The Shockwave study aims to confirm the benefits of coronary intravascular lithotripsy (IVL) in women.
Co-principal investigator Dr. Margaret McEntegart, director of Complex PCI and CTO programs at Columbia University Medical Center/NewYork-Presbyterian Hospital, completed the final enrollment during a live case at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington, D.C. The study, which includes 400 participants across 48 sites in five countries, is set to release primary endpoint results in 2025, with continued patient follow-up through three years.
“The completion of enrollment in EMPOWER CAD is a major milestone in our desire to improve cardiovascular outcomes for women with challenging calcified lesions,” said McEntegart. “Not only will this study yield valuable insights on the performance of coronary IVL in female patients, but as the first prospective all-comers study of coronary IVL, we also hope to gain additional insights about the utility of the technology in more complex patients.”
Women comprise about a quarter of cardiovascular clinical trial participants, limiting gender-specific data essential for treatment advancements. Female patients undergoing PCI face a higher risk of procedural complications, emphasizing the need for targeted studies.
“We are eager to analyze the data and share results next year, with a goal of helping to close the gap in treatment outcomes between men and women,” said Alexandra Lansky, Professor of Medicine, section of Cardiovascular Medicine and Director, Heart and Vascular Clinical Research Program at Yale University School of Medicine and co-principal investigator of EMPOWER CAD. “EMPOWER represents a significant step forward in women’s heart health. We also look forward to seeing the participating female interventional cardiologists and clinical researchers in the study continue to take on clinical trial leadership roles in the years to come.”
Most notably, 71% of enrolling sites are led by female principal investigators.
“We are proud of, and grateful to, all of the dedicated investigators who enrolled this study well ahead of all our expectations, showcasing their commitment to the important issue of women’s cardiovascular care,” Shockwave Medical Chief Medical Officer Nick West said. “This study is a critical step toward closing the gender gap in heart disease treatment, and we recognize the urgent need for clinical data that reflect the unique challenges that women with cardiovascular disease face.”
