Elective Abdominal Aortic Aneurysm (AAA) repair is offered when the risk of rupture exceeds the risk of surgery. Women (versus men) have a four-fold higher risk of AAA rupture but almost double the operative mortality. It is unknown whether the current 5.5cm diameter AAA repair threshold, derived from randomised trials including only 4% women, is applicable to women.
Therefore, should women have their aneurysms repaired electively at smaller diameters than men to improve their AAA-related survival and quality of life? WARRIORS is an international randomised controlled trial of early elective endovascular repair versus routine surveillance in women (n=1112) with small asymptomatic AAA (4-5.4cm diameter), nested within a registry of non-participants. The surveillance group will be offered repair for rupture or upon reaching the 5.5cm threshold. Randomisation will be 1:1 stratified by country, age, and aneurysm diameter. The trial is powered for aneurysm-related mortality or rupture at 5 years. Quality-Adjusted-Life-Years is a major secondary outcome. Other outcomes include: operative mortality and complications, anxiety, major cardiovascular adverse events, and cost-effectiveness. Quality-of-life and anxiety questionnaires and "standard-of-care" using routine data will be collected.
The trial aims to progress health equity through provision of evidence for sex-specific clinical guidelines for AAA repair.
female sex
age ≥50 years
infra-renal abdominal aortic aneurysm with a maximum infrarenal aortic anterior-posterior diameter 4.0-5.4 cm, aneurysm, measured on ultrasonography or the centreline orthogonal diameter on Computed Tomography (CT) scan when this is the discovery imaging mode,
Local assessment that arterial morphology is suitable for EVAR within manufacturer's IFU for any licensed infrarenal endograft, including those with concomitant common iliac aneurysm(s), provided the device is landed in the iliac arteries, without coverage of patent internal iliac arteries.
Male sex
aneurysm of the infrarenal aorta of <4.0 or >5.4cm
infrarenal aneurysm not meeting IFU for any specific licensed endograft for standard EVAR
inability to give informed consent
Parallel
EVAR
DeviceCatheter based insertion of aortic endograft via iliac or femoral arteries
Aneurysm-related mortality and rupture
Death caused by the aneurysm or its treatment and non-fatal rupture. Aneurysm-related mortality will include any death within 30 days of AAA repair, death in hospital at beyond 30 days for the index admission for AAA repair and at the same time-points after reinterventions following the index AAA repair, and death from repair or rupture of a supra-renal or iliac aneurysm.
Quality-Adjusted Life Years
Quality of life (from EuroQol 5D-5L questionnaire,, scale 0 to 1, with 1 being best quality of life)) integrated with respect to overall survival.
Anxiety
Anxiety assessed from Hospital Anxiety \& Depression Scale (HADS, 0-21, lowes tscores mean most anxious)) questionnaire
Major Adverse Cardiovascular events
Myocardial infarction, stroke and lower limb amputation
Hospital costs
For aneurysm treatment, (both in-patient and out-patient)
cost-effectiveness
combining data for quality of life (using EuroQol 5D-5L as in outcome 2 above) and hospital treatment costs
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Imperial College London
Lead sponsor
University College, London
Collaborator
University of Leicester
Collaborator
St Georges University Hospital
Collaborator
University of Southern Denmark
Collaborator
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