All-Female Coronary IVL Study Enrollment Complete

Shockwave Medical Inc., part of Johnson & Johnson MedTech, has finished enrolling patients in EMPOWER CAD, the first prospective all-female study of percutaneous coronary intervention (PCI) in complex calcific disease.

The study seeks 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 next year, 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,* M.D., Ph.D., 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 about a quarter of enrolled patients in many studies¹ and only a tenth of trial leadership committees.² 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.³ 

“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,” stated Alexandra Lansky,* M.D., 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, M.D., Ph.D., 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,” Shockwave Medical Chief Medical Officer Nick West, M.D., remarked. “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.”  

Shockwave Medical, part of Johnson & Johnson MedTech, develops and commercializes cardiovascular disease treatment solutions. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed the treatment of atherosclerotic cardiovascular disease by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, is designed to provide relief to patients suffering from refractory angina by redistributing blood flow within the heart.

Johnson & Johnson MedTech’s cardiovascular portfolio provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation technologies that address conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. Johnson & Johnson MedTech considers itself a global leader in heart recovery, circulatory restoration and heart rhythm disorder treatment, as well as an emerging leader in neurovascular care.  

Johnson & Johnson’s expertise in Innovative Medicine and MedTech positions the company to innovate across the full spectrum of healthcare solutions to deliver breakthroughs that profoundly impact human health.

*Drs. McEntegart and Lansky are paid consultants of Shockwave Medical.

References
¹ X. Jin, et al. Women’s participation in cardiovascular clinical trials from 2010 to 2017. Circulation, 141 (7) (2020), pp. 540-548 
² K. Denby, et al. Representation of women in cardiovascular clinical trial leadership. JAMA Intern Med, 180 (2020), pp. 1382-1383
³ M. McEntegart, et al. Sex differences in procedural and clinical outcomes following rotational atherectomy. Catheter Cardiovasc Interv. 2020 Feb;95(2):232-241