The DATA coordinating and Collaborative Research Unit (DATA CRU) at UAB will lead the Data Coordinating Center (DCC) for the United States arm of the international WARRIORS trial (Women’s Aneurysm Research: Repair Immediately Or Routine Surveillance). Adam Beck, M.D., Professor and Director of the Division of Vascular Surgery, and Jeff Szychowski, Ph.D., Professor and Chair of the UAB Department of Biostatistics, will serve as principal investigators for the DCC.
The trial will include 35 healthcare institutions across the United States and will recruit 350 patients into the large international trial. The Clinical Coordinating Center (CCC) in the US is based at Stanford University, where Shipra Arya, M.D., Professor of Vascular Surgery, will serve as principal investigator. At UAB, Associate Professor Emily Spangler, M.D., M.S., will lead site activities at UAB and has received a sub-award from Stanford to guide the trial’s U.S. Community Engagement Panel, which will advise on participant-facing trial materials, recruitment and retention, and dissemination of trial findings.
International oversight of the WARRIORS trial will be provided by vascular surgeons at Imperial College London. The study is funded by multiple European national research organizations and includes investigators from across Europe and Australasia.
About the WARRIORS Clinical Trial
Because women have a lower prevalence of abdominal aortic aneurysm (AAA), they have historically been underrepresented in clinical trials. WARRIORS seeks to address this gap by evaluating whether women with AAA may benefit from earlier intervention rather than routine surveillance, with the goal of preventing rupture and improving outcomes.
“Our division is committed to advancing science and leading initiatives that improve patient care,” says Spangler. “We actively seek opportunities to participate in clinical trials that have the potential to change the standard of care for patients with abdominal aortic aneurysms.”
“The Department of Biostatistics and the DATA CRU are excited to collaborate with Dr. Beck and his exceptional colleagues in the Division of Vascular Surgery to provide data coordination support for the WARRIORS trial. This is an important study with the potential to improve healthcare for women with AAA around the globe,” says Szychowski. “The UAB Data Coordinating Center will create a secure platform for participating institutions to submit high-quality data that will support meaningful research for years to come.”
Participants in the WARRIORS trial are randomized to either surveillance or early minimally invasive intervention to their AAA. The primary objective is to determine whether early endovascular repair is beneficial for women with smaller aneurysm diameters, specifically 4.0 to 5.4 cm.
Patients in the surveillance group will undergo routine clinical monitoring unless the aneurysm enlarges to 5.5 cm or greater, or symptoms develop. Patients in the intervention group will receive early endovascular repair using a minimally invasive device-based approach to reduce AAA-related complications.
Prior AAA studies have enrolled few women due to a higher prevalence of aortic aneurysms in men. However, women face a higher risk of rupture at smaller aneurysm sizes and experience higher mortality following AAA repairs than men. [1] Beck and Spangler are leading advocates within the WARRIORS trial, emphasizing the importance of identifying optimal treatment strategies for women with AAA.
“This trial reflects the strength of UAB’s multidisciplinary clinical trials infrastructure, combining an outstanding clinical team with nationally recognized biostatistics leadership and a proven history of successfully conducting complex, multicenter studies,” says Beck.
UAB’s participation in WARRIORS is funded by the National Institutes of Health, which supports site activities and positions UAB as a key partner for future site selection and data analyses. The NHLBI awarded UAB $1,296,700 over seven years for the DCC, and as a clinical site, Drs. Beck and Spangler, along with their colleagues in the UAB Division of Vascular Surgery will enroll patients into the clinical trial.
In addition to his leadership in WARRIORS, Beck serves as Chair of the Society for Vascular Surgery Vascular Quality Initiative, which monitors outcomes for patients undergoing 14 different vascular procedures including endovascular AAA repair both during their hospital course and with longitudinal follow-up at one year. Szychowski also serves as the Data Coordinating Center Director for multiple randomized clinical trials and follow-up studies focusing on women’s health, including the Chronic Hypertension and Pregnancy (CHAP) project.
References:
1- Sidloff DA, Saratzis A, Sweeting MJ, Michaels J, Powell JT, Thompson SG, Bown MJ. Sex differences in mortality after abdominal aortic aneurysm repair in the UK. Br J Surg. 2017 Nov;104(12):1656-1664. doi: 10.1002/bjs.10600. Epub 2017 Jul 26. PMID: 28745403; PMCID: PMC5655705.