Equity in Modifying Plaque of Women With Undertreated Calcified Coronary Artery Disease: Design and Rationale of EMPOWER CAD study

Abstract

Background: Coronary artery disease (CAD) is the leading cause of death for women, yet they remain underrepresented in interventional CAD studies. Women have been shown to be at increased risk of mortality and major adverse events after percutaneous coronary intervention (PCI). The poorer outcomes are likely because women are typically diagnosed with CAD late, at an older age, with more comorbidities, and with more challenging anatomy including smaller vessels and higher prevalence of coronary artery calcification. Methods: The EMPOWER CAD study (NCT05755711) is a postmarket, prospective, multicenter, single-arm observational study of the Shockwave Coronary intravascular lithotripsy (IVL) system for the treatment of women with calcified coronary artery disease. The study will enroll 400 female patients referred for PCI with coronary IVL and stenting. The primary safety end point is target lesion failure (TLF) at 30 days, defined as a composite of cardiac death, target vessel myocardial infarction, or ischemia-driven target lesion revascularization. The primary effectiveness end point is procedural success, defined as stent delivery with a residual in-stent stenosis ≤30% in all target lesions and without in-hospital TLF as assessed by an independent core laboratory and clinical events committee. Patients will be followed up for 3 years. Conclusions: The EMPOWER CAD study will enroll real-world female patients. Adjunctive use of IVL with other calcium modification technologies will be assessed, as well as a subcohort analysis of patients with optical coherence tomography imaging. The EMPOWER CAD study therefore directly addresses the underrepresentation of women in interventional cardiology clinical trials.

Keywords

• arteriosclerosis
• cardiovascular disease
• coronary artery disease
• intravascular lithotripsy
• percutaneous coronary intervention