Shockwave Medical, part of Johnson & Johnson MedTech, has announced promising results from the EMPOWER CAD study, confirming the benefits of an intravascular lithotripsy (IVL)-first strategy in female patients with complex calcified coronary lesions. The 30-day primary endpoint results were presented as a late-breaking presentation at the annual EuroPCR meeting in Paris on May 20, 2025.
The EMPOWER CAD study represents a significant milestone as the first prospective, real-world percutaneous coronary intervention (PCI) study focused exclusively on female patients with complex, calcified coronary artery disease. The study enrolled 399 women across 45 sites in five countries throughout the European Union and United States.
Addressing a Critical Gender Gap in Cardiovascular Care
Women with coronary artery calcification (CAC) undergoing PCI have historically experienced poorer outcomes compared to men, including increased risk of adverse clinical events and higher rates of procedural complications with traditional calcium modification treatments such as rotational or orbital atherectomy.
"Women are typically underdiagnosed, underrepresented and have underwhelming outcomes in coronary artery disease studies," said Dr. Alexandra Lansky, Professor of Medicine at Yale University School of Medicine and co-principal investigator of the study. "Our goal with the EMPOWER CAD study was to address this gap and determine whether Shockwave IVL should be considered as the front-line calcium modification approach in female patients with complex coronary artery disease."
The study was designed to evaluate real-world outcomes in female patients with severely calcified coronary lesions treated with an IVL-first treatment strategy and validate positive results from previous retrospective analyses showing similar safety and effectiveness outcomes across both genders.
Impressive 30-Day Results
The primary effectiveness endpoint of procedural success, defined as stent delivery with ≤30% residual stenosis for all treated target lesions without in-hospital target lesion failure (TLF), was achieved in 86.9% of patients at 30 days.
The primary safety endpoint, defined as TLF (a composite of cardiac death, myocardial infarction attributable to target vessel, or ischemia-driven target lesion revascularization) within 30 days, was 12.1%. This was primarily driven by periprocedural myocardial infarction rates of 10.6%, with most of these events not associated with clinical signs or symptoms. Cardiac death and ischemia-driven target lesion revascularization rates were each 1.3%.
Notably, procedural complications were rare, with only one patient (0.2%) experiencing a serious angiographic complication when assessed at the end of the procedure. Patients also reported clinically and statistically significant improvements in health-related quality of life scores at 30 days compared to baseline.
Expert Perspectives on Study Impact
Dr. Margaret McEntegart, Director of the Complex PCI and CTO programs at Columbia University Medical Center/NewYork-Presbyterian Hospital and co-principal investigator, emphasized the significance of these findings: "By leveraging a Shockwave IVL-first approach, the EMPOWER CAD 30-day results demonstrated high procedural success, low complication rates and significant improvements in quality of life among real-world female patients. While we look forward to following these patients for the next three years, these primary endpoint results confirm that excellent outcomes can be achieved with the use of Shockwave IVL in women with complex, calcified coronary artery disease."
The study is particularly noteworthy for being Shockwave's first prospective, post-market study examining an all-comers female population with minimal exclusion criteria, the first to encourage an IVL-first PCI strategy for calcified coronary lesions, and the first to follow enrolled patients for three years following IVL therapy.
Dr. Nick West, Chief Medical Officer at Shockwave Medical, highlighted the importance of the study: "Today marks a critical milestone in the journey to improve outcomes for female patients with calcified lesions. What began as an idea a few years ago is now a commendable reality today, thanks to study leadership and site investigators accelerating completion and reporting these important results."
Innovative Technology for Challenging Lesions
Shockwave's Intravascular Lithotripsy technology represents a novel approach to treating calcified coronary lesions. The system uses sonic pressure waves to disrupt challenging calcified plaque, similar to how lithotripsy has been used for decades to treat kidney stones. This approach allows for safer modification of calcified lesions compared to traditional methods.
The EMPOWER CAD study was led by co-principal investigators Dr. McEntegart and Dr. Lansky, with Dr. Nieves Gonzalo from Hospital Clinico San Carlos in Madrid, Spain, serving as the European lead.
The study will continue to follow patients for three years, providing valuable long-term data on the effectiveness and safety of the IVL-first approach in this historically underrepresented patient population. These initial results suggest that Shockwave IVL may offer a promising alternative for female patients with complex, calcified coronary artery disease who have traditionally faced poorer outcomes with conventional treatment approaches.
