IVL delivers significant value for women, real-world data confirm
Shockwave Medical, now a part of Johnson & Johnson MedTech, has shared new data highlighting the safety and effectiveness of its intravascular lithotripsy (IVL) technology in female patients at the annual EuroPCR meeting in Paris.
Shockwave Medical a known pioneer of the rapidly expanding IVL space, first announced the EMPOWER CAD clinical trial back in 2022. The study enrolled 399 real-world patients from 45 different treatment sites. All patients were women who presented with severely calcified coronary lesions; they were all treated with IVL using the Shockwave C2 Coronary IVL catheter prior to percutaneous coronary intervention (PCI). Each patient will be followed for three years; the data presented at EuroPCR represented initial 30-day outcomes.
“Women are typically underdiagnosed, underrepresented and have underwhelming outcomes in coronary artery disease studies,” co-principal investigator Alexandra Lansky, MD, professor of medicine in the section of cardiovascular medicine and director of the Heart and Vascular Clinical Research Program at Yale University School of Medicine, said in a statement. “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 results demonstrate the benefits of IVL use in this specific patient population and validate findings from previous studies.”
Overall, procedural success—defined as stent delivery with ≤30% residual stenosis for all treated target lesions and without in-hospital target lesion failure (TLF)—was seen in 86.9% of patients after 30 days. The study’s primary safety endpoint, a composite of cardiac death, target vessel-related myocardial infarction or ischemia-driven target lesion revascularization (ID-TLR), was seen in 12.1% of patients after 30 days. The cardiac death and ID-TLR rates were each 1.3%, meanwhile, and only a single serious angiographic complication was reported.
Quality of life scores, researchers added, were significantly higher 30 days after treatment.
“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,” co-principal investigator Margaret McEntegart, MD, PhD, director of the complex PCI and CTO programs and cardiac cath labs at Columbia University Medical Center/NewYork-Presbyterian Hospital, said in the same statement.
“Today marks a critical milestone in the journey to improve outcomes for female patients with calcified lesions,” added Nick West, MD, Shockwave Medical’s chief medical officer. “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. We’re looking forward to learning more about the benefits of IVL therapy in this underrepresented patient population, both acutely and at extended follow-up.”
EuroPCR runs May 20-23 in Paris. Click here for additional details.
Michael has more than 18 years of experience as a professional writer and editor. He has written at length about cardiology, radiology, artificial intelligence and other key healthcare topics.