Section of Vascular Surgery, Heart and Vascular Center (J.A.C., D.H.S., P.P.G.), Dartmouth-Hitchcock Medical Center, Lebanon, NH.
Geisel School of Medicine at Dartmouth College, Hanover, NH (J.A.C., D.H.S., P.P.G., A.J.O.).
Circ Cardiovasc Interv. 2023 Sep;16(9):e012805. doi: 10.1161/CIRCINTERVENTIONS.122.012805. Epub 2023 Sep 19.
In 2015, the FDA approved transcarotid artery revascularization (TCAR) as an alternative to carotid endarterectomy (CEA) and transfemoral carotid artery stenting (TF-CAS) for high-risk patients with carotid stenosis. This was granted in the absence of level 1 evidence to support TCAR. We aimed to document trends in TCAR utilization, its diffusion over time, and the clinical phenotypes of patients undergoing TCAR, CEA, and TF-CAS.
We used the Vascular Quality Initiative to study patients who underwent TCAR. We calculated the number of TCARs performed and the percent of TCAR utilization versus CEA/TF-CAS. Using data from before TCAR was widespread, we calculated propensity scores for patients to receive CEA. We applied this model to patients undergoing carotid revascularization from 2016 to 2022 and grouped patients by the procedure they ultimately underwent, examining overlap in score distribution to measure patient similarity. We measured the trend of in-hospital stroke/death after TCAR.
We studied 31 447 patients who underwent TCAR from January 1, 2016 to March 31, 2022. The number of centers performing TCAR increased from 29 to 606. In 2021, TCAR represented 22.5% of carotid revascularizations at centers offering all 3 procedures. The percentage of patients that underwent TCAR who met approved high-risk criteria decreased from 88.5% to 80.9% (<0.001). Those with a prior ipsilateral carotid procedure decreased from 20.6% in 2016 to 12.0% in 2021 (<0.001). Patients undergoing TCAR after stroke increased from 19.7% to 30.7% (<0.001). Propensity-score overlap was 55.4% for TCAR/CEA, and 58.6% for TCAR/TF-CAS, demonstrating that TCAR patients have a clinical phenotype mixed between those who undergo CEA and TF-CAS. The average in-hospital stroke/death risk after TCAR was 2.3% in 2016 and 1.7% in 2022 ( trend: 0.954).
TCAR now represents nearly 1-in-4 procedures at centers offering it. TCAR was increasingly performed among standard-risk patients and as a first-line procedural option after stroke. The absence of level 1 evidence underscores the importance of high-quality registry-based analyses to document TCAR's real-world outcomes and durability.
2015 年，美国食品药品监督管理局（FDA）批准经颈动脉血管重建术（TCAR）作为颈动脉内膜切除术（CEA）和经股动脉颈动脉支架置入术（TF-CAS）的替代方法，用于治疗颈动脉狭窄的高危患者。这是在缺乏支持 TCA 的一级证据的情况下批准的。我们旨在记录 TCA 使用的趋势、随时间的扩散情况，以及接受 TCA、CEA 和 TF-CAS 治疗的患者的临床表型。
我们使用血管质量倡议（Vascular Quality Initiative）研究了接受 TCA 的患者。我们计算了进行的 TCA 数量以及 TCA 与 CEA/TF-CAS 的使用率百分比。利用 TCA 广泛应用之前的数据，我们计算了患者接受 CEA 的倾向评分。我们将该模型应用于 2016 年至 2022 年接受颈动脉血运重建的患者，并根据他们最终接受的治疗程序对患者进行分组，通过比较评分分布来衡量患者的相似性。我们测量了 TCA 后住院期间卒中/死亡的趋势。
我们研究了 2016 年 1 月 1 日至 2022 年 3 月 31 日期间接受 TCA 的 31447 名患者。开展 TCA 的中心数量从 29 个增加到 606 个。2021 年，在提供所有 3 种治疗方法的中心中，TCA 占颈动脉血运重建的 22.5%。符合批准的高危标准的接受 TCA 治疗的患者比例从 88.5%降至 80.9%（<0.001）。在同侧颈动脉有既往手术史的患者比例从 2016 年的 20.6%降至 2021 年的 12.0%（<0.001）。卒中后接受 TCA 的患者比例从 19.7%增加到 30.7%（<0.001）。TCAR/CEA 的倾向评分重叠率为 55.4%，TCAR/TF-CAS 的重叠率为 58.6%，这表明 TCA 患者的临床表型介于接受 CEA 和 TF-CAS 治疗的患者之间。TCA 后住院期间卒中/死亡的平均风险从 2016 年的 2.3%降至 2022 年的 1.7%（趋势：0.954）。
TCAR 现在代表了提供该治疗的中心近 1/4 的手术。TCAR 越来越多地用于标准风险患者，并且是卒中后一线治疗选择。缺乏一级证据强调了基于高质量登记的分析的重要性，以记录 TCA 的真实世界结果和耐久性。
