Yamada Takehiro, Tokuda Takahiro, Yoshioka Naoki, Koyama Akio, Nishikawa Ryusuke, Shimamura Kiyotaka, Aoyama Takuma
Division of Cardiology Central Japan International Medical Center Gifu Japan.
Division of Cardiology Nagoya Heart Center Nagoya Japan.
Health Sci Rep. 2023 Aug 3;6(8):e1481. doi: 10.1002/hsr2.1481. eCollection 2023 Aug.
Polymer-coated drug-eluting stents (Eluvia) have shown favorable clinical outcomes in real-world registries. There are no reports on recurrent predictors after Eluvia placement based on intravascular ultrasound (IVUS) findings.
We analyzed clinical data from the ASIGARU PAD registry, a retrospective, multicenter, observational study that enrolled patients who underwent endovascular therapy for superficial femoral and proximal popliteal arteries lesions using Eluvia or drug-coated balloon. The primary outcome was the identification of recurrent predictors, including IVUS parameters at 12 months. The rate of target lesion recurrence was also assessed.
IVUS images were obtained in 54 of 65 cases. Seven recurrent cases (13.0%) were observed within 12 months. The random survival forest method presented eight predictive variables of recurrence: Clinical Frailty Scale (CFS), distal stent edge area, distal plaque burden, age, sex, distal external elastic membrane (EEM) area, minimum stent area (MSA), and distal lumen area. Furthermore, the partial dependence plot showed that frailty (CFS ≥ 6), smaller distal stent edge area, higher and lower distal plaque burden, older and younger age, female sex, smaller distal EEM area, smaller MSA, and smaller and larger distal lumen area predicted recurrence after Eluvia placement within 12 months.
CFS, distal stent edge area, distal plaque burden, age, sex, distal EEM area, MSA, and distal lumen area were significant recurrent predictors after Eluvia placement.
聚合物涂层药物洗脱支架（Eluvia）在真实世界注册研究中已显示出良好的临床结果。目前尚无基于血管内超声（IVUS）结果的Eluvia置入术后复发预测因素的相关报道。
我们分析了ASIGARU PAD注册研究的临床数据，这是一项回顾性、多中心、观察性研究，纳入了使用Eluvia或药物涂层球囊对股浅动脉和腘动脉近端病变进行血管内治疗的患者。主要结局是确定复发预测因素，包括12个月时的IVUS参数。还评估了靶病变复发率。
65例患者中有54例获得了IVUS图像。在12个月内观察到7例复发病例（13.0%）。随机生存森林法呈现了8个复发预测变量：临床衰弱量表（CFS）、支架远端边缘面积、远端斑块负荷、年龄、性别、远端外弹力膜（EEM）面积、最小支架面积（MSA）和远端管腔面积。此外，偏倚依赖图显示，衰弱（CFS≥6）、较小的支架远端边缘面积、较高和较低的远端斑块负荷、年龄较大和较小、女性、较小的远端EEM面积、较小的MSA以及较小和较大的远端管腔面积可预测Eluvia置入术后12个月内的复发。
CFS、支架远端边缘面积、远端斑块负荷、年龄、性别、远端EEM面积、MSA和远端管腔面积是Eluvia置入术后显著的复发预测因素。
