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Shockwave Medical concludes enrollment in all-female coronary IVL study
Santa Clara: Shockwave Medical, Inc., part of Johnson & Johnson MedTech has announced the completion of enrollment in EMPOWER CAD, the first prospective all-female study of percutaneous coronary intervention (PCI) in complex calcific disease. The study is seeking to confirm the benefits of coronary intravascular lithotripsy (IVL) in female patients with calcified lesions in a post-market, real-world, all-comers population. Primary endpoint results will be presented in 2025, and patients will subsequently be followed out to 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 Margaret McEntegart†, MD, PhD, Director of the Complex PCI and CTO programs and Cardiac Catheterization Labs at Columbia University Medical Center/NewYork-Presbyterian Hospital, and co-principal investigator of EMPOWER CAD. “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 have traditionally been underrepresented in cardiovascular clinical trials, comprising only around a quarter of enrolled patients in many studies and only a tenth of trial leadership committees. Such underrepresentation for female patients in coronary artery disease studies has led to a lack of actionable gender-specific data to drive improved outcomes, even though women undergoing PCI have a higher risk of procedural complications than men.
“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†, MD, 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.”
The EMPOWER CAD study enrolled 400 participants across 48 sites, spanning five countries, completing enrollment during a live case by Dr. McEntegart at this year’s annual TCT Conference in Washington D.C. Notably, 71% of the enrolling sites were led by female principal investigators, underscoring the study’s commitment to diversity and leadership in clinical research. The study’s European lead is Nieves Gonzalo, MD, PhD, consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain.
“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,” said Nick West, MD, Chief Medical Officer at Shockwave Medical. “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.”
Read also: Johnson & Johnson beat estimates for Q2 profit, revenue
Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751
Dr Kamal Kant Kohli-MBBS, DTCD- a chest specialist with more than 30 years of practice and a flair for writing clinical articles, Dr Kamal Kant Kohli joined Medical Dialogues as a Chief Editor of Medical News. Besides writing articles, as an editor, he proofreads and verifies all the medical content published on Medical Dialogues including those coming from journals, studies,medical conferences,guidelines etc. Email: drkohli@medicaldialogues.in. Contact no. 011-43720751