1 Department of Vascular Surgery, St Franziskus Hospital GmbH, Münster, Germany.
2 Department of Vascular Surgery, University Clinic of Münster, Germany.
J Endovasc Ther. 2018 Jun;25(3):320-329. doi: 10.1177/1526602818771383. Epub 2018 Apr 26.
To examine the outcomes of all first-line strategies for the treatment of critical limb ischemia (CLI), identify factors that influenced the treatment choice, and determine the risk of amputation or death after each treatment.
CRITISCH ( ClinicalTrials.gov identifier NCT01877252) is a multicenter, national, prospective registry evaluating all available treatment strategies applied in 1200 consecutive CLI patients in 27 vascular centers in Germany. The recruitment started in January 2013 and was completed in September 2014. Treatment options were endovascular revascularization (642, 53.5%), bypass surgery (284, 23.7%), femoral artery patchplasty (126, 10.5%) with or without concomitant peripheral intervention, conservative treatment (118, 9.8%), and primary major amputation (30, 2.5%). The primary endpoint of this study was amputation-free survival (AFS). The Society of Vascular Surgery's suggested objective performance goal (OPG) for AFS (71%) was used as the effectiveness criterion. Multivariable regression methods were employed to identify variables that influenced the treatment selection and AFS after each treatment; results are presented as the hazard ratio (HR) and 95% confidence interval (CI).
The 12-month AFS estimates following endovascular therapy, bypass grafting, femoral patchplasty, and conservative treatment were 75%, 72%, 73%, and 72%, respectively. Factors influencing treatment choice were age, chronic kidney disease (CKD), diabetes, smoking, prior vascular procedures in the index leg, TransAtlantic Inter-Society Consensus II C/D lesions, and absence of runoff vessels. Cox regression analysis identified CKD (HR 2.07, 95% CI 1.26 to 3.41, p=0.004), the use of a prosthetic bypass conduit (HR 1.97, 95% CI 1.23 to 3.14, p=0.004), and previous vascular intervention in the index limb (HR 1.52, 95% CI 0.94 to 2.43, p=0.085) as independent risk factors for diminished AFS after bypass surgery. CKD (HR 1.47, 95% CI 1.09 to 1.99, p=0.012) and Rutherford category 6 (HR 1.81, 95% CI 1.30 to 2.52, p<0.001) compromised the performance of endovascular revascularization.
CRITISCH registry data revealed that all first-line treatment strategies selected and indicated by the treating physicians met the suggested OPGs. CKD was an important determinant of patient prognosis after treatment regardless of the revascularization method.
研究治疗严重肢体缺血（CLI）的一线治疗策略的结果，确定影响治疗选择的因素，并确定每种治疗后的截肢或死亡风险。
CRITISCH（ClinicalTrials.gov 标识符 NCT01877252）是一项多中心、全国性、前瞻性登记研究，评估了德国 27 个血管中心的 1200 例连续 CLI 患者中所有可用的治疗策略。招募工作于 2013 年 1 月开始，于 2014 年 9 月完成。治疗方案包括腔内血管重建术（642 例，占 53.5%）、旁路手术（284 例，占 23.7%）、股动脉修补术（126 例，占 10.5%），同时伴有或不伴有外周介入治疗、保守治疗（118 例，占 9.8%）和一期主要截肢（30 例，占 2.5%）。本研究的主要终点是无截肢生存率（AFS）。采用血管外科学会建议的 AFS（71%）作为有效性标准。采用多变量回归方法确定影响治疗选择和每种治疗后 AFS 的变量；结果表示为风险比（HR）和 95%置信区间（CI）。
腔内治疗、旁路移植术、股动脉修补术和保守治疗 12 个月的 AFS 估计值分别为 75%、72%、73%和 72%。影响治疗选择的因素包括年龄、慢性肾脏病（CKD）、糖尿病、吸烟、索引肢体的既往血管手术、跨大西洋内科学会共识 II C/D 病变以及无流出血管。Cox 回归分析确定 CKD（HR 2.07，95%CI 1.26 至 3.41，p=0.004）、使用人造旁路移植物（HR 1.97，95%CI 1.23 至 3.14，p=0.004）和索引肢体的既往血管介入治疗（HR 1.52，95%CI 0.94 至 2.43，p=0.085）是旁路手术后 AFS 降低的独立危险因素。CKD（HR 1.47，95%CI 1.09 至 1.99，p=0.012）和 Rutherford 分类 6（HR 1.81，95%CI 1.30 至 2.52，p<0.001）降低了腔内血管重建的效果。
CRITISCH 登记研究数据显示，治疗医生选择和指示的所有一线治疗策略均符合建议的 OPG。无论采用何种血管重建方法，CKD 都是影响治疗后患者预后的重要决定因素。
