Shockwave Initiates All-Female EMPOWER CAD Coronary IVL Study

September 19, 2022—Shockwave Medical, Inc. announced that the company has initiated EMPOWER CAD, a coronary artery disease (CAD) intervention study consisting of all female patients to determine whether the positive results from earlier coronary studies of intravascular lithotripsy (IVL) with the Shockwave C² coronary IVL catheter (which showed similar safety outcomes across both sexes) can be replicated in an expanded, real-world population of female patients with severely calcified coronary lesions.

The prospective, multicenter registry will enroll up to 400 female patients with symptomatic ischemic heart disease in up to 50 investigational centers in the United States and Europe with 3-year follow-up.

EMPOWER CAD coprincipal investigators Margaret McEntegart, MD, PhD, and Alexandra Lansky, MD, with the study’s European lead investigator, Nieves Gonzalo, MD, PhD, announced the study at TCT 2022, the 34th annual Transcatheter Cardiovascular Therapeutics scientific symposium of the Cardiovascular Research Foundation held September 16-19 in Boston, Massachusetts.

Dr. McEntegart is Director of Complex Percutaneous Coronary Intervention Program at Columbia University Medical Center/New York-Presbyterian Hospital in New York, New York. Dr. Lansky is Professor of Medicine, Section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine in New Haven, Connecticut. Dr. Gonzalo is Consultant Interventional Cardiologist at Hospital Clinico San Carlos in Madrid, Spain.

“When it comes to CAD, females are often under-investigated, undertreated, and have less favorable outcomes than males due to a variety of different factors,” commented Dr. McEntegart in Shockwave’s press release. “Previous reports with atherectomy have shown that females with calcified CAD are more susceptible to adverse procedural outcomes compared to males.”

Dr. McEntegart continued, “Despite often being more challenging to treat, female patients are underrepresented in published data, and there have been no dedicated prospective studies performed on this population. EMPOWER CAD will be an extremely valuable study to better inform interventional cardiologists on the optimal treatment strategy for these complex patients.”

Dr. Lansky added, “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.”