Shockwave EMPOWER CAD Evaluates IVL-First Strategy in Female Patients

May 20, 2025—Shockwave Medical, Inc., part of Johnson & Johnson MedTech, announced the 30-day primary endpoint results of the EMPOWER CAD study.

According to the company, the prospective, real-world study evaluated percutaneous coronary intervention (PCI) using an intravascular lithotripsy (IVL)–first treatment strategy in female patients with severely calcified coronary lesions in complex coronary artery disease. The study was also intended to confirm results from previous studies showing similar safety and effectiveness outcomes across both men and women.

Shockwave stated that the EMPOWER CAD findings confirm the results of earlier retrospective analyses demonstrating the benefits of coronary IVL in female patients.

The 30-day results from EMPOWER CAD were presented in a late-breaking presentation at the EuroPCR 2025 conference held May 20-23 in Paris, France.

As stated by the company in its press release, EMPOWER CAD is Shockwave’s first prospective, postmarket 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 3 years after IVL therapy.

EMPOWER CAD enrolled 399 participants at 45 sites across five countries in the European Union and the United States. The study is led by Coprincipal Investigators Margaret McEntegart, MD, and Alexandra Lansky, MD. The study’s European lead investigator is Nieves Gonzalo, MD.

As summarized in Shockwave’s press release, the primary effectiveness endpoint of procedural success at 30 days was 86.9%, and the primary safety endpoint of target lesion failure (TLF) was 12.1%.

Procedural success was defined as stent delivery with ≤ 30% residual stenosis for all treated target lesions without in-hospital TLF. TLF was defined as a composite of cardiac death, myocardial infarction attributable to the target vessel, or ischemia-driven target lesion revascularization (ID-TLR) within 30 days.

The company further detailed the findings as follows:

• TLF was primarily driven by the rate of periprocedural MI (10.6%). The majority of these MIs were not associated with any clinical signs or symptoms.
• Cardiac death and ID-TLR rates were each 1.3%.
• Procedural complications were rare. One patient (0.2%) had a serious angiographic complication when assessed at the end of the procedure.
• Clinically and statistically significant improvements were shown in health-related quality-of-life scores at 30 days compared to baseline.