Division of Vascular Therapy, Hawaii Permanente Medical Group and Kaiser Foundation Hospital, Honolulu, Hawaii.
Jacobs School of Medicine and Biomedical Sciences, University of Buffalo, Buffalo, New York.
JACC Cardiovasc Interv. 2018 Dec 10;11(23):2396-2404. doi: 10.1016/j.jcin.2018.07.040.
The primary purpose of this study was the composite of major adverse events through 30 days post-index procedure or ipsilateral stroke from 30 days to 1 year (365 days). Presented here is the composite of death, stroke, and myocardial infarction (MI) through 30 days.
Rates of minor stroke have been higher with carotid artery stenting (CAS) compared with carotid endarterectomy (CEA). The study hypothesized that a stent with mesh covering may improve plaque stabilization during CAS, reduce plaque protrusion, and lead to reduced stroke rates.
The SCAFFOLD trial, a prospective, multicenter, single-arm clinical trial evaluating the GORE carotid stent (GCS), enrolled patients at increased risk for adverse events from CEA with severe carotid artery stenosis (defined as symptomatic ≥50% or asymptomatic ≥80%). The SCAFFOLD trial screening committee was implemented to determine adherence to the study protocol. Patients were evaluated for the primary endpoint, the composite of death, stroke, and MI through 30 days.
A total of 312 patients were enrolled, treated, and reviewed by the SCAFFOLD trial screening committee, of which 265 were included in the primary analysis population. The 30-day rate of death, stroke, or MI was 3.0% (95% confidence interval: 1.3% to 5.9%) and the stroke or death rate was 1.5%. The 30-day stroke rate was 1.1%. The 2 deaths in the study were not stroke related.
Low death, stroke, or MI rates were demonstrated with GCS in patients at high risk for CEA. The 30-day stroke rate of 1.1% suggests that the carotid stent mesh covering may reduce the neurologic events associated with CAS when used in appropriately selected patients.
本研究的主要目的是复合 30 天内主要不良事件或同侧卒中（30 天至 1 年）。此处介绍的是 30 天内死亡、卒中和心肌梗死（MI）的复合。
与颈动脉内膜切除术（CEA）相比，颈动脉支架置入术（CAS）的小卒中发生率更高。该研究假设，具有网孔覆盖的支架可能在 CAS 期间改善斑块稳定性，减少斑块突出，并降低卒中发生率。
前瞻性、多中心、单臂临床试验 SCAFFOLD 试验评估了戈尔颈动脉支架（GCS），入组了因 CEA 不良事件风险增加且颈动脉狭窄严重（定义为症状性≥50%或无症状性≥80%）的患者。SCAFFOLD 试验筛选委员会的实施是为了确定对研究方案的遵守情况。对患者进行了主要终点评估，即 30 天内死亡、卒中和 MI 的复合。
共有 312 例患者入组、治疗并由 SCAFFOLD 试验筛选委员会进行了审查，其中 265 例患者被纳入主要分析人群。30 天内的死亡率、卒中和 MI 发生率为 3.0%（95%置信区间：1.3%至 5.9%），卒中或死亡率为 1.5%。30 天内卒中发生率为 1.1%。研究中的 2 例死亡与卒中无关。
在 CEA 高危患者中，GCS 显示出低的死亡、卒中和 MI 发生率。30 天卒中发生率为 1.1%，表明在适当选择的患者中，颈动脉支架网孔覆盖可能会降低与 CAS 相关的神经事件。
