EMPOWER CAD Overview
Shockwave Medical has announced the first all-female clinical trial at TCT 2022, held in Boston, MA. The prospective multi-center registry will focus on the safety and effectiveness of Shockwave’s intravascular lithotripsy (IVL) technology in female patients with symptomatic ischemic heart disease or coronary artery disease (CAD).
Led by co-principal investigators Alexandra Lansky, MD, professor of medicine at the Yale School of Medicine, Columbia University’s Margaret McEntegart, MD, PhD, and Nieves Gonzalo from the Hospital Clinico San Carlos in Madrid, Spain, EMPOWER CAD will address the inequality gap in the treatment of complex calcified coronary lesions.
Need for a New Approach
Historically, female patients are under-represented in clinical trials. Prior research shows that for female patients treatment of severely calcified coronary lesions results in major adverse procedural complications in up to 5% not seen in males, and in the long-term they have higher mortality and significantly worse outcomes compared to treatment of no or mildly calcified lesions.
EMPOWER CAD is the first coronary intervention study to only include female patients, led by prominent interventional cardiologists. The research team will enroll 400 female patients with symptomatic ischemic heart disease at 50 investigational centers in the United States and Europe with three-year follow-up.
“Early retrospective analyses have suggested that coronary IVL can potentially bridge the disparity in clinical outcomes between sexes, however the studies only included a limited number of females with strict inclusion criteria. Information that will be gathered in EMPOWER CAD will be immensely valuable, as it will provide more robust data with longer-term outcomes in a larger, all-comers patient cohort to determine whether coronary IVL should be considered the front-line calcium modification approach in female patients,” said Lansky in a related press release.
- Evaluate longer-term outcomes of high-risk patients with severe coronary artery disease.
- Establish a new standard of care for female patients using novel technology.