This month a multinational collaboration of researchers received endorsement from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative for the WARRIORS (Women’s abdominal aortic aneurysm research: repair immediately or routine surveillance) trial.
The trial aims to answer the question, should women have their aneurysms repaired electively using endovascular aneurysm repair (EVAR) at smaller diameters than men to improve their survival and quality of life? Imperial College London (London, UK) is co-ordinating the study that will include collaboration with vascular surgeons from Canada, Denmark, The Netherlands, Sweden and the USA. The researchers mention that new partners such as Australia may also be joining.
The investigators note in a press release that the rationale and need for this trial, which seeks to recruit nearly 1,200 women, stems from the poor outcomes suffered by women with abdominal aortic aneurysm (AAA). Although women contribute 15–20% of total AAA burden, and one-third of ruptures, they have been significantly under-represented in trials which guide current AAA repair, the investigators detail, adding that women have smaller arteries, a four-fold higher rupture risk and lose eligibility for EVAR at smaller AAA diameters. Treated at the current threshold, the researchers note that a greater proportion receive either higher-risk open surgery or no repair at all. Those that do receive elective repair, do worse, with nearly double the rate of operative mortality (open surgery 6%, endovascular aneurysm repair [EVAR] 2.3%), higher postoperative complication rates and longer hospital stays.
“We have learnt that women worry a lot about their AAA and modelling has suggested that repair of AAA at 4cm for women might result in improved quality of life and reduced overall cost,” the investigators write. “These potential benefits as well as reduction in aneurysm-related mortality, would need to be balanced against the operative risk of early repair.” They state that these areas of uncertainty, regarding the optimal strategy for AAA repair in women, are what the trial seeks to answer.
The endorsement provided by the GCRFF allows the investigators to move forward and seek priority funding from their partner organisations. The team is also hoping for some support from industry for specific aspects of the trial and/or associated registry.
According to the investigators, WARRIORS would be the first randomised trial of AAA management with multinational, wide-ranging, expertise and to have received endorsement from the GCRFF. However, they stress that this is the just the first step. They elaborate: “To gain funding within each participating country and to implement the trial successfully we will need considerable support from the vascular and multidisciplinary community. The disadvantage of women with AAA can no longer be ignored, and we hope that you will support us, in what will hopefully be a major step towards readdressing the imbalance in AAA outcomes for women and men. We also hope that this initiative will pave the way to obtain evidence about the management of other underserved patient groups, minorities and rarer diseases managed by vascular surgeons.”
To find out more, or be put in touch with your country team, please contact the WARRIORS investigators at Imperial College London—Colin Bicknell, Anna Pouncey and Janet Powell—at [email protected]