Department of Surgery, UC San Diego, San Diego, CA.
Center for Learning and Excellence in Vascular and Endovascular Research (CLEVER), UC San Diego, San Diego, CA.
Ann Surg. 2023 Oct 1;278(4):559-567. doi: 10.1097/SLA.0000000000006009. Epub 2023 Jul 13.
Carotid endarterectomy (CEA) remains the gold standard procedure for carotid revascularization. Transfemoral carotid artery stenting (TFCAS) was introduced as a minimally invasive alternative procedure in patients who are at high risk for surgery. However, TFCAS was associated with an increased risk of stroke and death compared to CEA.
Transcarotid artery revascularization (TCAR) has outperformed TFCAS in several prior studies and has shown similar perioperative and 1-year outcomes compared with CEA. We aimed to compare the 1-year and 3-year outcomes of TCAR versus CEA in the Vascular Quality Initiative (VQI)-Medicare-Linked [Vascular Implant Surveillance and Interventional Outcomes Network (VISION)] database.
The VISION database was queried for all patients undergoing CEA and TCAR between September 2016 to December 2019. The primary outcome was 1-year and 3-year survival. One-to-one propensity-score matching (PSM) without replacement was used to produce 2 well-matched cohorts. Kaplan-Meier estimates, and Cox regression was used for analyses. Exploratory analyses compared stroke rates using claims-based algorithms for comparison.
A total of 43,714 patients underwent CEA and 8089 patients underwent TCAR during the study period. Patients in the TCAR cohort were older and were more likely to have severe comorbidities. PSM produced two well-matched cohorts of 7351 pairs of TCAR and CEA. In the matched cohorts, there were no differences in 1-year death [hazard ratio (HR)=1.13; 95% CI, 0.99-1.30; P =0.065]. At 3-years, TCAR was associated with slight increased risk of death (HR=1.16; 95% CI, 1.04-1.30; P =0.008). When stratifying by initial symptomatic presentation, the increased 3-year death associated with TCAR persisted only in symptomatic patients (HR=1.33; 95% CI, 1.08-1.63; P =0.008). Exploratory analyses of postoperative stroke rates using administrative sources suggested that validated measures of claims-based stroke ascertainment are necessary.
In this large multi-institutional PSM analysis with robust Medicare-linked follow-up for survival analysis, the rate of death at 1 year was similar in TCAR and CEA regardless of symptomatic status. The slight increase in the risk of 3-year death in symptomatic patients undergoing TCAR is likely confounded by more severe comorbidities despite matching. A randomized controlled trial comparing TCAR to CEA is necessary to further determine the role of TCAR in standard-risk patients requiring carotid revascularization.
颈动脉内膜切除术（CEA）仍然是颈动脉血运重建的金标准手术。经股动脉颈动脉支架置入术（TFCAS）作为一种微创替代手术，已在手术风险较高的患者中应用。然而，与 CEA 相比，TFCAS 与卒中风险和死亡风险增加相关。
在几项先前的研究中，经颈动脉血管重建术（TCAR）的表现优于 TFCAS，并且与 CEA 相比，围手术期和 1 年的结果相似。我们旨在比较血管质量倡议（VQI）-医疗保险相关[血管植入物监测和介入结果网络（VISION）]数据库中 TCAR 与 CEA 的 1 年和 3 年结果。
在 2016 年 9 月至 2019 年 12 月期间，对接受 CEA 和 TCAR 的所有患者进行了 VISION 数据库查询。主要结果是 1 年和 3 年生存率。采用无替换的 1:1 倾向评分匹配（PSM）生成 2 个匹配良好的队列。使用 Kaplan-Meier 估计和 Cox 回归进行分析。探索性分析使用基于索赔的算法比较卒中发生率。
研究期间共有 43714 例患者接受了 CEA，8089 例患者接受了 TCAR。TCAR 组患者年龄较大，合并症更为严重。PSM 生成了 7351 对 TCAR 和 CEA 的匹配良好的队列。在匹配的队列中，1 年死亡率无差异[风险比（HR）=1.13；95%置信区间，0.99-1.30；P=0.065]。3 年时，TCAR 与死亡风险略有增加相关（HR=1.16；95%置信区间，1.04-1.30；P=0.008）。按初始症状表现分层时，与 TCAR 相关的 3 年死亡率增加仅见于症状性患者（HR=1.33；95%置信区间，1.08-1.63；P=0.008）。使用行政源对术后卒中发生率进行的探索性分析表明，需要验证基于索赔的卒中确定的测量方法。
在这项具有强大医疗保险相关生存分析随访的大型多机构 PSM 分析中，TCAR 和 CEA 术后 1 年的死亡率相似，无论症状状态如何。尽管进行了匹配，但在接受 TCAR 的症状性患者中，3 年死亡风险略有增加，可能与更严重的合并症有关。需要进行 TCAR 与 CEA 的随机对照试验，以进一步确定 TCAR 在需要颈动脉血运重建的标准风险患者中的作用。
