目的:经颈动脉血管重建术(TCAR)已被实践为颈动脉内膜切除术(CEA)和经股颈动脉支架置入术(TFCAS)的替代方法,特别是在高危患者中。最近,如果在SVS/血管质量计划(SVS/VQI)TCAR监测项目中进行,CMS扩大了TCAR在标准手术风险患者中的覆盖范围。一些注册研究(主要来自SVS/VQI)比较了TCAR与CEA或TFCAS的早期和长达一年的结果。没有大型单中心研究报告晚期临床结果。本研究将比较TCAR与CEA的中间临床结果。
方法:本研究回顾性分析了在我们机构注册的TCAR监测项目患者的数据,并将其与相同提供者在同一时间段进行的CEA患者进行比较。主要结局是合并围手术期卒中/死亡和晚期卒中/死亡。次要结果包括合并卒中,死亡和MI,颅神经损伤(CNI),和出血。进行倾向匹配以分析结果。KaplanMyer分析用于评估卒中的自由度,中风/死亡,≥50%和≥80%再狭窄。
结果:646例手术(637例患者)(404CEA,242TCAR)进行了分析。颈动脉介入的指征没有显着差异。然而,TCAR患者有更多的高风险标准,包括高血压,冠状动脉疾病,充血性心力衰竭,和肾衰竭。在围手术期30天的卒中中中,CEA与TCAR之间没有显着差异(1%对2%),卒中/死亡率(1%对3%,p=0.0849),或重大血肿(2%对2%)。CNI的发生率有显著差异(CEA为5%,TCAR为1%,p=0.0138)。在后期随访(2年),中风率为1%对4%(p=0.0273),中风/死亡8%对15%(p0.008),CEA患者与TCAR患者的再狭窄≥80%,分别为0.5%和3%(p0.0139)。在匹配242个CEA和242个TCAR之后,围手术期卒中发生率CEA为1%vsTCAR为2%(p=0.5037),卒中/死亡率为2%对3%(p=0.2423),CNI率为3%对1%(p=0.127)。在晚期随访时,中风的发生率为,CEA为1%,TCAR为4%(p=0.0615),中风/死亡,8%对15%(p=0.0345)。CEA≥80%再狭窄率为0.9%,TCAR为3%(p=0.099)。CEA与TCAR在6、12、18和24个月时的卒中自由率为:99%,99%,99%,99%和97%,95%,93%和93%;p=0.0806,中风/死亡:94%,90%,87%,86%对93%,87%,76%,和75%;p=0.0529,并且≥80%再狭窄:100%,99%,98%,98%和97%,95%,93%,和93%;p=0.1132。
结论:在倾向匹配分析中,CEA和TCAR的围手术期临床结局相似.然而,在晚期卒中/死亡率方面,CEA优于TCAR,并且在2年时的再狭窄率≥80%,但无统计学意义。
BACKGROUND: Transcarotid artery revascularization (TCAR) has been practiced as an alternative for both carotid endarterectomy (CEA) and transfemoral carotid artery stenting, specifically in high-risk patients. More recently, the Centers for Medicare and Medicaid Services expanded coverage for TCAR in standard surgical risk patients if done within the Society for Vascular Surgery Vascular Quality Initiative TCAR surveillance project. A few registry studies (primarily from the Society for Vascular Surgery Vascular Quality Initiative) compared the early and up to 1-year outcomes of TCAR vs CEA or transfemoral carotid artery stenting. There is no large single-center study that reported late clinical outcomes. The present study compares intermediate clinical outcomes of TCAR vs CEA.
METHODS: This study retrospectively analyzed collected data from TCAR surveillance project patients enrolled in our institution and compare it with CEA patients done by the same providers at the same time period. The primary outcome was combined perioperative stroke/death and late stroke/death. Secondary outcomes included combined stroke, death, and myocardial infarction, cranial nerve injury (CNI), and bleeding. Propensity matching was done to analyze outcome. Kaplan-Meier analysis was used to estimate freedom from stroke, stroke/death, and ≥50% and ≥80% restenosis.
RESULTS: We analyzed 646 procedures (637 patients) (404 CEA, 242 TCAR). There was no significant difference in the indications for carotid intervention. However, TCAR patients had more high-risk criteria, including hypertension, coronary artery disease, congestive heart failure, and renal failure. There was no significant differences between CEA vs TCAR in 30-day perioperative stroke (1% vs 2%), stroke/death rate (1% vs 3%; P = .0849), or major hematomas (2% vs 2%). The rate of CNI was significantly different (5% for CEA vs 1% for TCAR; P = .0138). At late follow-up (2 years), the rate of stroke was 1% vs 4% (P = .0273), stroke/death 8% vs 15% (P = .008), ≥80 % restenosis 0.5% vs 3% (P = .0139) for CEA patients vs TCAR patients, respectively. After matching 242 CEAs and 242 TCARs, the perioperative stroke rate was 1% for CEA vs 2% for TCAR (P = .5037), the stroke/death rate was 2% vs 3% (P = .2423), and the CNI rate was 3% vs 1% (P = .127). At late follow-up, rates of stroke were 1% for CEA vs 4% for TCAR (P = .0615) and stroke/death were 8% vs 15% (P = .0345). The rate of ≥80% restenosis was 0.9% for CEA vs 3% for TCAR (P = .099). The rates of freedom from stroke at 6, 12, 18, and 24 months for CEA vs TCAR were 99%, 99%, 99%, and 99% vs 97%, 95%, 93% and 93%, respectively (P = .0806); stroke/death were 94%, 90%, 87%, and 86% vs 93%, 87%, 76%, and 75%, respectively (P = .0529); and ≥80% restenosis were 100%, 99%, 98%, and 98% vs 97%, 95%, 93%, and 93%, respectively (P = .1132).
CONCLUSIONS: In a propensity-matched analysis, both CEA and TCAR have similar perioperative clinical outcomes. However, CEA was superior to TCAR for the rates of late stroke/death and had a somewhat lower rate of ≥80% restenosis at 2 years, but this difference was not statistically significant.