Department of Clinical and Interventional Angiology, Swiss Cardiovascular Center, Bern University Hospital, Bern, Switzerland.
J Vasc Surg. 2012 Sep;56(3):737-45.e1. doi: 10.1016/j.jvs.2012.02.049. Epub 2012 Jun 6.
Evidence for the best treatment strategy for patients with critical limb ischemia (CLI) at different stages of renal insufficiency (RI) is rare. Therefore, we determined the benefit of revascularization vs medical therapy (MT) only in CLI patients with different levels of RI.
This intention-to-treat cohort study with follow-up at 2, 6, and 12 months was conducted in a consecutive series of 351 patients with CLI. Revascularization by surgical (78 patients) or endovascular techniques (191 patients) was performed in 269 patients. MT as first-line therapy was administered in 82 patients. Patients were grouped according to glomerular filtration rate (GFR), estimated with the Modification of Diet in Renal Disease equation, into absent/mild RI (estimated GFR [eGFR], ≥ 60 mL/min/1.73 m(2)), moderate RI (eGFR, 30-59 mL/min/1.73 m(2)), and severe RI (eGFR, <30 mL/min/1.73 m(2) or dialysis). Primary outcome measures were overall and amputation-free survival. Cox regression models adjusted for baseline characteristics after Kaplan-Meier survival estimates were performed.
The mean age differed significantly between groups (P < .001), and patients with absent/mild RI were more often men (P < .001) or smokers (P < .001) and less often hypertensive (P < .001). Risk factor adjustment showed that revascularized CLI patients with absent/mild RI had a longer amputation-free survival (hazard ratio [HR], 0.46; 95% confidence interval [CI], 0.26-0.82; P = .008), higher limb salvage (HR, 0.29; 95% CI, 0.17-0.91; P < .029), and better clinical success than MT patients (HR, 0.33; 95% CI, 0.17-0.65; P = .001). The moderate RI group benefited from revascularization in overall survival (HR, 0.51; 95% CI, 0.26-0.99; P = .049), amputation-free survival (HR, 0.51; 95% CI, 0.29-0.90; P = .020), and clinical success (HR, 0.42; 95% CI, 0.22-0.80; P = .008). A beneficial effect on overall survival was found even in patients with severe RI when revascularized (HR, 0.33; 95% CI, 0.12-0.91; P = .032 vs MT).
Patients with CLI may benefit from revascularization compared with MT alone at all levels of renal impairment. Thus, revascularization should not be withheld in CLI patients at any level of RI.
对于不同肾功能不全（RI）阶段的临界肢体缺血（CLI）患者，最佳治疗策略的证据很少。因此，我们仅在 CLI 患者中确定了血运重建与药物治疗（MT）的益处，这些患者的 RI 程度不同。
这是一项意向治疗队列研究，在 2、6 和 12 个月进行随访，共纳入 351 例 CLI 患者。269 例患者采用手术（78 例）或血管内技术（191 例）进行血运重建。82 例患者采用 MT 作为一线治疗。根据肾小球滤过率（GFR），使用肾脏病饮食改良公式（Modification of Diet in Renal Disease equation）估计，将患者分为无/轻度 RI（估计肾小球滤过率[eGFR]≥60 mL/min/1.73 m2）、中度 RI（eGFR，30-59 mL/min/1.73 m2）和重度 RI（eGFR＜30 mL/min/1.73 m2 或透析）。主要观察终点为总体生存率和免于截肢生存率。采用 Cox 回归模型，在 Kaplan-Meier 生存估计后对基线特征进行调整。
各组间平均年龄差异显著（P＜0.001），无/轻度 RI 组患者更常为男性（P＜0.001）或吸烟者（P＜0.001），且高血压患者较少（P＜0.001）。危险因素调整后，无/轻度 RI 的 CLI 患者接受血运重建的免于截肢生存率更长（风险比[HR]，0.46；95%置信区间[CI]，0.26-0.82；P=0.008），肢体存活率更高（HR，0.29；95% CI，0.17-0.91；P＜0.029），临床疗效也优于 MT 患者（HR，0.33；95% CI，0.17-0.65；P=0.001）。中度 RI 组在总体生存率（HR，0.51；95% CI，0.26-0.99；P=0.049）、免于截肢生存率（HR，0.51；95% CI，0.29-0.90；P=0.020）和临床疗效（HR，0.42；95% CI，0.22-0.80；P=0.008）方面均从血运重建中获益。即使在严重 RI 患者中，血运重建也可能带来总体生存获益（HR，0.33；95% CI，0.12-0.91；P=0.032 与 MT 相比）。
与单独 MT 相比，CLI 患者在所有肾功能不全程度下可能从血运重建中获益。因此，在任何 RI 水平，都不应拒绝 CLI 患者进行血运重建。
