Shockwave IVL: Groundbreaking All-Female Clinical Study Fills Critical Evidence Gap and Challenges Historical Perceptions

Johnson & Johnson Announces 30-Day Primary Endpoint Results of EMPOWER CAD Study.EMPOWER CAD Study is the first prospective real-world percutaneous coronary intervention (PCI) study targeting female patients with complex calcified coronary artery disease.EMPOWER CAD Study Results Validate Early Retrospective Analysis Conclusions, Reinforcing Clinical Benefits of Coronary Intravascular Lithotripsy (IVL) for Female Patients.

MPOWER CAD is a pivotal study with several firsts: the first prospective post-market study of Shockwave's IVL, enrolling female patients from a full population with almost no exclusion criteria; the first study to encourage a Shockwave IVL-first PCI strategy for calcified coronary artery lesions; and the first study to conduct a three-year follow-up of patients receiving IVL treatment. This study enrolled 399 patients across 45 centers in Europe and the U.S.

Specific Research Results

• Primary endpoint of effectiveness (Procedural success, defined as successful stent placement in all treated target lesions with residual stenosis ≤30%, and no target lesion failure [TLF] during hospitalization):Reached 86.9% at 30 days。

• The primary safety endpoint (defined as the composite endpoint of TLF within 30 days, including cardiac death, target vessel-related myocardial infarction [TV-MI], or ischemia-driven target lesion revascularization [ID-TLR]):The incidence rate is 12.1%.。

TLF is mainly composed of perioperative myocardial infarction (10.6%), most of which are not accompanied by any clinical signs or symptoms.

The incidence rates of cardiac death and ID-TLR were both 1.3%.

• Surgical complications were rare, with only one patient (0.2%) assessed to have severe angiographic complications at the end of the procedure.

• Compared with the baseline, health-related quality of life scores showed significant improvement both clinically and statistically at 30 days.

PI Evaluation

"In coronary artery disease research, female patients often face issues of underdiagnosis, underrepresentation, and poor clinical outcomes. The purpose of our EMPOWER CAD study is precisely to fill this gap and determine whether Shockwave IVL should be considered a first-line calcium modification approach for women with complex coronary artery disease. The study results confirmed the benefits of IVL in this specific patient population and validated the conclusions of previous studies."

---Alexandra Lansky Yale University School of Medicine

"The 30-day results of the EMPOWER CAD study, which adopted the Shockwave IVL priority strategy, showed that female patients in the real world had a high surgical success rate, low complication rate, and significant improvement in quality of life. We look forward to following up with these patients for the next three years, but the current primary endpoint results have already confirmed that using Shockwave IVL to treat female patients with complex calcified coronary artery disease can achieve excellent outcomes."

---Margaret McEntegart Columbia University Medical Center

Executive Evaluation

"Today marks an important milestone in the journey to improve clinical outcomes for women with calcified lesions. Thanks to the efforts of the study leaders and researchers at various centers, an idea conceived several years ago has now become a commendable reality. We look forward to further understanding the short-term and long-term follow-up benefits of IVL treatment in this underrepresented patient population."

---Nick West  Chief Medical Officer of Shockwave Medical

Traditionally, women with coronary artery calcification (CAC) undergoing PCI treatment have often been underrepresented in clinical trials and historically have had worse clinical outcomes than men, including an increased risk of adverse clinical outcomes, as well as the use of rotational atherectomy orOrbital RotablationThe incidence of surgical complications is relatively high in other calcification modification treatments.

Johnson & Johnson through all-femaleReal-world studies break traditional misconceptions, usingAcceptance after Shockwave IVL treatmentPCISurgical Treatment for Female PatientsHigh success rate, low complication rate, and significant improvement in quality of life.