在 Bypass vs. Angioplasty in Severe Ischaemia of the Leg（BASIL-1）试验中，比较慢性肢体威胁性缺血患者血管重建治疗中男性和女性的即刻和长期结局。
Comparison of Immediate and Long-term Outcomes in Men and Women Undergoing Revascularisation for Chronic Limb Threatening Ischaemia in the Bypass vs. Angioplasty in Severe Ischaemia of the Leg (BASIL-1) Trial.
机构信息
Department of Vascular Surgery and Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK; Department of Vascular Surgery, University Hospital Coventry and Warwickshire, UK.
Department of Vascular Surgery and Birmingham Clinical Trials Unit, University of Birmingham, Birmingham, UK.
出版信息
Eur J Vasc Endovasc Surg. 2019 Aug;58(2):224-228. doi: 10.1016/j.ejvs.2019.03.001. Epub 2019 Jun 12.
BACKGROUND
The reports from cohort studies comparing outcomes after revascularisation for chronic limb threatening ischaemia (CLTI) between men and women remain controversial. Anatomical and clinical disease severity is often heterogeneous, and treatment choice influenced by a variety of clinician and patient factors. The aim was to compare outcomes in men and women entered into the only randomised study comparing bypass and angioplasty for infra-inguinal disease causing severe limb ischaemia.
METHODS
Data were obtained from BASIL-1 trial case record forms. Baseline demographics were compared, and Cox proportional hazard models were used to examine the relationship between sex and amputation free survival (AFS), overall survival (OS), and freedom from major adverse limb events (FF-MALE) using a per-protocol analysis. Data were analysed using a per-protocol analysis.
RESULTS
A total of 452 patients were randomised into the BASIL-1 trial from 1999 to 2004. At randomisation, women were older and less likely to be smokers, to have diabetes, or to be on recommended best medical therapy. Men were more likely to present with gangrene. Ankle brachial pressure index (ABPI), post-revascularisation length of hospital stay, and 30 day morbidity and mortality were similar for men and women. At three years, female sex was associated with significantly better AFS (HR 0.65, 95% CI 0.47-0.89, p < .01), OS (HR 0.66 95% CI 0.46-0.95, p = .02) and FF-MALE (HR 0.74, 95% CI 0.57-0.96, p = .02).
CONCLUSION
In the BASIL-1 trial, women had similar short term but better long term outcomes after revascularisation. Sex is an important consideration when developing early, evidence based treatment pathway and revascularisation strategies for CLTI, and is an independent risk factor for outcomes following revascularisation as well as development of symptomatic PAD.
背景
比较慢性肢体威胁性缺血（CLTI）男性和女性血管重建术后结局的队列研究报告仍然存在争议。解剖学和临床疾病严重程度通常是异质的，治疗选择受到多种临床医生和患者因素的影响。目的是比较仅有的一项比较旁路和血管成形术治疗导致严重肢体缺血的下肢疾病的随机研究中男性和女性的结局。
方法
从 BASIL-1 试验病例报告表中获取数据。比较基线人口统计学特征，并使用 Cox 比例风险模型，使用意向治疗分析，检查性别与免于截肢的生存（AFS）、总生存（OS）和免于主要不良肢体事件（FF-MALE）之间的关系。使用意向治疗分析进行数据分析。
结果
1999 年至 2004 年，共有 452 名患者被随机分配到 BASIL-1 试验中。在随机分组时，女性年龄较大，不太可能吸烟、患有糖尿病或接受推荐的最佳药物治疗。男性更可能出现坏疽。踝肱血压指数（ABPI）、血管重建术后住院时间、30 天发病率和死亡率在男性和女性之间相似。在 3 年时，女性性别与更好的 AFS（HR 0.65，95%CI 0.47-0.89，p<0.01）、OS（HR 0.66 95%CI 0.46-0.95，p=0.02）和 FF-MALE（HR 0.74，95%CI 0.57-0.96，p=0.02）显著相关。
结论
在 BASIL-1 试验中，女性血管重建术后短期结果相似，但长期结果更好。在制定早期、基于证据的治疗途径和 CLTI 血管重建策略时，性别是一个重要的考虑因素，并且是血管重建后结局以及症状性 PAD 发展的独立危险因素。
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