Gray William A, Hopkins L Nelson, Yadav Sanjay, Davis Thomas, Wholey Mark, Atkinson Richard, Cremonesi Alberto, Fairman Ronald, Walker Gary, Verta Patrick, Popma Jeff, Virmani Renu, Cohen David J
Columbia University Medical Center, New York, NY 10032, USA.
J Vasc Surg. 2006 Aug;44(2):258-68. doi: 10.1016/j.jvs.2006.03.044.
Carotid endarterectomy is the standard of care for most patients with severe extracranial carotid bifurcation disease. However, its safety and efficacy in patients with significant surgical risk are unclear. The ARCHeR (ACCULINK for Revascularization of Carotids in High-Risk patients) trial was performed to determine whether carotid artery stenting with embolic protection is a safe and effective alternative to endarterectomy in high-surgical-risk patients.
The ARCHeR trial is a series of three sequential, multicenter, nonrandomized, prospective studies. Forty-eight sites enrolled 581 high-surgical-risk patients between May 2000 and September 2003. Patients with severe carotid artery stenosis (angiographically defined, symptomatic > or =50%, or asymptomatic > or =80%) had an ACCULINK nitinol stent implanted. The ACCUNET filter embolic protection system was added to the procedure in the final 2 studies (422 patients). The primary efficacy end point was a composite of periprocedural (< or =30 days) death, stroke, and myocardial infarction, plus ipsilateral stroke between days 31 and 365.
The 30-day rate of death/stroke/myocardial infarction was 8.3% (95% confidence interval [CI], 6.2%-10.8%), and that of stroke/death was 6.9% (95% CI, 5.0%-9.3%). Most (23/32) strokes were minor, of which more than half (12/23) returned to baseline National Institutes of Health Stroke Scale scores within 30 days. The 30-day major/fatal stroke rate was 1.5% (95% CI, 0.7%-2.9%). No hemorrhagic strokes were observed in the study. Ipsilateral cerebrovascular accident occurred in 1.3% between 30 days and 1 year, thus giving a primary composite end point of 30-day death/stroke/myocardial infarction plus ipsilateral stroke at 1 year of 9.6% (95% CI, 7.2%-12.0%), which is below the 14.4% historical control comparator. Target lesion revascularization at 12 months and 2 years was 2.2% and 2.9%, respectively.
The ARCHeR results demonstrate that extracranial carotid artery stenting with embolic filter protection is not inferior to historical results of endarterectomy and suggest that carotid artery stenting is a safe, durable, and effective alternative in high-surgical-risk patients.
颈动脉内膜切除术是大多数重度颅外颈动脉分叉病变患者的标准治疗方法。然而，其在手术风险较高患者中的安全性和有效性尚不清楚。开展ARCHeR（高危患者颈动脉血运重建的ACCULINK）试验以确定在高手术风险患者中，使用栓子保护装置的颈动脉支架置入术是否是一种安全有效的替代内膜切除术的方法。
ARCHeR试验是一系列连续的三项多中心、非随机、前瞻性研究。在2000年5月至2003年9月期间，48个研究点纳入了581例高手术风险患者。患有严重颈动脉狭窄（血管造影定义为，有症状的≥50%，或无症状的≥80%）的患者植入了ACCULINK镍钛合金支架。在最后两项研究（422例患者）中，手术过程中增加了ACCUNET滤器栓子保护系统。主要疗效终点是围手术期（≤30天）死亡、卒中、心肌梗死的复合终点，加上第31天至365天之间的同侧卒中。
30天死亡/卒中/心肌梗死发生率为8.3%（95%置信区间[CI]，6.2%-10.8%），卒中/死亡发生率为6.9%（95%CI，5.0%-9.3%）。大多数（23/32）卒中为轻度，其中超过一半（12/23）在30天内恢复至美国国立卫生研究院卒中量表基线评分。30天严重/致死性卒中发生率为1.5%（95%CI，0.7%-2.9%）。研究中未观察到出血性卒中。30天至1年之间同侧脑血管意外发生率为1.3%，因此30天死亡/卒中/心肌梗死加上1年时同侧卒中的主要复合终点为9.6%（95%CI，7.2%-12.0%），低于14.4%的历史对照比较值。12个月和2年时的靶病变血运重建率分别为2.2%和2.9%。
ARCHeR试验结果表明，使用栓子滤器保护的颅外颈动脉支架置入术并不逊于内膜切除术的历史结果，并提示在高手术风险患者中，颈动脉支架置入术是一种安全、持久且有效的替代方法。
