referral practices. There were 163 symptomatic patients with stenosis >or=50% and 327 asymptomatic patients with >or=80% diameter stenosis treated in 536 CAS procedures. Nearly a quarter (116, 23.7%) of the cohort had diabetes. High-risk surgical features were present in 141 (28.8%): 73 (14.9%) aged >or=80 years, 25 (5.1%) with significant heart disease, 23 (4.6%) with postsurgical restenosis, and 16 (3.2%) with contralateral carotid occlusion. An EPD was successfully placed in 512 (95.5%) patients.
The incidence of any stroke within 30 days was 3.3% (16/490), of which the majority (13, 2.6%) were ipsilateral [5 (1.0%) major and 8 (1.6%) minor]. The incidence of major adverse events (MAE), i.e., any stroke, death or myocardial infarction, within 30 days was 3.7% (18/490); the incidence of 30-day any stroke/death was 3.7% (18/490), while the cumulative incidence of any stroke/death at 1 year was 6.1% (30/490). In symptomatic patients, the 30-day MAE rate was 6.7% (11/163) versus 2.1% (7/237) in the asymptomatic group (p = 0.02). A subgroup analysis based on surgical risk showed that the 30-day MAE rate was similar between high-risk and non-high-risk patients [4.9% (7/144) versus 3.2% (11/346); p = 0.5].
In this large real-world cohort, CAS with routine use of EPDs was technically feasible, clinically safe, and associated with a low rate of periprocedural and 1-year events; results were similar irrespective of surgical risk.
评估在常规使用脑保护装置（EPD）的情况下行颈动脉支架置入术（CAS）患者的临床结局。
对 1999 年 1 月至 2007 年 12 月在两家具有大型转诊业务的机构中接受 EPD 辅助 CAS 治疗的 490 例连续患者（365 例男性；平均年龄 70.7±8.5 岁）进行回顾性队列分析。163 例症状性患者狭窄程度>50%，327 例无症状患者狭窄程度>80%，共进行 536 例 CAS 手术。该队列中有近四分之一（116 例，23.7%）患有糖尿病。141 例患者具有高危手术特征（28.8%）：73 例（14.9%）年龄>80 岁，25 例（5.1%）患有严重心脏病，23 例（4.6%）为术后再狭窄，16 例（3.2%）为对侧颈动脉闭塞。512 例（95.5%）患者成功放置了 EPD。
30 天内任何卒中的发生率为 3.3%（16/490），其中大多数（13 例，2.6%）为同侧[5 例（1.0%）为主要卒中，8 例（1.6%）为次要卒中]。30 天内主要不良事件（MAE），即任何卒中和死亡或心肌梗死的发生率为 3.7%（18/490）；30 天内任何卒中和死亡的发生率为 3.7%（18/490），而 1 年时任何卒中和死亡的累积发生率为 6.1%（30/490）。在有症状的患者中，30 天 MAE 发生率为 6.7%（11/163），而无症状患者为 2.1%（7/237）（p=0.02）。基于手术风险的亚组分析显示，高危患者与非高危患者的 30 天 MAE 发生率相似[4.9%（7/144）与 3.2%（11/346）；p=0.5]。
在这项大型真实世界队列研究中，常规使用 EPD 的 CAS 技术上是可行的，临床上是安全的，围手术期和 1 年事件发生率较低；结果与手术风险无关。
