Ochoa Chaar Cassius Iyad, Malas Mahmoud, Doros Gheorghe, Schermerhorn Marc, Conte Michael S, Alameddine Dana, Siracuse Jeffrey J, Yadavalli Sai Divya, Dake Michael D, Creager Mark A, Tan Tze-Woei, Rosenfield Kenneth, Menard Matthew T, Farber Alik, Hamdan Allen
Division of Vascular Surgery and Endovascular Therapy, Department of Surgery, Yale University School of Medicine, New Haven, CT.
Department of Vascular and Endovascular Surgery, University of California San Diego, La Jolla, CA.
J Vasc Surg. 2025 Feb;81(2):376-385.e3. doi: 10.1016/j.jvs.2024.09.026. Epub 2024 Sep 25.
Several observational studies have demonstrated an association between diabetes mellitus (DM) and above-ankle amputation after lower extremity revascularization (LER). However, data from prospective randomized trials is lacking. This analysis compares the outcomes of patients with and without DM enrolled in the Best Endovascular vs Best Surgical Therapy in patients with Chronic Limb-Threatening Ischemia (BEST-CLI) trial.
Baseline characteristics were compared between patients with and without DM in the BEST-CLI trial. Cox regression was used to determine the association between DM and major outcomes of major adverse limb events (MALE), reintervention, above-ankle amputation, and all-cause death.
Among 1777 patients who underwent LER, 69.2% had DM. Compared with patients without DM, those with DM were significantly younger, less likely to be White, and more likely to be Hispanic. Patients with DM were more likely to have hypertension, hyperlipidemia, coronary artery disease, congestive heart failure, and renal disease and be on optimal medical therapy (antiplatelets and statins), whereas patients without DM were significantly more likely to be smokers and have chronic obstructive pulmonary disease. Patients with DM were significantly more likely to present with late Wound Ischemia foot Infection (WIfI) stages (3-4) (73.7% vs 45.9%; P < .001) that were driven predominantly by differences in wound and infection grade. Conversely, patients without DM had significantly lower ankle pressures and toe pressures and were significantly more likely to have WIfI ischemia grade 3 compared with patients with DM (60% vs 52.5%; P = .016). At 3 years, patients with DM exhibited higher rates of above-ankle amputation and all-cause death compared with patients without DM. Kaplan-Meier analysis demonstrated significantly higher MALE or all-cause death compared with patients without DM (3-year estimate: 53.5% vs 46.4%; P < .001). After adjusting for potential confounders, regression analysis demonstrated that DM was independently associated with increased above-ankle amputation (1.75 [1.22-2.51]), all-cause death (1.63 [1.31-2.03]), and MALE or all-cause death (1.24 [1.04-1.47]).
Patients with DM undergoing LER for chronic limb-threatening ischemia experienced a greater incidence of MALE or all-cause death compared with patients without DM. The impact of DM seems to be mediated by more severe wounds and infections at the time of presentation, and a higher prevalence of cardiac and renal disease.
多项观察性研究已证实糖尿病（DM）与下肢血管重建术（LER）后踝关节以上截肢之间存在关联。然而，缺乏前瞻性随机试验的数据。本分析比较了参与慢性肢体威胁性缺血患者最佳血管内治疗与最佳手术治疗（BEST-CLI）试验的糖尿病患者和非糖尿病患者的结局。
在BEST-CLI试验中比较糖尿病患者和非糖尿病患者的基线特征。采用Cox回归确定糖尿病与主要不良肢体事件（MALE）、再次干预、踝关节以上截肢和全因死亡等主要结局之间的关联。
在1777例行LER的患者中，69.2%患有DM。与非糖尿病患者相比，糖尿病患者明显更年轻，白人比例更低，西班牙裔比例更高。糖尿病患者更易患高血压、高脂血症、冠状动脉疾病、充血性心力衰竭和肾病，且接受最佳药物治疗（抗血小板药物和他汀类药物），而非糖尿病患者吸烟和患慢性阻塞性肺疾病的可能性显著更高。糖尿病患者出现晚期伤口缺血性足部感染（WIfI）3-4期的可能性显著更高（73.7%对45.9%；P <.001），这主要是由伤口和感染分级差异所致。相反，与糖尿病患者相比，非糖尿病患者的踝关节压力和趾端压力显著更低，且WIfI缺血3级的可能性显著更高（60%对52.5%；P = 0.016）。3年时，糖尿病患者的踝关节以上截肢率和全因死亡率高于非糖尿病患者。Kaplan-Meier分析显示，与非糖尿病患者相比，MALE或全因死亡显著更高（3年估计值：53.5%对46.4%；P <.001）。在调整潜在混杂因素后，回归分析表明，糖尿病与踝关节以上截肢增加（1.75 [1.22 - 2.51]）、全因死亡（1.63 [1.31 - 2.03]）以及MALE或全因死亡（1.24 [1.04 - 1.47]）独立相关。
与非糖尿病患者相比，因慢性肢体威胁性缺血接受LER的糖尿病患者发生MALE或全因死亡的发生率更高。糖尿病的影响似乎是由就诊时更严重的伤口和感染以及心脏和肾脏疾病的较高患病率介导的。
