Department of Vascular Surgery, University Hospital Erlangen, Erlangen, Germany.
Department of Medical Informatics, Biometry and Epidemiology, University of Erlangen-Nuremberg, Erlangen, Germany.
J Vasc Surg. 2018 Sep;68(3):822-829.e1. doi: 10.1016/j.jvs.2017.12.048. Epub 2018 Mar 26.
An analysis was conducted of intermediate outcomes and possible influencing factors in patients with end-stage renal disease (ESRD) and critical limb ischemia after lower limb revascularization compared with patients with regular renal function (non-ESRD).
Data collection was performed by inquiry of the German multicenter registry of First-Line Treatments in Patients with Critical Limb Ischemia (CRITISCH); 102 ESRD patients and 674 non-ESRD patients were included. Four different therapy modalities were analysed: bypass surgery, endovascular therapy (EVT), femoral artery endarterectomy, and no vascular intervention (conservative treatment or primary major amputation). Predefined end points were amputation-free survival (AFS), death, major amputation, and reintervention. Cox regression models were built to analyze independent risk factors for outcome parameters.
ESRD patients showed inferior results at 2 years in the rate of AFS (ESRD, 35.4%; non-ESRD, 67.2%; P < .001). Similarly, death rate (ESRD, 55.0%; non-ESRD, 20.7%; P < .001) and major amputation rate (ESRD, 24.5%; non-ESRD, 15.8%; P = .029) were significantly elevated for ESRD patients. The choice of therapeutic approach in ESRD did not influence the incidence of the investigated end points (death or major amputation: EVT, 56.9% vs bypass, 76.9% [P = .225]; death: EVT, 46.2% vs bypass, 61.5% [P = .372]; amputation: EVT, 15.4% vs bypass, 15.4% [P = 1.000]; reintervention: EVT, 32.3% vs bypass, 15.4% [P = .324]). Cox regression analysis indicated that dialysis patients carry a twofold increased hazard of death or major amputation (hazard ratio, 2.27; 95% confidence interval, 1.67-3.10; P < .001), and open surgical treatment (all patients combined) was associated with reduced risk of death compared with EVT (hazard ratio, 0.58; 95% confidence interval, 0.37-0.91; P = .017). Comorbidities were not found to have a noticeable impact on AFS, survival, reintervention, or major amputation.
Two-year AFS, overall survival, and freedom from major amputation were decreased in ESRD patients compared with non-ESRD patients with critical limb ischemia. Cardiovascular comorbidities were without significant impact on outcome parameters, whereas choice of treatment modality within the ESRD group did not influence AFS. Decision-making in ESRD as to choice of therapeutic approach in dialysis patients should notably account for the individual's lesion characteristics and vascular disease; surgical revascularization and EVT may be used as complementary options.
通过对德国下肢血管重建术治疗下肢严重肢体缺血患者的多中心登记研究(CRITISCH)中的终末期肾病(ESRD)患者与肾功能正常(非 ESRD)患者的中期结果和可能的影响因素进行分析。
通过对德国下肢血管重建术治疗下肢严重肢体缺血患者的多中心登记研究(CRITISCH)中的数据进行查询,共纳入 102 例 ESRD 患者和 674 例非 ESRD 患者。分析了四种不同的治疗方式:旁路手术、血管内治疗(EVT)、股动脉内膜切除术和无血管介入(保守治疗或初次大截肢)。预设的终点是无截肢生存率(AFS)、死亡、大截肢和再干预。建立 Cox 回归模型分析结局参数的独立风险因素。
在 2 年时,ESRD 患者的 AFS 率较低(ESRD,35.4%;非 ESRD,67.2%;P<0.001)。同样,ESRD 患者的死亡率(ESRD,55.0%;非 ESRD,20.7%;P<0.001)和大截肢率(ESRD,24.5%;非 ESRD,15.8%;P=0.029)也显著升高。ESRD 患者的治疗方法选择并未影响所调查终点的发生率(死亡或大截肢:EVT,56.9% vs 旁路,76.9%[P=0.225];死亡:EVT,46.2% vs 旁路,61.5%[P=0.372];截肢:EVT,15.4% vs 旁路,15.4%[P=1.000];再干预:EVT,32.3% vs 旁路,15.4%[P=0.324])。Cox 回归分析表明,透析患者的死亡或大截肢风险增加了两倍(危险比,2.27;95%置信区间,1.67-3.10;P<0.001),与 EVT 相比,开放手术治疗(所有患者合并)降低了死亡风险(危险比,0.58;95%置信区间,0.37-0.91;P=0.017)。合并症并未对 AFS、生存、再干预或大截肢产生明显影响。
与非 ESRD 严重肢体缺血患者相比,ESRD 患者的 2 年 AFS、总生存率和免于大截肢的生存率降低。心血管合并症对结局参数没有显著影响,而 ESRD 组内的治疗方式选择并不影响 AFS。在 ESRD 患者中选择治疗方法时,应特别考虑患者的病变特征和血管疾病;手术血管重建和 EVT 可作为互补选择。