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

Abstract

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.

Keywords: Angioplasty; Chronic limb threatening ischaemia; Critical limb ischaemia; Infrainguinal bypass; Peripheral vascular disease; Sex.