Abbott announced that the first patient was enrolled in its XIENCE V SPIRIT WOMEN clinical trial, the world's first clinical trial designed to study the safety and effectiveness of drug eluting stent treatment in women. Liliana Grinfeld, M.D., of the Hospital Italiano in Buenos Aires, Argentina, performed the first procedure.
The goal of the XIENCE V SPIRIT WOMEN trial is to increase understanding of how heart disease affects women and to assess the performance of the XIENCE V Everolimus Eluting Coronary Stent System in women with previously untreated coronary artery lesions from Europe, Asia-Pacific, Canada and Latin America. The trial will focus on specific aspects of women's health in relation to coronary artery disease such as general awareness about the disease, symptoms at time of presentation, referral patterns, and hormonal menopausal status.
"We are honoured to have enrolled the first patient in the important XIENCE V SPIRIT WOMEN trial, because it is designed to address issues associated with the under-treatment of women with cardiovascular disease," said Dr. Grinfeld. "The XIENCE V Everolimus Eluting Coronary Stent System performed well, and as with all patients enrolled in the XIENCE V SPIRIT WOMEN trial, the patient will be followed out to 5 years."
Each year, more women than men die of cardiovascular disease (CVD), and yet women receive only 33 per cent of angioplasties, stents and bypass surgeries; 28 per cent of implantable defibrillators; and 36 per cent of open-heart surgeries.
"With more women dying of cardiovascular disease than men, it is tragic that women comprise only 25 per cent of participants in all heart-related research studies," said Marie-Claude Morice, M.D., Institute Jacques Cartier, Massy, France, and principal investigator for XIENCE V SPIRIT WOMEN. "As the first trial designed to investigate drug-eluting stent treatment in women, XIENCE V SPIRIT WOMEN has the potential to enhance access to therapy for women by increasing physicians' and women's awareness about cardiovascular disease."
Women with CVD may be under-treated because disease diagnosis is more challenging in women than in men. Women typically exhibit different symptoms than men, and their symptoms often are more gradual and subtle. For example, rather than the more commonly recognized symptoms such as the sudden violent chest pain, or uncomfortable pressure or fullness that are predominant in men, women may experience other warning signs such as shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue, and back, shoulder blade or jaw pain. XIENCE V SPIRIT WOMEN will yield specific data on how the disease presents in women.
XIENCE V SPIRIT WOMEN clinical trial is the first large interventional study to study how cardiovascular disease differs in women from men. XIENCE V SPIRIT WOMEN will include approximately 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. 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 enrolment 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 John M. Capek, Ph.D., president, Abbott Vascular. "XIENCE V SPIRIT WOMEN, and the entire SPIRIT family of clinical trials, demonstrates Abbott's commitment to providing the best technologies for the treatment of cardiovascular disease, and ensuring that these technologies are used safely and effectively in both women and men."
XIENCE V was launched in Europe and Asia Pacific in 2006. XIENCE V is currently an investigational device in the United States and Japan. Abbott completed its Premarket Approval (PMA) submission of the XIENCE V system to the United States Food and Drug Administration (FDA) in June 2007.
The XIENCE V system utilizes everolimus, which has been shown to reduce tissue proliferation in coronary vessels following stent implantation, and one of the world's most popular metallic platforms - the MULTI-LINK VISION Coronary Stent System.
XIENCE V is designed, studied and manufactured by Abbott Vascular. Abbott supplies a private-labelled version of XIENCE V to Boston Scientific, called the PROMUS Everolimus Eluting Coronary Stent System, as part of a distribution agreement established between the two companies last year.