Siracuse Jeffrey J, Farber Alik, Menard Matthew T, Rosenfield Kenneth, Conte Michael S, Schanzer Andres, Doros Gheorghe, Motaganahalli Raghu, Laskowski Igor J, Barshes Neal R, Genovese Elizabeth A, Strong Michael B, Mills Joseph L
Division of Vascular and Endovascular Surgery, Department of Surgery, Boston University Chobanian and Avedisian School of Medicine, Boston Medical Center, Boston, MA.
Division of Vascular and Endovascular Surgery, Department of Surgery, Boston University Chobanian and Avedisian School of Medicine, Boston Medical Center, Boston, MA.
J Vasc Surg. 2025 Mar;81(3):720-729.e1. doi: 10.1016/j.jvs.2024.11.027. Epub 2024 Dec 3.
Wound, Ischemia, and foot Infection (WIfI) staging was established to provide objective classification in patients with chronic limb-threatening ischemia (CLTI) and to predict 1-year major amputation risk. Our goal was to validate WIfI staging using data from the Best Endovascular vs Best Surgical Therapy in Patients with CLTI (BEST-CLI) trial.
Data from the BEST-CLI Trial, a prospective randomized trial comparing surgical revascularization (OPEN) and endovascular revascularization (ENDO), were used to assess the association of WIfI stage on long-term outcomes in an intention-to-treat analysis. Patients were prospectively allocated to two cohorts, which included patients with and without adequate single-segment greater saphenous vein, respectively. The primary outcome of this analysis was major amputation.
There were 1568 patients analyzed, representing 86% of the entire trial population; of these 35.5%, 29.6%, and 34.9% were categorized as WIfI stage 4, WIfI stage 3, and WIfI stage 1/2, respectively. There were 1223 patients (606 OPEN, 617 ENDO) and 345 patients (OPEN 172, ENDO 173) in cohorts 1 and 2, respectively. On unadjusted Kaplan-Meier analysis, WIfI clinical stages 4 and 3, compared with WIfI stage 1/2, were associated with higher rates of major amputation (21.4%, 16.2% vs 10.7%), death (33.5%, 35.7% vs 24.6%), amputation/death (44.9%, 44.5% vs 31.3%), major adverse limb events (MALEs)/death (34.4%, 33.9% vs 29.5%), and reintervention/amputation/death (69.9% vs 69% vs 60.4%) (P < .05 for all) at 3 years. On risk-adjusted analysis, compared with WIfI stage 1/2, major amputation was associated with WIfI stage 4 (hazard ratio [HR], 2.06; 95% confidence interval [CI], 1.44-2.96; P < .001) and WIfI stage 3 (HR, 1.62; 95% CI, 1.1-2.37; P = .013) stages. Death was associated with WIfI stage 4 (HR, 1.3; 95% CI, 1.03-1.63; P = .027) and WIfI stage 3 (HR, 1.42; 95% CI, 1.13-1.79; P = .003). MALE/death was associated with WIfI stage 4 (HR, 1.29; 95% CI, 1.02-1.63; P = .036. Reintervention amputation/death was associated with WIfI stage 4 (HR, 1.28; 95% CI, 1.09-1.50; P = .03) and WIfI stage 3 (HR, 1.22, 99% CI 1.03-1.43) ; P = .018). When examining OPEN vs ENDO revascularization by each WIfI stage, OPEN intervention was favored in cohort 1 for MALE/death for each stage.
In BEST-CLI, WIfI stage was strongly associated with major amputations, death, and MALEs/death after revascularization for CLTI. Cohort 1 patients, with an adequate preoperative single segment greater saphenous vein, had lower MALE/death with OPEN intervention across all WIfI stages. This validation of WIfI score in a prospective multicenter trial reinforces its importance in shared-decision making, informed consent, and prognostication.
建立伤口、缺血和足部感染（WIfI）分期系统，旨在为慢性肢体威胁性缺血（CLTI）患者提供客观的分类方法，并预测1年内大截肢风险。我们的目标是利用慢性肢体威胁性缺血患者最佳血管内治疗与最佳手术治疗（BEST-CLI）试验的数据验证WIfI分期。
BEST-CLI试验是一项前瞻性随机试验，比较了外科血管重建术（OPEN）和血管内血管重建术（ENDO）。在一项意向性分析中，我们使用该试验的数据评估WIfI分期与长期预后的相关性。患者被前瞻性地分配到两个队列中，分别包括有和没有足够单段大隐静脉的患者。该分析的主要结局是大截肢。
共分析了1568例患者，占整个试验人群的86%；其中，35.5%、29.6%和34.9%的患者分别被归类为WIfI 4期、WIfI 3期和WIfI 1/2期。队列1中有1223例患者（606例接受OPEN治疗，617例接受ENDO治疗），队列2中有345例患者（172例接受OPEN治疗，173例接受ENDO治疗）。在未调整的Kaplan-Meier分析中，与WIfI 1/2期相比，WIfI临床4期和3期的大截肢率（21.4%、16.2% vs 10.7%）、死亡率（33.5%、35.7% vs 24.6%）、截肢/死亡率（44.9%、44.5% vs 31.3%）、主要不良肢体事件（MALE）/死亡率（34.4%、33.9% vs 29.5%）以及再次干预/截肢/死亡率（69.9% vs 69% vs 60.4%）在3年时均更高（所有P值均<0.05）。在风险调整分析中，与WIfI 1/2期相比，WIfI 4期（风险比[HR]，2.06；95%置信区间[CI]，1.44 - 2.96；P < 0.001）和WIfI 3期（HR，1.62；95% CI，1.1 - 2.37；P = 0.013）与大截肢相关。死亡率与WIfI 4期（HR，1.3；95% CI，1.03 - 1.63；P = 0.027）和WIfI 3期（HR，1.42；95% CI，1.13 - 1.79；P = 0.003）相关。MALE/死亡率与WIfI 4期（HR，1.29；95% CI，1.02 - 1.63；P = 0.036）相关。再次干预截肢/死亡率与WIfI 4期（HR，1.28；95% CI，1.09 - 1.50；P = 0.03）和WIfI 3期（HR，1.22，99% CI 1.03 - 1.43；P = 0.018）相关。在按每个WIfI分期检查OPEN与ENDO血管重建术时，队列1中在每个分期的MALE/死亡率方面，OPEN干预更具优势。
在BEST-CLI试验中，WIfI分期与CLTI血管重建术后的大截肢、死亡和MALE/死亡密切相关。队列1中术前有足够单段大隐静脉的患者，在所有WIfI分期中接受OPEN干预后的MALE/死亡率较低。在一项前瞻性多中心试验中对WIfI评分的验证，强化了其在共同决策、知情同意和预后评估中的重要性。
