Research: Putting Women’s CVD on Trial

One of the obstacles in improving the standard of care for women with cardiovascular disease has been the lack of pre-specified gender-based clinical research. Women are under-represented in clinical trials and there is an unmet clinical need due to a basic lack of knowledge and study of the disparity in treatment and related outcomes between men and women. Sample sizes in clinical trials are skewed toward males and not oriented toward focused data analysis for women. Fewer women are enrolled in cardiovascular clinical trials (15-30%), among other challenges.¹

The SPIRIT Family of Trials: Abbott Vascular is the only cardiovascular device company sponsoring a clinical trial solely dedicated to the study of women, and thus helping meet the vital need for clinical research specific to women’s heart health. The decision to invest in trials to study women was made from a formidable and building body of data emerging from the SPIRIT family of trials, sponsored by Abbott Vascular, which shows promising trends in the treatment and care of women with coronary artery disease. Based on these trends, Abbott Vascular identified the need to develop gender specific data as critical for contributing to evidence based medicine for women.

1. Status of Women in Clinical Trials. Kim, Menon Arteriosclerosis, Thrombosis, Vascular Biology 2009;29;279-283

SPIRIT WOMEN

• A post-market study targeting only female population
• Primary endpoint of All Death, All Myocardial Infarction and Target Vessel Revascularization at one year
• Characterize the female population implanted with XIENCE V stents, examining baseline demographics and differences in outcomes due to variations in treatment
• Continued assessment of XIENCE V with the primary focus on clinical outcomes in the treatment of female patients. For Indications and Important Safety Information, click here.

AP2930798 Rev. A