Shockwave announced 30-day primary endpoint results from the EMPOWER CAD study of its intravascular lithotripsy (IVL) therapy. It marks the first prospective, real-world percutaneous coronary intervention (PCI) study in female patients with complex, calcified coronary artery disease. Shockwave completed enrollment in the study last fall.
[See Dr. Nick West, chief medical officer of Shockwave Medical, discuss the company’s IVL technology at DeviceTalks Minnesota, June 11, 2025, at the University of Minnesota’s McNamara Alumni Center.]
Favorable results confirm the results of an early retrospective analysis demonstrating the benefits of coronary IVL in female patients. Investigators presented findings at the annual EuroPCR meeting in Paris.
The investigators designed EMPOWER CAD to evaluate real-world outcomes in female patients with severely calcified coronary lesions. Subjects underwent an IVL-first treatment strategy, with findings confirming positive results from previous studies, the company said. The study showed similar safety and effectiveness outcomes across both men and women.
Shockwave said the study enrolled 399 participants across 45 sites in five countries in Europe as well as in the U.S. Co-principal investigators Dr. Margaret McEntegart and Dr. Alexandra Lansky led the study. Dr. Nieves Gonzalo out of Madrid served as European lead.
“Women are typically underdiagnosed, underrepresented and have underwhelming outcomes in coronary artery disease studies,” said Lansky. “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.”
More about the Shockwave IVL study
The study had a primary effectiveness endpoint of procedural success. Investigators defined this as stent delivery with ≤30% residual stenosis for all treated target lesions without in-hospital target lesion failure (TLF). That came in at 86.9% at 30 days.
Investigators had a primary safety endpoint of TLF as a composite of cardiac death, myocardial infarction attributable to target vessel (TV-MI) or ischemia-driven target lesion revascularization (ID-TLR) within 30 days. That came in at 12.1%.
The study also saw clinically and statistically significant improvements in health-related quality of life scores compared to baseline.
“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,” said Dr. McEntegart. “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.”
Shockwave said the rate of periprocedural MI (10.6%) primarily drove TLF. The majority of those periprocedural MIs were not associated with any clinical signs or symptoms. Cardiac death and ID-TLR rates each came in at 1.3%.
Investigators reported rare procedural complications. They reported just one patient (0.2%) having a serious angiographic complication when assessed at the end of the procedure.
“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,” said Dr. Nick West., chief medical officer, Shockwave Medical. “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.”
