Lin Yue, Lv Fanzhen, Huang Yulong, Chen Gang, Hong Shichai, Hong Xiang, Xie Xinsheng, Lu Weifeng, Fu Weiguo
Department of Vascular Surgery, Xiamen Branch, Zhongshan Hospital, Fudan University, Xiamen 361015, China.
Department of Vascular Surgery, Zhongshan Hospital, Fudan University, Shanghai 200032, China.
Biomedicines. 2025 Jun 5;13(6):1384. doi: 10.3390/biomedicines13061384.
: The objective of this study was to evaluate the real-world efficacy of minimally invasive revascularization in diabetic foot ischemia, focusing on novel insights into device selection and lesion-specific predictors. : This retrospective study included 98 patients (101 limbs) undergoing endovascular/hybrid interventions. The primary endpoints were 1- and 2-year primary patency and freedom from clinically driven target lesion revascularization (CD-TLR). Multivariate Cox regression identified restenosis predictors, with subgroup analysis comparing drug-coated devices (DCDs) versus conventional strategies in chronic limb-threatening ischemia (CLTI). : The cohort (mean age 72.1 ± 8.9 years) comprised 51% CLTI limbs (28.5% with tissue loss). The overall 1-year primary patency was 75.6%, declining to 67.6% after 2 years. The rates of freedom from CD-TLR were 87.4% after 1 year and 74.8% after 2 years. CLTI was associated with significantly reduced 1-year (66.5% vs. 84.9%) and 2-year primary patency (56.3% vs. 80.1%; log-rank = 0.026) compared to non-CLTI. Multivariate analysis identified CLTI as an independent predictor of restenosis (HR 3.375, 95%CI 1.267-8.990, = 0.015). Although DCDs did not improve 2-year primary patency in CLTI (58.5% vs. 57.3%, = 0.768), they demonstrated superior 2-year CD-TLR-free survival (78.5% vs. 54.6%, = 0.048). The total complication rate was 5.9%, with no significant difference between CLTI and non-CLTI groups (11.5% vs. 0%, = 0.057). : This study highlights CLTI's impact on revascularization durability and the clinical benefits of DCDs in reducing reinterventions, offering evidence-based insights for tailored device selection despite retrospective limitations.
本研究的目的是评估微创血运重建术在糖尿病足缺血中的实际疗效,重点关注器械选择和病变特异性预测因素的新见解。本回顾性研究纳入了98例接受血管内/杂交干预的患者(101条肢体)。主要终点是1年和2年的主要通畅率以及免于临床驱动的靶病变血运重建(CD-TLR)。多变量Cox回归确定了再狭窄的预测因素,并进行亚组分析比较药物涂层器械(DCDs)与慢性肢体威胁性缺血(CLTI)的传统治疗策略。该队列(平均年龄72.1±8.9岁)中,CLTI肢体占51%(28.5%有组织缺失)。总体1年主要通畅率为75.6%,2年后降至67.6%。1年后免于CD-TLR的比例为87.4%,2年后为74.8%。与非CLTI相比,CLTI与1年(66.5%对84.9%)和2年主要通畅率显著降低相关(56.3%对80.1%;对数秩检验=0.026)。多变量分析确定CLTI是再狭窄的独立预测因素(风险比3.375,95%置信区间1.267 - 8.990,P = 0.015)。虽然DCDs在CLTI中未改善2年主要通畅率(58.5%对57.3%,P = 0.768),但它们显示出更好的2年无CD-TLR生存率(78.5%对54.6%,P = 0.048)。总并发症发生率为5.9%,CLTI组和非CLTI组之间无显著差异(11.5%对0%,P = 0.057)。本研究强调了CLTI对血运重建耐久性的影响以及DCDs在减少再次干预方面的临床益处,尽管存在回顾性研究的局限性,但仍为定制器械选择提供了基于证据的见解。