First-of-its-Kind Study Aims to Confirm Benefits of Intravascular Lithotripsy in Women with Calcific Heart Disease.
Shockwave Medical, Inc., part of Johnson & Johnson MedTech, has announced the successful completion of enrollment in EMPOWER CAD, the first prospective study focusing solely on women undergoing coronary interventions for complex calcific disease. The study aims to evaluate the effectiveness of intravascular lithotripsy (IVL) in female patients with calcified lesions, as part of a real-world, post-market analysis.
The enrollment was completed by co-principal investigator Dr. Margaret McEntegart during a live case at the Transcatheter Cardiovascular Therapeutics (TCT) Conference in Washington D.C. Results for the primary endpoint are expected to be presented in 2025, with participants monitored for up to three years.
Dr. McEntegart, who is also the Director of the Complex PCI and CTO programs at Columbia University Medical Center, highlighted the significance of this study. “Completing enrollment in EMPOWER CAD marks a major milestone in our efforts to improve cardiovascular outcomes for women with difficult calcified lesions,” she stated. She expressed hope that the study would provide essential insights into the performance of coronary IVL specifically in female patients and its application in more complex cases.
Historically, women have been underrepresented in cardiovascular clinical trials, making up only about 25% of participants in many studies and 10% of leadership roles in these trials. This lack of representation has resulted in a gap in gender-specific data, which is crucial for enhancing outcomes in coronary artery disease, especially since women face a higher risk of complications during percutaneous coronary interventions (PCI).
Dr. Alexandra Lansky, another co-principal investigator and a professor at Yale University School of Medicine, expressed eagerness to analyze the data from the study. “We aim to share our findings next year to help bridge the treatment outcome gap between men and women,” she said. “EMPOWER is a significant advancement for women’s heart health, and we hope to see more female cardiologists and researchers stepping into leadership roles in future clinical trials.”
The EMPOWER CAD study enrolled 400 participants from 48 sites across five countries, completing enrollment during Dr. McEntegart’s live case presentation. Notably, 71% of the enrolling sites were led by female principal investigators, reflecting the study’s commitment to diversity in clinical research. Dr. Nieves Gonzalo, a consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain, serves as the study’s European lead.
Dr. Nick West, Chief Medical Officer at Shockwave Medical, expressed pride in the investigators involved. “We are thankful to all the dedicated researchers who exceeded our enrollment expectations, demonstrating their commitment to addressing women’s cardiovascular care,” he stated. “This study is crucial for closing the gender gap in heart disease treatment and for gathering clinical data that reflect the specific challenges women face in cardiovascular health.”
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