University Department of Vascular Surgery, Heart of England NHS Foundation Trust, Birmingham, United Kingdom.
University Department of Vascular Surgery, Heart of England NHS Foundation Trust, Birmingham, United Kingdom.
J Vasc Surg. 2019 Jun;69(6):1840-1847. doi: 10.1016/j.jvs.2018.08.197. Epub 2019 Mar 7.
Bypass surgery (BS) remains the gold standard revascularization strategy in patients with chronic limb-threatening ischemia (CLTI) owing to infrainguinal disease. The Bypass versus Angioplasty for Severe Ischaemia of the Leg (BASIL)-1 trial showed that, in patients with CLTI who survived for 2 years or more, BS resulted in better clinical outcomes. Despite this finding, there has been an increasing trend toward an endovascular-first approach to infrainguinal CLTI. Our aim was to investigate whether changes in practice have impacted the clinical outcomes of BS in our unit 10 years after BASIL-1.
Data for patients who underwent femoropopliteal (FP) BS in BASIL-1 (1999-2004) were retrieved from trial case record forms. The comparator contemporary series (CS) comprised all patients undergoing FP BS for CLTI in our unit between 2009 and 2014. Demographic and clinical outcome data on patients in the CS were collected from the prospectively collected hospital electronic notes. Anatomic patterns of disease in the BASIL-1 and CS cohorts were scored using the Bollinger and GLASS criteria. Statistical analysis was performed in SAS v9.4.
There were 128 patients from BASIL-1 and 50 patients in the CS. Baseline age, gender, affected limb, and diabetes prevalence were similar, as were days spent in hospital out to 12 months and length of follow-up. BASIL-1 patients were more likely to be current smokers (P = .000) and had a higher creatinine (P = .04). The 30-day morbidity and mortality were higher in BASIL-1 (45.3% vs 22%; P = .004). There was no significant difference between BASIL-1 and CS with regard to run-off Bollinger (37.7 vs 32.1; P = .167) and IP GLASS (0 vs 0; P = .390) scores, with both groups having a median of two runoff vessels. Amputation-free survival (62% vs 28%; hazard ratio [HR], 1.86; 95% confidence interval [CI], 1.18-2.93; P = .007), limb salvage (85% vs 69%; HR, 2.31; 95% CI, 1.14-4.68; P = .02), overall survival (69% vs 35%; HR, 1.66; 95% CI, 1.00-2.74; P = .05) and major adverse limb events (67% vs 47%; HR, 1.93; 95% CI, 1.15-3.22; P = .01) were all significantly better in BASIL-1.
Although 30-day mortality and morbidity were significantly lower, all of the examined longer term clinical outcomes after FP BS were significantly worse in the CS group a decade on from BASIL-1. Further research in the form of prospective cohort studies and randomized controlled trials is urgently required to determine if the CS data reported herein are generalizable to current vascular surgical practice and, if so, to determine the reasons for these unexpected outcomes.
由于下肢慢性缺血性疾病，旁路手术（BS）仍然是慢性肢体威胁性缺血（CLTI）患者的血管重建黄金标准。BASIL-1 试验表明，在 CLTI 患者中，如果患者存活 2 年或更长时间，BS 会带来更好的临床结果。尽管有这一发现，但越来越倾向于采用腔内方法治疗下肢慢性缺血性疾病。我们的目的是研究在 BASIL-1 之后的 10 年，BS 的实践变化是否对我们科室的 BS 临床结果产生了影响。
从 BASIL-1 的试验病例记录中检索了接受股腘旁路手术（FPBS）的患者数据。比较的当代系列（CS）包括我们科室在 2009 年至 2014 年期间对所有接受 FPBS 治疗的 CLTI 患者的数据。CS 患者的人口统计学和临床结果数据从前瞻性收集的医院电子病历中收集。BASIL-1 和 CS 队列的解剖病变模式使用 Bollinger 和 GLASS 标准进行评分。在 SAS v9.4 中进行统计分析。
BASIL-1 组有 128 例患者，CS 组有 50 例患者。基线年龄、性别、受累肢体和糖尿病患病率相似，12 个月内住院天数和随访时间也相似。BASIL-1 患者中目前吸烟者更多（P =.000），肌酐水平更高（P =.04）。BASIL-1 的 30 天发病率和死亡率更高（45.3%比 22%；P =.004）。BASIL-1 和 CS 组在流出道 Bollinger 评分（37.7 比 32.1；P =.167）和 IP GLASS 评分（0 比 0；P =.390）方面没有显著差异，两组的中位流出道血管均为 2 条。无截肢生存率（62%比 28%；风险比[HR]，1.86；95%置信区间[CI]，1.18-2.93；P =.007）、保肢生存率（85%比 69%；HR，2.31；95%CI，1.14-4.68；P =.02）、总生存率（69%比 35%；HR，1.66；95%CI，1.00-2.74；P =.05）和主要不良肢体事件发生率（67%比 47%；HR，1.93；95%CI，1.15-3.22；P =.01）在 BASIL-1 中均显著更好。
尽管 30 天死亡率和发病率明显较低，但在 BASIL-1 之后的 10 年，CS 组所有检查的 FPBS 后长期临床结果均明显较差。迫切需要以前瞻性队列研究和随机对照试验的形式进行进一步研究，以确定本报告的 CS 数据是否可推广到当前的血管外科学实践，如果可以，确定出现这些意外结果的原因。
