目的:在BEST-CLI随机试验中,初始血运重建方法的主要不良肢体事件无生存(MAE-FS)差异显著。BEST-CLI试验代表了临床实践中高度选择的患者亚组,因此,我们在所有来访者的三级护理实践中检查了MAE-FS的终点。
方法:这是一项单中心回顾性研究,接受CLTI技术上成功的腹股沟下血运重建术的独特患者(2011-2021)。男性是严重截肢(经胫骨或以上)或严重的再介入(新的旁路,开放旁路修订,血栓切除术或溶栓)。
结果:在469名受试者中,平均年龄为70岁,34%为女性.特征包括糖尿病(68%),ESRD(16%),WIfI阶段4(44%),GLASS阶段3(62%)和高足动脉钙评分(pMAC;22%)。血运重建指数为自体静脉搭桥(AVB;30%),非自体旁路(NAB;13%)或腔内(ENDO;57%)。男性或死亡的复合终点发生在237(51%),中位时间为189天,从指征血运重建开始。在调整后的Cox模型中,与男性或死亡独立相关的因素包括年龄较小,ESRD,WIfI阶段4,更高的GLASS阶段,和中度-重度pMAC,而AVB与改善的MALE-FS相关。来自MALE-FS的自由,30天的男性和严重截肢率是90%,92%和95%;一年时分别为63%,70%和83%,分别。男性发生在144(31%),与ESRD相关,在舞台上,玻璃阶段,pMAC评分和索引血运重建方法。AVB具有优越的耐久性,调整后的2年男性自由度为72%,相比之下,ENDO为66%,NAB为51%。在AVB组中,与单段静脉相比,拼接静脉导管的男性较高[HR1.8(95%CI:0.9-3.7);IPW后p=0.008],但大截肢没有统计学上的显著差异。在144名男性患者中,第一位男性为47%的患者进行重大再干预,53%的患者进行重大截肢.首次截肢与非AVB指数方法相关。主要再干预的适应症是症状性狭窄/闭塞(54%),缺乏临床改善(28%),无症状性移植物狭窄(16%)和医源性事件(3%)。在6%的ENDO病例后发生了旁路转换,其中三分之二涉及脚踝或足部的远端旁路目标。
结论:在此连续的,所有来者队列,疾病复杂性与程序选择和MAE-FS相关.AVB独立提供了最大的MALE-FS和免于MALE和重大截肢的自由。与BEST-CLI随机试验相比,在本系列中,ENDO之后的男性更经常是严重截肢,相对较少的转换为开放旁路。
OBJECTIVE: Major adverse limb event-free survival (MALE-FS) differed significantly by initial revascularization approach in the BEST-CLI randomized
trial. The BEST-CLI
trial represented a highly selected subgroup of patients seen in clinical practice; thus, we examined the endpoint of MALE-FS in an all-comers tertiary care practice setting.
METHODS: This is a single-center retrospective
study of consecutive, unique patients who underwent technically successful infrainguinal revascularization for chronic limb-threatening ischemia (2011-2021). MALE was major amputation (transtibial or above) or major reintervention (new bypass, open bypass revision, thrombectomy, or thrombolysis).
RESULTS: Among 469 subjects, the mean age was 70 years, and 34% were female. Characteristics included diabetes (68%), end-stage renal disease (ESRD) (16%), Wound, Ischemia, and foot Infection (WIfI) stage 4 (44%), Global Limb Anatomic Staging System (GLASS) stage 3 (62%), and high pedal artery calcium score (pMAC) (22%). Index revascularization was autogenous vein bypass (AVB) (30%), non-autogenous bypass (NAB) (13%), or endovascular (ENDO) (57%). The composite endpoint of MALE or death occurred in 237 patients (51%) at a median time of 189 days from index revascularization. In an adjusted Cox model, factors independently associated with MALE or death included younger age, ESRD, WIfI stage 4, higher GLASS stage, and moderate-severe pMAC, whereas AVB was associated with improved MALE-FS. Freedom from MALE-FS, MALE, and major amputation at 30 days were 90%, 92%, and 95%; and at 1 year were 63%, 70%, and 83%, respectively. MALE occurred in 144 patients (31%) and was associated with ESRD, WIfI stage, GLASS stage, pMAC score, and index revascularization approach. AVB had superior durability, with adjusted 2-year freedom from MALE of 72%, compared with 66% for ENDO and 51% for NAB. Within the AVB group, spliced vein conduit had higher MALE compared with single-segment vein (hazard ratio, 1.8; 95% confidence interval, 0.9-3.7; P = .008 after inverse propensity weighting), but there was no statistically significant difference in major amputation. Of the 144 patients with any MALE, the first MALE was major reintervention in 47% and major amputation in 53%. Major amputation as first MALE was associated with non-AVB index approach. Indications for major reintervention were symptomatic stenosis/occlusion (54%), lack of clinical improvement (28%), asymptomatic graft stenosis (16%), and iatrogenic events (3%). Conversion to bypass occurred after 6% of ENDO cases, two-thirds of which involved distal bypass targets at the ankle or foot.
CONCLUSIONS: In this consecutive, all-comers cohort, disease complexity was associated with procedural selection and MALE-FS. AVB independently provided the greatest MALE-FS and freedom from MALE and major amputation. Compared with the BEST-CLI randomized
trial, MALE after ENDO in this series was more frequently major amputation, with relatively few conversions to open bypass.