Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 Trial: Analysis of the Timing and Causes of Death in Participants Randomised to an Infrapopliteal Vein Bypass or Best Endovascular Treatment First Revascularisation Strategy.

Autor: Bradbury AW; College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. Electronic address: andrew.bradbury@btinternet.com., Hall J; Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Moakes CA; Birmingham Clinical Trials Unit, Institute of Applied Health Research, University of Birmingham, Birmingham, UK., Popplewell M; College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK., Meecham L; University Hospital of Wales, Cardiff, UK., Bate GR; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Kelly L; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Diamantopoulos A; Guys and St. Thomas NHS Foundation Trust, London, UK., Ganeshan A; University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK., Houlind K; Lillebaelt Hospital, University of Southern Denmark, Denmark., Malmstedt J; Department of Clinical Science and Education, Karolinska Institutet, Stockholm, Sweden; Division of Vascular Surgery, Department of Surgery, Södersjukhuset, Stockholm, Sweden., Patel JV; Leeds Teaching Hospitals NHS Trust, Leeds, UK., Saratzis A; University of Leicester, Leicester, UK., Zayed H; Guys and St. Thomas NHS Foundation Trust, London, UK.
Jazyk: angličtina
Zdroj: European journal of vascular and endovascular surgery : the official journal of the European Society for Vascular Surgery [Eur J Vasc Endovasc Surg] 2024 Jul 26. Date of Electronic Publication: 2024 Jul 26.
DOI: 10.1016/j.ejvs.2024.07.029
Abstrakt: Objective: The Bypass versus Angioplasty in Severe Ischaemia of the Leg (BASIL)-2 trial enrolled participants with chronic limb threatening ischaemia who required an infrapopliteal, with or without a femoropopliteal, revascularisation procedure to restore limb perfusion. Participants randomised to a vein bypass (VB) first revascularisation strategy were over one third more likely than those randomised to a best endovascular treatment (BET) first revascularisation strategy to die from any cause during a median follow up of 40.0 (interquartile range 20.9, 60.6) months. The aim of the present study was to describe the timing and causes of death in BASIL-2 as a first step towards trying to better understand why randomisation to a VB first revascularisation strategy was associated with this excess mortality.
Methods: A 10 person international panel comprising vascular and endovascular surgeons as well as vascular interventional radiologists, who had all been principal investigators in BASIL-2, took part in a modified Delphi consensus exercise to adjudicate the primary cause of death and, in particular, whether the cause was primarily cardiac or non-cardiac.
Results: In 151 of 168 deaths (89.9%), the Delphi panel achieved a consensus regarding the cause of death being probably cardiac or non-cardiac. In the BET group, 16 of 77 deaths (21%) were classified as probably cardiac compared with 32 of 91 (35%) in the VB group (unadjusted subdistribution hazard ratio 2.16, 95% confidence interval [CI] 1.20 - 3.87; unadjusted cause specific hazard ratio 2.15, 95% CI 1.19 - 3.90). At the point of randomisation, 64 of 344 (18.6%), 40 of 342 (11.7%), and 37 of 344 (10.8%) participants had a previous myocardial infarction (MI), percutaneous coronary intervention (PCI), and coronary artery bypass graft (CABG), respectively. There was no evidence of varying treatment effects for cause of death in subgroup analyses of previous PCI, CABG, or MI.
Conclusion: The excess mortality observed in the VB first revascularisation strategy group in BASIL-2 was largely due to deaths that were adjudicated by the Delphi panel as probably primarily cardiac. These excess cardiac deaths were observed throughout follow up and there was no evidence of non-proportional hazards. Further work is ongoing to try to better understand the reasons for these findings.
(Copyright © 2024 The Authors. Published by Elsevier B.V. All rights reserved.)
Databáze: MEDLINE
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