Johnson & Johnson has put forward a clinical study exploring the use of its Shockwave Medical division’s vessel-clearing approach as the primary procedure for women with hardened, calcified blockages within the heart’s coronary arteries.
These women have historically seen poorer outcomes than men when it comes to the minimally invasive procedures to clear paths through those blood vessels, known as percutaneous coronary interventions, or PCI.
When it comes to other methods of breaking through calcium deposits—such as rotational or orbital atherectomy, to prepare for the use of a stent or an artery-widening balloon—women have also seen an increased risk of complications, according to J&J. Female patients have also largely been excluded from many clinical trials, across different medical specialties.
Shockwave’s intravascular lithotripsy procedure, or IVL, employs sonic pressure waves to crack calcium deposits from within the vessel. The company said its postmarket study is its first to test an IVL-first PCI strategy, and its first to enroll an all-comer female population with minimal exclusion criteria.
The international, real-world trial of nearly 400 people, dubbed EMPOWER CAD, met its endpoints—with about 87% of those being treated successfully receiving a stent and maintaining a more-open artery after 30 days.
In that time, about 12% of participants suffered either a myocardial infarction linked to the targeted vessel, a vascular blockage requiring reintervention, and/or cardiac death, together offering a composite measurement of lesion failure.
The company said the majority of myocardial infarctions that occurred during or immediately after the procedure were not associated with any clinical signs or symptoms while the rates of cardiac death and revascularization taken separately were both 1.3%.
“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,” said the study’s co-principal investigator, Margaret McEntegart, director of the cardiac catheterization labs at Columbia University Medical Center and NewYork-Presbyterian Hospital.
“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,” McEntegart said in a statement.
The study’s results were presented as a late-breaking trial at the annual EuroPCR meeting, being held this week in Paris.
“Women are typically underdiagnosed, underrepresented and have underwhelming outcomes in coronary artery disease studies,” said co-principal investigator Alexandra Lansky, director of the heart and vascular clinical research program at the Yale University School of Medicine.
“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.”