Abbott has enrolled the first patient in the world’s first clinical trial designed to study the safety and effectiveness of drug eluting stent treatment in women.
The Xience V Spirit Women trial will study around 2,000 women from 100 sites throughout Europe, Asia-Pacific, Canada and Latin America in order to increase understanding of how heart disease affects women, and to assess the performance of the Xiencev everolimus eluting coronary stent system in women with previously untreated coronary artery lesions.
The trial will evaluate patient and disease characteristics specific to women, such as menopausal status and hormonal profiles, as well as treatment outcomes including death, heart attack, the need for re-treatment (target vessel revascularization, or TVR) and potential risk of stent thrombosis.
“The enrollment of the first patient in this landmark study is important because it has the potential to raise awareness about cardiovascular disease in women and encourage more women with symptoms of the disease to seek treatment,” said Dr John M Capek, President, of Abbott Vascular.
Patients will remain in the trial for 5 years.