Two SCAI Women in Innovations (WIN) initiatives and SCAI’s newest health disparities program were featured at this summer’s Food and Drug Administration (FDA) Health of Women (HoW) workshop, where more than 100 stakeholders from academia, government, and industry discussed strategies for promoting women’s health and understanding sex-specific differences in medical research. During a session on how to influence device research to address the unique issues related to women’s health, Roxana Mehran, M.D., FSCAI, presented on SCAI WIN’s all-female transcatheter aortic valve implantation (TAVI) registry and drug-eluting stent data pooling project as well as the Health Disparities Research Consortium (HDRC).
Throughout the two-day workshop, participants discussed strategies for improving recruitment and retention of women in device trials and approaches to enhancing communication of sex-specific findings to healthcare providers and their patients.
“Coronary artery disease is still considered to be a disease that affects males more than females. This bias is reflected in findings that women consistently receive lower rates of catheterization, lower rates of percutaneous coronary intervention (PCI), and lower rates of cardiac surgery, despite having the same disease rates,” said Suzanne Baron, M.D., an interventional cardiology fellow-in-training at Massachusetts General Hospital who recently completed a fellowship at the FDA’s Center for Devices and Radiological Health. “This fact highlights the importance of acknowledging the sex-based disparities that exist in clinical trial development and improving the research ecosystem of device development for women. “
Dr. Baron moderated the FDA workshop’s cardiovascular research session, where Dr. Mehran presented the SCAI WIN initiatives and HDRC. Dr. Mehran shared progress on the WIN TAVI female registry, a multi-center prospective study launched in Europe that has already enrolled more than 140 patients and is on track to reach its goal of 1,000 patients. In addition to collecting standard information on cardiac risk factors and outcomes data, the registry is also capturing data on female-specific health concerns, such as menopause status and osteoporosis.
“The WIN TAVI Registry is the first all-female registry of patients receiving transcatheter valve replacement,” explained Dr. Mehran. “It is part of an important effort to understand how female-specific health variables may affect outcomes for women after TAVI.”
Workshop participants also heard from Dr. Mehran on ongoing efforts to facilitate collaboration among device companies and researchers in order to pool and analyze randomized clinical trial data on women who have received drug-eluting stents. “Data on more than 11,000 women from over 20 studies have been collected through this effort,” she said. “And we are looking forward to presenting the results as a Hotline session at the 2013 European Society of Cardiology Congress in Amsterdam in September.”
Finally, Dr. Mehran introduced the HDRC, a SCAI-sponsored research initiative that is serving as a platform for innovative clinical research activities with significant potential to bridge health disparity gaps.
“HDRC projects are currently focused on cardiovascular care,” said Dr. Mehran, “but our intent is to expand into other medical fields.”
“We must continue working to raise awareness of the need to focus on population-specific issues in cardiovascular research,” said Dr. Baron. “Government-sponsored programs such as the FDA’s workshop, along with industry partners and academic-directed efforts such as SCAI WIN and HDRC will spur innovation to address identified, but still unmet, needs of patients in the field of cardiovascular device research.”
To learn more about SCAI WIN, visit www.scai-win.org. For details about the Health Disparities Research Consortium, visit www.disparitiesresearch.org. Or contact Rebecca Ortega at email@example.com.