Shockwave Medical Study Reaffirms Positive Outcomes for Coronary IVL

Shockwave Medical Inc., part of Johnson & Johnson MedTech, is sharing favorable 30-day primary endpoint results from EMPOWER CAD, the first prospective, real-world percutaneous coronary intervention (PCI) study in female patients with complex, calcified coronary artery disease. The data confirm the results of earlier retrospective analyses demonstrating the benefits of coronary intravascular lithotripsy (IVL) in female patients.

“This marks a critical milestone in the journey to improve outcomes for female patients with calcified lesions,” Shockwave Medical Chief Medical Officer Nick West., M.D., commented. “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.” 

Investigators designed the EMPOWER CAD study to evaluate real-world outcomes in female patients with severely calcified coronary lesions treated with an IVL-first treatment strategy and confirm positive results from previous studies showing similar safety and effectiveness outcomes across both men and women. EMPOWER CAD is a pivotal study comprised of a series of firsts: Shockwave’s first prospective, post-market study of IVL examining an all-comers female population with minimal exclusion criteria, the first study to encourage a Shockwave IVL-first PCI strategy for calcified coronary lesions, and the first study to follow-up with enrolled patients for three years following IVL therapy. 

The study enrolled 399 participants across 45 sites in five countries (European Union and the United States). The study is led by co-principal investigators Margaret McEntegart, M.D., Ph.D., director of the Complex PCI and CTO programs and Cardiac Catheterization Labs at Columbia University Medical Center/NewYork-Presbyterian Hospital; and Alexandra Lansky, M.D., professor of Medicine in the section of Cardiovascular Medicine and director, Heart and Vascular Clinical Research Program, Yale University School of Medicine. The study’s European lead is Nieves Gonzalo, M.D., Ph.D., consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, Spain.† 

“Women are typically underdiagnosed, underrepresented, and have underwhelming outcomes in coronary artery disease studies,” Dr. Lansky said. “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.” 

Women with coronary artery calcification (CAC) undergoing PCI are often underrepresented in clinical trials and have historically worse outcomes than men, including increased risk of adverse clinical outcomes and high rates of procedural complications with other calcium modification treatments, such as rotational or orbital atherectomy.^1,2 

The primary effectiveness endpoint of procedural success, defined as stent delivery with ≤30% residual stenosis for all treated target lesions without in-hospital target lesion failure (TLF), was 86.9% at 30 days. The primary safety endpoint, defined as 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, was 12.1%. TLF was primary driven by the rate of periprocedural MI³ (10.6%); the majority of these periprocedural MIs were not associated with any clinical signs or symptoms. Cardiac death and ID-TLR rates were each 1.3%. Procedural complications were rare with only one patient (0.2%) having a serious angiographic complication when assessed at the end of the procedure. There were also clinically and statistically significant improvements in health-related quality of life scores at 30 days compared to baselines. 

“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,” Dr. McEntegart stated. “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 Medical Inc. develops and commercializes cardiovascular disease treatment products. Its first-of-its-kind Intravascular Lithotripsy (IVL) technology has transformed atherosclerotic cardiovascular disease treatment by safely using sonic pressure waves to disrupt challenging calcified plaque, resulting in significantly improved patient outcomes. Its Reducer technology, which is under clinical investigation in the United States and is CE Marked in the European Union and the United Kingdom, provides relief to patients suffering from refractory angina by redistributing blood flow within the heart.

Johnson & Johnson tackles the world’s most complex and pervasive health challenges. Through a cardiovascular portfolio that provides healthcare professionals with advanced mapping and navigation, miniaturized tech, and precise ablation, the company addresses conditions with significant unmet needs such as heart failure, coronary artery disease, stroke, and atrial fibrillation. The firm considers itself a leader in heart recovery, circulatory restoration, and heart rhythm disorder treatments, as well as an emerging leader in neurovascular care, committed to taking on two of the leading causes of death worldwide in heart failure and stroke. 

† Drs. McEntegart, Lansky and Gonzalo are paid consultants of Shockwave Medical.

References
¹ Giustino et al., JACC Cardiovasc Int 2016; Ford et al., Catheter Cardiovasc Interv 2020; Hussain et al., JSCAI 2022.
² Kim et al. Catheter Cardiovasc Interv. 2016
³ As defined by SCAI for periprocedural MI and Fourth Universal (Type 4a) for spontaneous MI beyond discharge