Division of Vascular Surgery, Departement of Surgery, Johns Hopkins University School of Medicine, Baltimore, Md.
Division of Vascular and Endovascular Surgery, Department of Surgery, University of California San Diego, La Jolla, Calif.
J Vasc Surg. 2021 May;73(5):1639-1648. doi: 10.1016/j.jvs.2020.08.155. Epub 2020 Oct 17.
The association between stent design and outcomes after carotid artery stenting (CAS) has remained controversial. The available data are conflicting regarding the superiority of any specific stent design. The present study investigated the association between cell design and outcomes after carotid artery stenting (CAS) in a real world setting.
Patients who had undergone CAS with distal embolic protection in the Society for Vascular Surgery Vascular Quality Initiative (VQI) database from 2016 to 2018 were included in the present study. Patients undergoing CAS for trauma or dissection or more than two treated lesions were excluded. We also excluded lesions for which more than two carotid stents had been used and lesions confined to the common or external carotid artery. Univariable and multivariable logistic regression analyses were used to compare the outcomes after CAS between the open- and closed-cell stent designs.
Of the 2671 CAS procedures included in the present analysis, 1384 (51.8%) had used closed-cell stents and 1287 (48.2%) had used open-cell stents. On univariable analysis, no significant differences were noted between the closed- and open-cell stents in in-hospital mortality (1.8% vs 1.4%; P = .40), stroke (1.8% vs 2.4%; P = .28), and stroke/death (3.3% vs 3.5%; P = .81). After adjusting for potential confounders (ie, age, symptomatic status, previous major amputation, statin and antiplatelet use, American Society of Anesthesiologists class, elective procedures, approach, and post-stent dilatation), no difference was noted in in-hospital stroke/death between the two stent designs (odds ratio [OR], 1.08; 95% confidence interval [CI], 0.68-1.74; P = .74). However, the interaction between stent design (open vs closed) and lesion location (bifurcation vs internal carotid artery [ICA]) was statistically significant (P = .02). Closed-cell stents were associated with five times the odds of in-hospital stroke/death when used in carotid artery bifurcation (OR, 5.5; 95% CI, 1.3-22.2; P = .02). However, when the stent was limited to the ICA, no differences were noted (OR, 0.87; 95% CI, 0.51-1.45; P = .62). One-year follow-up data were available for 19% of patients. No differences in ipsilateral stroke or death at 1 year were noted between the open- and closed-cell stents, except when the lesion was located in the carotid bifurcation (hazard ratio, 6.7; 95% CI, 1.4-31.4; P = .02).
Closed-cell stents were associated with an increased odds of in-hospital stroke/death for carotid bifurcation lesions, which might be related to the relatively lower conformability of closed-cell stents in the tortuous and diameter-mismatched bifurcation anatomy vs the relatively linear uniform diameter of the ICA. Improved follow-up and in-depth analysis of lesion-specific characteristics that might influence the outcomes of these two designs are needed to validate these results.
颈动脉支架置入术(CAS)后支架设计与结果之间的关系一直存在争议。关于任何特定支架设计的优越性,现有数据存在冲突。本研究旨在真实世界环境中研究颈动脉支架置入术(CAS)后细胞设计与结果之间的关系。
纳入 2016 年至 2018 年在血管外科学会血管质量倡议(VQI)数据库中接受远端保护下 CAS 的患者。排除因创伤、夹层或超过两个治疗病变而接受 CAS 的患者。我们还排除了使用超过两个颈动脉支架治疗的病变和局限于颈总动脉或颈外动脉的病变。使用单变量和多变量逻辑回归分析比较两种支架设计后 CAS 的结果。
在本分析纳入的 2671 例 CAS 手术中,1384 例(51.8%)使用了闭孔支架,1287 例(48.2%)使用了开孔支架。单变量分析显示,闭孔支架和开孔支架的院内死亡率(1.8%比 1.4%;P=0.40)、卒中(1.8%比 2.4%;P=0.28)和卒中和死亡(3.3%比 3.5%;P=0.81)无显著差异。在调整潜在混杂因素(即年龄、症状状态、既往大截肢、他汀类药物和抗血小板药物使用、美国麻醉师协会分级、择期手术、入路和支架后扩张)后,两种支架设计的院内卒中和死亡无差异(比值比[OR],1.08;95%置信区间[CI],0.68-1.74;P=0.74)。然而,支架设计(开/闭)和病变位置(分叉/颈内动脉[ICA])之间的交互作用具有统计学意义(P=0.02)。当分叉病变使用闭孔支架时,院内卒中和死亡的风险增加五倍(OR,5.5;95%CI,1.3-22.2;P=0.02)。然而,当支架仅限于 ICA 时,无差异(OR,0.87;95%CI,0.51-1.45;P=0.62)。19%的患者有 1 年的随访数据。除病变位于颈动脉分叉处外,开孔支架和闭孔支架在 1 年内同侧卒中或死亡无差异(风险比,6.7;95%CI,1.4-31.4;P=0.02)。
对于颈动脉分叉病变,闭孔支架与较高的院内卒中和死亡风险相关,这可能与闭孔支架在迂曲和直径不匹配的分叉解剖中的相对较低顺应性有关,而 ICA 的相对线性均匀直径有关。需要进一步随访和深入分析可能影响这两种设计结果的病变特异性特征,以验证这些结果。