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来自大型单中心经验的经颈动脉血管重建术与颈动脉内膜切除术的临床结果。

Clinical outcomes of transcarotid artery revascularization vs carotid endarterectomy from a large single-center experience.

作者信息

AbuRahma Ali F, Santini Adrian, AbuRahma Zachary T, Lee Andrew, Veith Christina, Dargy Noah, Cragon Robert, Dean Scott, Mattox Elaine

机构信息

Department of Surgery, Charleston Area Medical Center/West Virginia University, Charleston, WV.

Department of Surgery, Charleston Area Medical Center/West Virginia University, Charleston, WV.

出版信息

J Vasc Surg. 2024 Jun;79(6):1402-1411.e3. doi: 10.1016/j.jvs.2024.01.213. Epub 2024 Feb 5.

Abstract

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.

摘要

背景

经颈动脉血管重建术(TCAR)已被用作颈动脉内膜切除术(CEA)和经股颈动脉支架置入术的替代方法,特别是在高危患者中。最近,如果在血管外科学会血管质量倡议TCAR监测项目范围内进行,医疗保险和医疗补助服务中心扩大了对标准手术风险患者的TCAR覆盖范围。一些注册研究(主要来自血管外科学会血管质量倡议)比较了TCAR与CEA或经股颈动脉支架置入术的早期及长达1年的结果。尚无大型单中心研究报告晚期临床结果。本研究比较了TCAR与CEA的中期临床结果。

方法

本研究回顾性分析了我们机构登记的TCAR监测项目患者收集的数据,并将其与同期由相同医疗人员进行的CEA患者的数据进行比较。主要结局是围手术期卒中/死亡和晚期卒中/死亡的合并发生率。次要结局包括卒中、死亡和心肌梗死的合并发生率、颅神经损伤(CNI)和出血。采用倾向匹配法分析结局。采用Kaplan-Meier分析来估计无卒中、卒中/死亡以及≥50%和≥80%再狭窄的发生率。

结果

我们分析了646例手术(637例患者)(404例CEA,242例TCAR)。颈动脉干预的指征没有显著差异。然而,TCAR患者有更多的高危标准,包括高血压、冠状动脉疾病、充血性心力衰竭和肾衰竭。CEA与TCAR在30天围手术期卒中发生率(1%对2%)、卒中/死亡率(1%对3%;P = 0.0849)或重大血肿发生率(2%对2%)方面没有显著差异。CNI发生率有显著差异(CEA为5%,TCAR为1%;P = 0.0138)。在晚期随访(2年)时,CEA患者与TCAR患者的卒中发生率分别为1%对4%(P = 0.0273),卒中/死亡率分别为8%对15%(P = 0.008),≥80%再狭窄率分别为0.5%对3%(P = 0.0139)。在匹配242例CEA和242例TCAR后,CEA围手术期卒中发生率为1%,TCAR为2%(P = 0.5037),卒中/死亡率为2%对3%(P = 0.2423),CNI发生率为3%对1%(P = 0.127)。在晚期随访时,CEA的卒中发生率为1%,TCAR为4%(P = 0.0615),卒中/死亡率为8%对15%(P = 0.0345)。CEA的≥80%再狭窄率为0.9%,TCAR为3%(P = 0.099)。CEA与TCAR在6、12、18和24个月时无卒中发生率分别为99%、99%、99%和99%,对应TCAR分别为97%、95%、93%和93%(P = 0.0806);卒中/死亡率分别为94%、90%、87%和86%,对应TCAR分别为93%、87%、76%和75%(P = 0.0529);≥80%再狭窄率分别为100%、99%、98%和98%,对应TCAR分别为97%、95%、93%和93%(P = 0.1132)。

结论

在倾向匹配分析中,CEA和TCAR的围手术期临床结果相似。然而,CEA在晚期卒中/死亡率方面优于TCAR,且在2年时≥80%再狭窄率略低,但这种差异无统计学意义。

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