Kansai Rosai Hospital Cardiovascular Center, Inabaso, Amagasaki, Hyogo, Japan.
J Vasc Surg. 2013 Apr;57(4):974-981.e1. doi: 10.1016/j.jvs.2012.10.096. Epub 2013 Feb 1.
Prognosis of endovascular therapy (EVT) for isolated infrapopliteal lesions has not been adequately studied. We investigated and risk-stratified long-term prognosis after EVT for critical limb ischemia (CLI) attributable to isolated infrapopliteal lesions.
Between March 2004 and October 2010, 884 patients (1057 limbs) with CLI attributable to isolated infrapopliteal lesions who underwent EVT with angioplasty alone were enrolled. Outcome measures were freedom from major adverse limb events with perioperative death (MALE+POD) and amputation-free survival. Cox proportional hazards models were used to assess independent predictors for these outcomes.
Freedom from MALE+POD was 82 ± 1% and 74 ± 2% at 1 and 5 years, respectively. Risk factors associated with MALE+POD were age ≥80 years (adjusted hazard ratio [HR], 0.4; P < .001), nonambulatory status (HR, 2.0; P < .001), albumin <3.0 g/dL (HR, 1.4; P < .0001), Rutherford 6 (HR, 2.2; P < .001), C-reactive protein ≥3.0 mg/dL (HR, 2.1; P < .001), and below-the-ankle disease (HR, 2.0; P < .001). One- and 5-year amputation-free survival was 71 ± 2% and 38 ± 3%, respectively. Risk factors associated with major amputation/mortality were nonambulatory status (adjusted HR, 2.1; P < .001), body mass index <18.5 kg/m(2) (HR, 1.4; P = .02), albumin <3.0 g/dL (HR, 1.8; P < .0001), end-stage renal disease (HR, 1.4; P = .004), ejection fraction <50% (HR, 1.6; P < .001), Rutherford 6 (HR, 1.9; P < .001), C-reactive protein ≥3.0 mg/dL (HR, 1.7; P < .0001), and below-the-ankle disease (HR, 1.8; P < .001). In patients with more than four risk factors, both end points at 1 year were below the 71% suggested efficacy objective performance goal.
Long-term clinical outcomes were acceptable after EVT for patients with CLI due to pure isolated infrapopliteal lesion. Risk stratification by baseline characteristics is useful in estimating long-term prognosis.
孤立性腘下病变腔内治疗（EVT）的预后尚未得到充分研究。我们调查并对因孤立性腘下病变导致的严重肢体缺血（CLI）行 EVT 后的长期预后进行风险分层。
2004 年 3 月至 2010 年 10 月，884 例（1057 条肢体）CLI 归因于孤立性腘下病变且仅行血管成形术 EVT 的患者被纳入研究。主要终点是围手术期死亡（MALE+POD）和免于截肢的复合终点事件。采用 Cox 比例风险模型评估这些结果的独立预测因素。
MALE+POD 无事件生存率分别为术后 1 年时 82±1%和术后 5 年时 74±2%。与 MALE+POD 相关的风险因素包括年龄≥80 岁（调整后的风险比[HR]，0.4；P＜0.001）、非卧床状态（HR，2.0；P＜0.001）、白蛋白＜3.0g/dL（HR，1.4；P＜0.0001）、Rutherford 分级 6 级（HR，2.2；P＜0.001）、C-反应蛋白≥3.0mg/dL（HR，2.1；P＜0.001）和踝下病变（HR，2.0；P＜0.001）。1 年和 5 年的免于截肢的生存率分别为 71±2%和 38±3%。与大截肢/死亡率相关的风险因素包括非卧床状态（调整后的 HR，2.1；P＜0.001）、体质指数＜18.5kg/m²（HR，1.4；P=0.02）、白蛋白＜3.0g/dL（HR，1.8；P＜0.0001）、终末期肾病（HR，1.4；P=0.004）、射血分数＜50%（HR，1.6；P＜0.001）、Rutherford 分级 6 级（HR，1.9；P＜0.001）、C-反应蛋白≥3.0mg/dL（HR，1.7；P＜0.0001）和踝下病变（HR，1.8；P＜0.001）。在具有超过四个危险因素的患者中，1 年时的两个终点均低于 71%的建议疗效目标。
因孤立性腘下病变导致 CLI 患者行 EVT 后，长期临床结局是可以接受的。通过基线特征进行风险分层有助于预测长期预后。
