This month, a multinational collaboration of researchers received support from the Global Cardiovascular Research Funders Forum (GCRFF) Multinational Clinical Trials Initiative for WARRIORS (Women’s Abdominal Aortic Aneurysm Research: Immediate Repair or Routine Monitoring).
The trial aims to answer the question, should aneurysm repair in women be done electively Internal aneurysm repair (EVAR) With smaller diameters of men to improve their survival and improve their quality of life? Imperial College London (London, UK) is coordinating the study which will involve collaboration with vascular surgeons from Canada, Denmark, the Netherlands, Sweden and the USA and seeks to recruit approximately 1,200 women. The researchers state that new partners such as Australia may also join.
The investigators note in a press release that the rationale and need for this trial stem from the poor outcomes experienced by women with abdominal aortic aneurysms (AAA). Although women contribute 15-20% of the total burden of AAA ruptures, and one-third of ruptures, they were significantly underrepresented in trials guiding current AAA repair, the researchers explained, adding that women had smaller, fourfold higher arteries. Risk of rupture and loss of eligibility for EVAR with diameters smaller than AAA. Treated at the current limit, the researchers note that a larger proportion receive either higher-risk open surgery or no repair at all. Those who receive elective repair perform worse, with approximately twice the surgical mortality (open surgery 6%, endovascular aneurysm repair). [EVAR] 2.3%), higher complication rates after surgery and longer hospital stays.
“We learned that women worry more about AAA,” the investigators wrote, “and modeling has suggested that fixing AAA at 4 cm for women may improve quality of life and reduce overall cost.” “These potential benefits, as well as the reduction in aneurysm-related mortality, must be balanced against the surgical risks of early repair.” They state that these areas of uncertainty, regarding the optimal strategy for repairing AAA expansion in women, are what the trial seeks to answer.
The validation provided by the GCRFF allows investigators to go ahead and seek priority funding from their partner organizations. The team also hopes to gain some industry support for specific aspects of the trial and/or associated enrollment.
According to the investigators, WARRIORS will be the first randomized trial of AAA administration with large-scale, multinational expertise and has received endorsement from the GCRFF. However, they stress that this is only the first step. They explain: “To win funding within each participating country and to successfully implement the trial, we will need significant support from the vascular and multidisciplinary community. The disadvantages of women with AAA can no longer be ignored, and we hope that you will support us, in what we hope will be a major step toward re-addressing the lack of Balance AAA outcomes for women and men. We also hope that this initiative will pave the way for evidence on the management of other underserved patient groups, minorities, and rare diseases managed by vascular surgeons.”
To find out more, or to contact your country team, please contact the Warriors Investigators at Imperial College London – Colin Bicknell, Anna Bounce and Janet Powell – at warriors@im Imperial.ac.uk.