Abbott announced plans to initiate the world's first drug-eluting stent clinical trial solely in women. The Spirit Women trial will aim to increase understanding of how heart disease affects women, and will assess the performance of the Xience V Everolimus Eluting Coronary Stent System in women with previously untreated coronary artery lesions.

Each year, more women than men die of cardiovascular disease (CVD), 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. This may be attributed to the fact that diagnosis of CVD in women is more challenging than in men, as women typically exhibit different symptoms than men because their symptoms are more gradual and subtle. Rather than the more commonly-recognized symptoms, such as sudden violent chest pain, or uncomfortable pressure, or fullness, that are predominate in men, women may experience other warning signs, particularly shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue and back, shoulder blade or jaw pain.
"Even though more women than men die from cardiovascular disease each year, women today comprise only 25 per cent of participants in all heart-related research studies," said Marie-Claude Morice, M.D., Institute Jacques Cartier, Massy, France, principal investigator for Spirit Women. "Cardiovascular disease in women is under diagnosed and under treated because the differences between men and women are not well understood. The Spirit Women trial is meant to help improve our understanding of cardiovascular disease in women, and the best ways to care for women with CVD."

The Spirit Women clinical trial is the first large interventional study to solely study CVD in women and how it differs from men. The Spirit Women trial will include approximately 2,000 women from 100 sites throughout Europe, Asia-Pacific, Canada and Latin America. The study will evaluate patient and disease characteristics specific to women as well as treatment outcomes such as rate of death, heart attack and target vessel revascularization (TVR) and potential risk of stent thrombosis. The trial will yield specific data on CVD and how it is diagnosed in women.

"The Spirit women trial will contribute to therapy access by increasing awareness and understanding of CVD in women while further evaluating the performance of our Xience V drug-eluting stent in this patient population," said John M. Capek, Ph.D., president, Abbott Vascular. "As a leader in vascular care, Abbott believes that it is our role not only to provide the best technologies, but also to ensure that they are being used effectively in as broad a patient population as possible."

Pending requisite approvals from regulatory bodies and clinical trial sites, patients are expected to begin enrolling in Spirit Women by mid-2007, an Abbott press release stated.

Spirit Women represents the sixth study in the Spirit Clinical Trial Program and will increase the number of patients being studied in the Spirit family of trials to approximately 8,000. The six studies evaluating the Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease are:

Spirit First - First-in-man study showed positive results through two years with no major adverse cardiac events between one and two years for patients with de novo (previously untreated) native coronary artery lesions.

Spirit II - Six-month results of the trial conducted in Europe and Asia-Pacific demonstrated superiority of the Xience V stent system to the Taxus paclitaxel-eluting coronary stent system with respect to the study's primary endpoint, which was angiographic in-stent late loss at six months.

Spirit III - This large-scale pivotal clinical trial compares the Xience V system to the Taxus stent system in the United States and Japan. The randomized arm of this trial completed patient enrollment in March 2006.

Spirit IV - This trial, which is currently enrolling patients, will evaluate the safety and efficacy of the Xience V system for the treatment of coronary artery disease in a more complex patient population in the United States.

Spirit V - This study will provide additional clinical experience with the Xience V system throughout Europe, Asia-Pacific and Canada in real-world patients. One subset of the study is dedicated to diabetic patients.

Spirit Women - The world's first drug-eluting stent trial to study only women will evaluate the characteristics of women undergoing stent implantation and performance of XIENCE V in those patients in Europe, Asia-Pacific, Canada and Latin America.

The Xience V system, which was launched recently in Europe and has received CE Mark approval, utilizes the drug everolimus and the highly deliverable and proven Multi-Link Vision coronary stent platform. Everolimus has been shown to reduce tissue proliferation in coronary vessels following stent implantation. The Xience V system is currently an investigational device in the United States and Japan. Pending requisite regulatory approvals, Abbott expects to launch Xience V in the United States in the first half of 2008 and in Japan the following year.