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September 9, 2022
WARRIORS Randomized Trial Will Aim to Examine Early EVAR in Women
September 9, 2022—Investigators for the multinational WARRIORS trial (“Women’s Abdominal Aortic Aneurysm [AAA] Research: Repair Immediately or Routine Surveillance”) announced that the trial received endorsement from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative.
According to the investigators, the GCRFF endorsement allows them to move forward and seek priority funding from their partner organizations. The investigators also hope for support from industry for specific aspects of the trial and/or associated registry.
The WARRIORS trial aims to determine if women should 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 in the United Kingdom is coordinating the efforts for the trial that will include collaboration with vascular surgeons from Canada, Denmark, Germany, the Netherlands, Sweden, and the United States. New partners such as Australia may be joining the international collaboration that seeks to recruit approximately 1,200 women in a short period of time.
Interested parties seeking to be put in touch with their countries’ teams or to learn more about the trial should contact the WARRIORS investigators at Imperial College—Colin Bicknell, MD; Anna Pouncey, MD; and Janet Powell, MD—at warriors@imperial.ac.uk.
According to the investigators, the rationale and need for this trial stems from the poor outcomes experienced by women with AAA. They noted that women account for 15% to 20% of total AAA burden, and one-third of ruptures, but they have been significantly underrepresented in trials that guide current AAA repair. Additionally, women have smaller arteries, a fourfold higher rupture risk, and lose eligibility for EVAR at smaller AAA diameters.
Treated at the current threshold, a greater proportion of women than men receive either higher-risk open surgery or no repair at all. Those women that do receive elective repair have worse outcomes with approximately double the rate of operative mortality (open surgery, 6%; EVAR, 2.3%), higher postoperative complication rates, and longer hospital stays.
In the announcement, the investigators stated:
“We have learned that women worry a lot about their AAA and modeling has suggested that repair of AAA at 4 cm for women might result in improved quality of life and reduced overall cost. These potential benefits as well as reduction in aneurysm-related mortality, would need to be balanced against the operative risk of early repair. These areas of uncertainty, regarding the optimal strategy for AAA repair in women, are what the trial seeks to answer.
“WARRIORS would be the first randomized trial of AAA management with multinational, wide-ranging expertise and to have received endorsement from the GCRFF.
"However, this is just the first step.
“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 [the community] 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.”
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