Swiss Cardiovascular Center, Clinical and Interventional Angiology, Bern, Switzerland.
J Vasc Surg. 2011 Jun;53(6):1589-97. doi: 10.1016/j.jvs.2011.01.062. Epub 2011 Apr 30.
Patients with renal insufficiency (RI) are frequently excluded from trials assessing various endovascular revascularization concepts in critical limb ischemia (CLI) although information on clinical outcomes is scarce.
Consecutive patients with CLI undergoing endovascular lower limb revascularization during a 4.5-year time interval at a tertiary referral center were prospectively followed over a 12-month period. Patients were grouped according to renal function defined as normal (estimated glomerular filtration rate [eGFR] ≥ 60 mL/min/1.73 m(2); n = 108, 49.5%), moderate RI (eGFR ≥ 30-59 mL/min/1.73 m(2); n = 86, 39.5%) and severe RI, including dialysis (eGFR < 30 mL/min/1.73 m(2); n = 24, 11%). Clinical endpoints assessed were sustained clinical success, peri- and postprocedural mortality and major, above-the-ankle amputation. Sustained clinical improvement was defined as an upward shift of at least one category on the Rutherford classification compared with baseline to a level of claudication without repeated revascularization or unplanned amputation in surviving patients. Survival analysis was performed using the Kaplan-Meier method. Multivariate regression analysis was conducted in separate models for all above-mentioned clinical endpoints.
A total of 208 patients (218 limbs, mean age 77.1 ± 9.5, 131 men) underwent endovascular revascularization. Technical success rate was 95.2%, 92.5%, and 100% in patients without, moderate or severe RI. Sustained clinical success was 81.7%, 74.1%, and 51.5% in patients with normal renal function, 87.8%, 67.0%, and 63.3% with moderate, and 81.0%, 64.6%, and 50.2% with severe RI (P = .87 by log-rank) at 2, 6, and 12 months. Accordingly, major amputation rates were 9.9%, 18.2%, and 20.8% vs 9.9%, 22.6%, and 24% vs 12.5%, 16.7%, and 21.1% (P = .83, by log-rank). Mortality rates were 8.4%, 17.6%, and 26.5% in patients with normal renal function, 9.6%, 17.6%, and 30.1% with moderate and 17.5%, 26.6%, and 31.9% in patients with severe RI (P = .77, by log-rank) at corresponding intervals. Multivariate analysis revealed eGFR (hazard ratio [HR], 1.016; 95% confidence interval [CI], 1.001-1.031; P = .036), age (HR, 1.12; 95% CI, 1.061-1.189; P < .0001) and cigarette smoking (HR, 3.14; 95% CI, 1.153-8.55; P = .026) to be predictors for increased mortality within 1 year of follow-up.
While functional lower limb outcomes were not influenced by renal function in this study, presence of RI was an independent predictor for higher mortality in CLI patients undergoing endovascular revascularization.
尽管有关临床结果的信息很少，但患有肾功能不全（RI）的患者在严重肢体缺血（CLI）的各种血管内血运重建概念的试验中经常被排除在外。
在一家三级转诊中心，连续对在 4.5 年时间间隔内接受下肢血管内血运重建的 CLI 患者进行前瞻性随访，随访时间为 12 个月。根据定义的肾功能将患者分为以下几组：正常组（估计肾小球滤过率[eGFR]≥60 mL/min/1.73 m2；n=108，49.5%）、中度 RI 组（eGFR≥30-59 mL/min/1.73 m2；n=86，39.5%）和严重 RI 组，包括透析（eGFR<30 mL/min/1.73 m2；n=24，11%）。评估的临床终点包括持续临床成功、围手术期和术后死亡率以及主要的、踝上截肢。持续临床改善定义为与基线相比，Rutherford 分类至少上升一个等级，达到无跛行的水平，无需再次血管重建或幸存患者的计划性截肢。使用 Kaplan-Meier 方法进行生存分析。分别在单独的模型中对所有上述临床终点进行多变量回归分析。
共有 208 名患者（218 条肢体，平均年龄 77.1±9.5 岁，131 名男性）接受了血管内血运重建。无 RI、中度 RI 和严重 RI 患者的技术成功率分别为 95.2%、92.5%和 100%。在肾功能正常的患者中，持续临床成功率为 81.7%、74.1%和 51.5%，在中度 RI 患者中为 87.8%、67.0%和 63.3%，在严重 RI 患者中为 81.0%、64.6%和 50.2%（P=0.87 对数秩检验），在 2、6 和 12 个月时。相应地，主要截肢率分别为 9.9%、18.2%和 20.8%，9.9%、22.6%和 24%，12.5%、16.7%和 21.1%（P=0.83，对数秩检验）。肾功能正常的患者死亡率分别为 8.4%、17.6%和 26.5%，中度 RI 患者分别为 9.6%、17.6%和 30.1%，严重 RI 患者分别为 17.5%、26.6%和 31.9%（P=0.77，对数秩检验）。多变量分析显示 eGFR（风险比[HR]，1.016；95%置信区间[CI]，1.001-1.031；P=0.036）、年龄（HR，1.12；95% CI，1.061-1.189；P<0.0001）和吸烟（HR，3.14；95% CI，1.153-8.55；P=0.026）是 1 年内死亡风险增加的预测因素。
虽然在这项研究中肾功能对下肢功能结果没有影响，但 RI 的存在是 CLI 患者血管内血运重建后死亡率增加的独立预测因素。
