Heart disease is the leading cause of death for women in the United States, killing 301,280 women in 2019 – or about one in every five female deaths. More specifically, about one in sixteen women aged 20 and older (6.2%) have coronary artery disease (CAD). While there has been an increase in awareness over the decades, as of February 2022, only 56% of women recognize heart disease as the number one killer it is. Despite awareness, however, data shows that women are under-investigated, under-treated, and have less favorable outcomes compared to men when it comes to coronary artery disease (CAD). Additionally, previous reports with atherectomy have shown that women with calcified CAD are at a higher risk of adverse procedural outcomes. Even so, female patients remain to be under-represented in published data and there have been no dedicated prospective studies performed exclusively on this population.

Shockwave Medical, a company developing intravascular lithotripsy to treat severely calcified cardiovascular disease, today announced it has initiated the first-ever prospective coronary intervention study with only female patients, EMPOWER CAD. The multicenter study hopes to determine whether the positive results from earlier coronary IVL studies treated with the Shockwave C2 Coronary IVL Catheter can be replicated in an expanded, “real-world” population of female patients with severely calcified coronary lesions. This study will try to replicate previous similar safety outcomes across both sexes. The patient population will consist of up to 400 female patients with symptomatic ischemic heart disease in up to 50 investigational centers in the United States and Europe. After the initial testing period, patients will also have a 3-year follow-up.

The company have released early retrospective analyses suggesting coronary IVL can potentially bridge the disparity in female clinical outcomes, but the studies only included a limited number of women 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 Columbia University Medical Center/New York-Presbyterian Hospital employee, Alexandra Lansky, MD, FACC, FAHA, FSCAI, FESC, professor of medicine, section of cardiovascular medicine and director, Heart and Vascular Clinical Research Program at Yale University School of Medicine.

“There is much work that needs to be done to close the female inequality gap in the treatment of complex calcified coronary lesions, and this study represents Shockwave’s commitment to this effort,” said Keith D. Dawkins, MD, chief medical officer of Shockwave Medical. “We hope to enhance the clinical evidence with this new study while also taking the opportunity to work with some of the leading female interventionalists in the community, which will empower future generations of clinical trial investigators.”