Houghton John S M, Meffen Anna, Gray Laura J, Payne Tanya J, Haunton Victoria J, Davies Robert S M, Sayers Rob D
Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; Leicester Vascular Institute, University Hospitals of Leicester NHS Trust, Leicester, UK; National Institute for Health Research Leicester Biomedical Research Centre - The Glenfield Hospital, Leicester, UK.
Department of Cardiovascular Sciences, University of Leicester, Leicester, UK; Department of Population Health Sciences, University of Leicester, Leicester, UK.
Eur J Vasc Endovasc Surg. 2025 Mar;69(3):465-473. doi: 10.1016/j.ejvs.2024.09.005. Epub 2024 Sep 10.
Patient characteristics and patterns of disease in chronic limb threatening ischaemia (CLTI) have markedly changed in recent years. Urgent specialist referral and timely revascularisation are recommended in international guidelines. UK guidelines now recommend revascularisation within five days of referral for inpatients and two weeks in outpatients. This study compared the contemporary one year major amputation incidence in patients with CLTI with a historical cohort at a single UK centre.
This was a single centre, observational cohort study with historical controls. A prospective cohort was recruited between May 2019 and March 2022. A historical cohort presenting between 2013 and 2015 inclusive was retrospectively identified. Significant changes in management pathways, including establishing a rapid access limb salvage clinic, occurred between these periods, aiming to expedite time from referral to revascularisation. The one year primary outcome was major amputation, and the secondary outcome was death. Major amputation was analysed by Fine-Gray competing risks models (death as the competing risk), presented as subdistribution hazard ratios (SHRs). One year mortality was analysed by Cox regression, presented as hazard ratios. Analyses were adjusted for propensity score.
A total of 928 patients were included (432 prospective and 496 historical). Proportions of patients presenting with tissue loss (72.2% vs. 71.6%; p = .090) were similar in both cohorts. At one year, 48 patients (11.1%) in the prospective cohort and 124 patients (25.0%) in the historical cohort had undergone a major amputation (p < .001). Risk of major amputation was 57.0% lower in the prospective cohort compared with the historical cohort after adjustment for propensity score (SHR 0.43, 95% confidence interval 0.29 - 0.63; p < .001).
An encouraging reduction in major amputation incidence was observed after improvements to CLTI management pathways, but residual confounding is likely. The generalisability of these results is uncertain.
近年来，慢性肢体威胁性缺血（CLTI）患者的特征和疾病模式发生了显著变化。国际指南建议进行紧急专科转诊并及时进行血运重建。英国指南现建议住院患者在转诊后五天内进行血运重建，门诊患者在两周内进行。本研究比较了英国一家中心CLTI患者的当代一年期大截肢发生率与一个历史队列。
这是一项采用历史对照的单中心观察性队列研究。在2019年5月至2022年3月期间招募了一个前瞻性队列。回顾性确定了一个在2013年至2015年（含）期间就诊的历史队列。在这些时期之间，管理途径发生了重大变化，包括设立了一个快速通道肢体挽救诊所，旨在加快从转诊到血运重建的时间。一年期主要结局是大截肢，次要结局是死亡。大截肢采用Fine-Gray竞争风险模型进行分析（将死亡作为竞争风险），以亚分布风险比（SHR）表示。一年期死亡率采用Cox回归分析，以风险比表示。分析对倾向得分进行了调整。
共纳入928例患者（432例前瞻性患者和496例历史队列患者）。两个队列中出现组织损失的患者比例相似（72.2%对71.6%；p = 0.090）。一年时，前瞻性队列中有48例患者（11.1%）进行了大截肢，历史队列中有124例患者（25.0%）进行了大截肢（p < 0.001）。在对倾向得分进行调整后，前瞻性队列中大截肢的风险比历史队列低57.0%（SHR 0.43，95%置信区间0.29 - 0.63；p < 0.001）。
在CLTI管理途径得到改善后，观察到令人鼓舞的大截肢发生率降低，但可能存在残余混杂因素。这些结果的可推广性尚不确定。
