The National Institutes of Health (NIH) has approved funding for the WARRIORS international randomized trial comparing endovascular aneurysm repair (EVAR) with watchful waiting in women with small abdominal aortic aneurysms (AAAs) measuring 4–5.5 centimeters.
In the United States, the trial will leverage the SVS Vascular Quality Initiative (VQI) endovascular aneurysm repair (EVAR) and vascular medicine registries to collect data at treatment and at one- and five-year follow-ups. Patients will provide consent to the data-coordinating center at the University of Alabama at Birmingham to receive their identified data. This center will oversee site selection, contracts and data queries.
Adam Beck, MD, chair of the SVS Vascular Quality Initiative (VQI) and U.S. principal investigator for the WARRIORS trial, emphasized the importance of both the scientific question and the innovative use of registry infrastructure.
“This trial addresses one of the most important unanswered questions in aortic disease—how best to care for women with small AAAs. Integrating VQI registry data directly into a national and international randomized study allows us to streamline site selection and dramatically enhance data collection efficiency. This model has the potential to accelerate enrollment, reduce cost and fundamentally change how large-scale vascular trials are conducted,” said Beck.
The trial is a study outside of the SVS Patient Safety Organization (PSO) but uses the VQI registries for data collection with SVS PSO permission.
The U.S. arm of the WARRIORS trial plans to enroll 350 patients across 35 sites. Fivos, the SVS PSO’s technology partner, will support registry development, create custom variables and provide training for participating centers. Data will be transmitted quarterly for three years during enrollment and annually for five years of long-term follow-up, for a total project duration of eight years.
The NIH-funded trial is expected to clarify whether early intervention with EVAR offers benefits over surveillance in women with small AAAs—a question with significant implications for clinical practice.
