#United States #New York #Shockwave Medical #IVL #Coronary Disease

New Insights from Shockwave Medical's Latest Study on IVL-First Strategy

A significant breakthrough in cardiovascular care was unveiled at EuroPCR 2025 when Shockwave Medical, Inc., a subsidiary of Johnson & Johnson MedTech, shared encouraging data from its landmark study, EMPOWER CAD. This research is pivotal as it showcases the benefits of an intravascular lithotripsy (IVL)-first strategy specifically for female patients battling complex calcified lesions in their coronary arteries.

Presented as a late-breaking study, the findings suggest that this innovative approach could redefine treatment protocols for women who often face poorer outcomes in coronary interventions compared to their male counterparts. The EMPOWER CAD study, being the first prospective, real-world examination of its kind, has set new standards in promoting inclusion of female participants in cardiovascular clinical trials, as historically they have been underrepresented.

Addressing Gender Disparities in Cardiac Health

Dr. Alexandra Lansky, one of the principal investigators and a leading figure in cardiology at Yale University, highlighted the urgent need for focused research on women, stating, “Women are typically underdiagnosed, underrepresented, and have underwhelming outcomes in coronary artery disease studies.” The EMPOWER CAD study aims to fill this gap, demonstrating how IVL can enhance procedural success rates for women suffering from calcified coronary artery disease.

With 399 participants from 45 locations across five countries—including various sites in the European Union and the United States—this extensive study was overseen by experts including Dr. Margaret McEntegart from Columbia University. The imperative goal was uncomplicated: ascertain if the IVL-first method would deliver sound outcomes comparable to the results seen in male patients.

Key Findings and Results

By the completion of the 30-day mark post-procedure, the study revealed a staggering procedural success rate of 86.9% across all targeted lesions. This was coupled with a primary safety endpoint revealing an overall target lesion failure rate of just 12.1%. Despite the percentage indicating some complications, the majority were asymptomatic, highlighting the procedure's potential safety in real-world applications.

Additionally, only 0.2% of patients experienced severe complications, affirming the method's safety. Significantly, participants reported improvements in their health-related quality of life, underscoring the potential of IVL to enhance patient experience following treatment. “The results confirm that excellent outcomes can be achieved with the use of Shockwave IVL in women with complex, calcified coronary artery disease,” Dr. McEntegart remarked.

Continuing the Journey

As the study continues to follow patients for three years post-treatment, expectations surrounding the long-term efficacy of the IVL-first approach remain hopeful. Dr. Nick West, Chief Medical Officer at Shockwave Medical, pointed out the importance of this research in closing gaps in the understanding of female cardiovascular health. “Today marks a critical milestone in the journey to improve outcomes for female patients with calcified lesions,” he noted, emphasizing the significance of the new data in guiding future treatment protocols.

Overall, the EMPOWER CAD study not only substantiates the benefits of the IVL-first strategy but also heralds a change in how female patients with severe coronary artery calcification are treated in the healthcare landscape. Shockwave Medical is set to remain at the forefront of this evolution in cardiac care, potentially setting a new standard for future interventions and research.