Leaders in heart disease treatment gathered in Washington, DC, last week to discuss gender disparities in women with heart disease and how the efforts of physicians, trialists, and patient, regulatory and industry groups can be harnessed to improve treatment outcomes in women. The inaugural Gender Data Forum was presented by the Society for Cardiovascular Angiography and Interventions-Women in Innovations (SCAI-WIN) program and the American College of Cardiology (ACC) and was moderated by WIN Program Chair Roxana Mehran, M.D., FSCAI, FACC.
The forum,designed to be the start of a series, focused on acute coronary syndromes (ACS) and acute myocardial infarction (AMI). Subsequent events will address specific aspects of improving health outcomes in women with cardiovascular disease. Last week’s forum will be the basis for development of a white paper and for heart disease treatment in women.
“I can’t even begin to say how excited I am for this first and rare opportunity to have all of you here today….to bring clinical trialists and experts from around the world together to discuss and analyze the data from their trials. We’ll be diving deeply into the data and bringing forth the data as it relates to women,” Dr. Mehran said as the forum kicked off. “This effort is really an attempt—and I think it is only an attempt—to answer some of the lingering questions related to sex disparities in cardiovascular outcomes.”
The day-long program began with presentations of published and unpublished data from trialists of past and current ACS and AMI clinical trials. Attendees discussed trends in the data around women and heart disease. In some cases, discussion centered on findings that did not reach statistical significance, perhaps because of the size or focus of the study, but that nonetheless may point to areas of interest for further research. Themes that emerged through analysis and discussion included women’s heart disease mortality rates, comorbidities, medication dosages and reactivity, bleeding complications, underrepresentation in clinical trials, and net clinical benefit of treatments.
In afternoon break-out sessions, attendees formed working groups to develop concrete ideas about how to carry the lessons of the data into practice. Physicians and trialists comprised one group, while patient, professional, regulatory and industry organizations formed the other group. The recommendations of these groups were then shared with all attendees.
“This is only the beginning,” said Dr. Mehran. “This is the first data forum and our big goal is to actually continue to move in this direction and ask trialists to come forth with their data and find ways to be able to assess safety and efficacy across the board….this is a huge, huge task and initiative we are undertaking.”
Data presenters at the forum included Cindy Grines, M.D., Steen Husted, M.D., Jessica Mega, M.D., Shamir Mehta, M.D., Matthew Price, M.D., FSCAI, Roxana Mehran, M.D., FSCAI, Kristin Newby, M.D., FSCAI, David Kong, M.D., FSCAI, Deepak Bhatt, M.D., FSCAI, and Eva Swahn, M.D. Participating organizations included WomenHeart, FDA Division of Cardio Devices, AstraZeneca, and The Medicines Company. The forum’s steering committee consisted of Roxana Mehran, M.D., FSCAI, FACC, Alaide Chieffo, M.D., FSCAI, Laxmi Mehta, M.D., FACC, Dipti Icthhaporia, M.D., FACC, and Karen Smith, M.D., FSCAI, FACC.
Watch for further coverage of this event and news about publication of the white paper in SCAI News & Highlights and on this website.