Department of Angiology, Brandenburg Medical School Theodor Fontane, Campus Clinic Brandenburg, Brandenburg an der Havel and Sankt Gertrauden Hospital, Berlin, Germany -
Department of Vascular Surgery, St. Franziskus-Hospital, Münster, Germany.
J Cardiovasc Surg (Torino). 2024 Jun;65(3):205-212. doi: 10.23736/S0021-9509.24.13068-6.
The safety and efficacy of carotid artery stenting (CAS) can be affected by certain technical and anatomical factors. However, it is not known whether the use of a dual-layer micromesh stent (DLMS) with a low-crossing profile could reduce the risks associated with complex vascular anatomies during CAS.
This study involved 1965 asymptomatic or symptomatic carotid artery stenosis patients who received the Roadsaver DLMS during CAS, as part of a prospective, multicenter observational ROADSAVER study, conducted from January 2018 to February 2021. The primary outcome was the 30-day rate of major adverse events (MAE; i.e. any death or stroke) after CAS. Procedural details and outcomes were compared between patients with complex anatomical features and those without.
One or more complex anatomical characteristics were identified in 1639 (83.4%) patents. Patients with complex anatomies were older and had a higher prevalence of arterial hypertension, cardiovascular disease, and prior stroke. Between patients with or without complex anatomical features, no significant differences were found either in procedural techniques, or in 30-day MAE (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.76 (0.35, 1.66); p=0.4905) and any stroke (age-adjusted odds ratio (95% CI) for complexities vs. no complexities: 0.89 (0.37, 2.17); p=0.8032) incidence. Furthermore, neither the presence of specific types of anatomic complexity nor their number (per patient) markedly influenced the 30-day MAE and any stroke incidence.
In this real-world cohort of patients undergoing CAS with the Roadsaver DLMS, no significant difference in the occurrence of 30-day MAE and any stroke was observed between patients with or without high-risk anatomical features.
颈动脉支架置入术(CAS)的安全性和疗效可能受到某些技术和解剖因素的影响。然而,目前尚不清楚使用具有低交叉轮廓的双层微网支架(DLMS)是否可以降低在 CAS 期间与复杂血管解剖相关的风险。
本研究纳入了 1965 例接受 Roadsaver DLMS 行 CAS 的无症状或有症状颈动脉狭窄患者,该研究为前瞻性、多中心观察性 ROADSAVER 研究,于 2018 年 1 月至 2021 年 2 月进行。主要终点为 CAS 后 30 天内主要不良事件(MAE;即任何死亡或卒中)发生率。比较了具有复杂解剖特征和无复杂解剖特征患者的手术细节和结局。
1639 例(83.4%)患者存在 1 种或多种复杂解剖特征。具有复杂解剖特征的患者年龄较大,且动脉高血压、心血管疾病和既往卒中发生率较高。在具有或不具有复杂解剖特征的患者中,在手术技术或 30 天 MAE(复杂 vs. 不复杂的年龄调整比值比(95%CI):0.76(0.35,1.66);p=0.4905)和任何卒中(复杂 vs. 不复杂的年龄调整比值比(95%CI):0.89(0.37,2.17);p=0.8032)发生率方面,均无显著差异。此外,特定类型的解剖学复杂性的存在及其数量(每个患者)均不明显影响 30 天 MAE 和任何卒中发生率。
在本研究中,在接受 Roadsaver DLMS 行 CAS 的真实世界患者队列中,具有高危解剖特征的患者与无高危解剖特征的患者之间,30 天 MAE 和任何卒中的发生率无显著差异。