Johnson & Johnson Study Reveals Promise of Shockwave-First Approach for Women with Calcified Coronary Arteries

Johnson & Johnson has unveiled groundbreaking results from a clinical study that explores a novel approach to treating women with calcified coronary artery disease. The EMPOWER CAD trial, which focused exclusively on female patients, demonstrates the potential of using Shockwave Medical's intravascular lithotripsy (IVL) as a primary intervention strategy.

Addressing Gender Disparities in Cardiovascular Care

Historically, women have experienced poorer outcomes than men in percutaneous coronary interventions (PCI) for clearing blocked arteries. They have also faced increased risks of complications with traditional calcium-breaking methods such as rotational or orbital atherectomy. Moreover, female patients have been largely underrepresented in clinical trials across various medical specialties.

The EMPOWER CAD study aims to address these gender disparities by examining the efficacy of Shockwave's IVL technology as a first-line treatment for women with complex, calcified coronary artery disease. This marks a significant step towards improving cardiovascular care for female patients.

Promising Results from the EMPOWER CAD Trial

The international, real-world study enrolled nearly 400 women and yielded encouraging results:

• Approximately 87% of patients were successfully treated, receiving a stent and maintaining a more open artery after 30 days.
• The composite endpoint of lesion failure, which included myocardial infarction linked to the targeted vessel, vascular blockage requiring reintervention, and cardiac death, occurred in about 12% of participants within 30 days.
• Rates of cardiac death and revascularization were both 1.3% when considered separately.

Dr. Margaret McEntegart, co-principal investigator and director of the cardiac catheterization labs at Columbia University Medical Center and NewYork-Presbyterian Hospital, noted, "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."

Implications for Future Cardiovascular Treatment

The EMPOWER CAD study represents a significant advancement in the treatment of coronary artery disease in women. Dr. Alexandra Lansky, co-principal investigator and director of the heart and vascular clinical research program at the Yale University School of Medicine, emphasized the importance of this research: "Women are typically underdiagnosed, underrepresented and have underwhelming outcomes in coronary artery disease studies. 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 positive results from this trial suggest that Shockwave's IVL technology could become a preferred treatment option for women with calcified coronary arteries. As researchers continue to follow these patients for the next three years, the long-term efficacy and safety of this approach will be further evaluated, potentially reshaping treatment protocols for female cardiovascular patients.