Feb. 7, 2007 — Abbott has announced its plan to launch the world's first drug-eluting stent clinical trial solely in women. Performance of the Xience V Everolimus Eluting Coronary Stent System will be the focus of the SPIRIT WOMEN trial, designed specifically to study CVD in women and how it differs from men. Xience V is not FDA cleared for commercial sale in the U.S.
Approximately 2,000 women from 100 sites throughout Europe, Asia-Pacific, Canada and Latin America will be included in the trial, which 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.
According to the National Center on Health Statistics, more women than men die of cardiovascular disease every year, yet women receive only 33 percent of angioplasties, stents and bypass surgeries; 28 percent of implantable defibrillators; and 36 percent of open-heart surgeries. This may be partially explained by the greater diagnosis challenges in women, who exhibit different, and often more gradual and subtle symptoms such as shortness of breath, dizziness, nausea, indigestion, vomiting, unexplained fatigue and back, shoulder blade or jaw pain.
"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, patient enrollment may begin by mid-2007.
For more details visit www.abbott.com .