Treating Women With Calcified Coronary Arteries Using Intravascular Lithotripsy: Primary Results of the EMPOWER CAD...

Percutaneous coronary intervention of severely calcified coronary lesions is associated with a higher risk of adverse events in women compared with men.

EMPOWER CAD (NCT05755711) is a prospective, multicenter, single-arm "real-world" study of women receiving intravascular lithotripsy (IVL) to treat calcific coronary artery lesions. The 30-day primary safety end point was target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI), or ischemia-driven target lesion revascularization. Procedural success was defined as successful stent delivery with residual stenosis ≤30% without in-hospital TLF.

A total of 399 women were enrolled at 45 centers in Europe and the United States. Mean age was 73 ± 10 years; diabetes (46.1%), prior MI (32.3%), chronic kidney disease (27.8%), and prior percutaneous coronary intervention (38.8%) were prevalent. Of the patients, 23.3% presented with NSTE-ACS, 16.0% with LVEF ≤40%, 7.3% of target lesions were in the left main artery, and severe calcification was present in 99.3%. IVL was the first calcium-modifying treatment for 90.6% of lesions. Procedural success (87.4%) and TLF at 30 days (11.6%) were both driven by the 9.6% periprocedural MI rate per the Society for Cardiovascular Angiography & Interventions (SCAI) definition. Diameter stenosis was reduced from 78% ± 12% at baseline to 46% ± 12% after IVL, and to 12% ± 7% in-stent at final angiography. Seattle Angina Questionnaire (SAQ)-7, European Quality of Life 5 Dimension 5 Level (EQ-5D-5L), and GAD-7 quality-of-life measures all showed significant improvements at 30 days (P < .0001).

In the real-world EMPOWER CAD study, an IVL-first strategy demonstrated a favorable safety profile, high procedural success, and significant stenosis reduction and quality of life improvement at 30 days, consistent with or better than prior IVL studies performed in predominantly male populations.