PARIS – A 30-day analysis of the EMPOWER CAD trial demonstrates that the Shockwave coronary intravascular lithotripsy (IVL) device is effective in the treatment of women with coronary artery disease (CAD) and calcified lesions. Additionally, this procedure leads to significant increases in quality of life (QoL), anxiety and angina in this patient population. Margaret B. McEntegart, MD, PhD, of the Columbia University Irving Medical Center, New York, presented these results during the New Evidence for Treatment of Calcified CAD session on Tuesday at the EuroPCR Congress 2025. Women are often under-represented in trials exploring percutaneous coronary intervention (PCI) and associated devices. Studies show higher mortality rates. “Studies also show higher complication rates, especially during atherectomy,” Dr. McEntegart said during her presentation. EMPOWER CAD (Equity in Modifying Plaque Of WomEn With UndeRtreated Calcified Coronary Artery Disease) is a prospective, multicenter, observational study investigating the use of the Shockwave IVL (Shockwave Medical) for treatment of calcified CAD in women. A total of 399 patients are currently enrolled in the study (mean age=73 years). The patients were considered high-risk because of their age and several reported comorbidities, including female-specific risk factors such as gestational diabetes (10%). The primary safety endpoint is target lesion failure (TLF), a composite of cardiac death, myocardial infarction (MI) attributable to target vessel (TV)-MI or ischemia-driven target lesion revascularization (ID-TLR). The primary effectiveness endpoint is stent delivery with residual in-stent restenosis rates ≥30% in all target lesions with no TLF. At 30-days, 12% experienced TLF (1.3% of patients died due to cardiac causes, 1.5% of patients had spontaneous MI, ID-TLR included 1.3%, procedural MI varied by definitions). A total of 449 lesions were treated. Procedural success occurred in 90.6% of patients. QoL, anxiety and angina were all measured and showed significant improvement at 30-days. Overall, the use of the Shockwave coronary IVL system was both safe and efficient at 30-days in women with calcified CAD, and QoL measures improved over this time. Image Credit: HBS – stock.adobe.com