1/2 Women's Aneurysm Research: Repair Immediately Or Routine Surveillance: WARRIORS trial

Project Summary Abdominal Aortic Aneurysm (AAA) repair is typically recommended when the aneurysm diameter reaches 5.5 cm, based on studies that primarily included men. Women, however, face a fourfold higher risk of AAA rupture at smaller diameters and nearly double the mortality following surgery. This discrepancy raises critical questions about whether women should undergo elective AAA repair at smaller diameters than men to improve survival and quality of life. The WARRIORS trial (Women’s Aneurysm Research: Repair Immediately Or Routine Surveillance) is an international, randomized controlled trial designed to address this issue by comparing early elective endovascular aortic repair (EVAR) with routine surveillance in women aged 50+ with small (4.0-5.4 cm) asymptomatic AAAs suitable for EVAR. The trial will enroll 1,112 women globally, including 350 in the United States, with 1:1 randomization stratified by age, country, and aneurysm size. The primary outcome is AAA-related mortality and rupture over five years, while secondary outcomes include quality-adjusted life years (QALYs), operative mortality, loss of EVAR eligibility, and cost-effectiveness. The trial’s innovative design incorporates registry-supported data collection, novel electronic health record screening for patient identification, and extensive patient and community engagement to ensure broad representation and minimal loss to follow-up. The trial meets criteria for NHLBI’s strategic goals and objectives i.e. Objective 3: Investigate factors that account for differences in health among populations. By determining whether women should have different criteria for AAA repair, the WARRIORS trial aims to establish sex-specific clinical guidelines, ultimately advancing health equity and improving outcomes for women with AAAs.