
Urgent Call for Women-Only Trials in Cardiac Surgery Gains Momentum
2025-01-29
Author: Arjun
LOS ANGELES, CA - Groundbreaking discussions have emerged around the critical need for women-only clinical trials in cardiac surgery, propelled by research indicating that women experience cardiovascular disease differently than men.
This disparity has sparked a call among experts for enhanced representation of women in clinical trials and a closer examination of the unique challenges they face in surgical settings.
Dr. Maral Ouzounian's Insights
Dr. Maral Ouzounian from Toronto General Hospital emphasized that the differences in disease pathology and treatment outcomes between men and women necessitate focused studies tailored specifically for women.
She articulated a pressing need to investigate the mechanisms behind these differences to improve outcomes for female patients.
Declining Participation in Trials
The alarming statistics shared during the recent Society of Thoracic Surgeons (STS) annual meeting revealed a decline in the percentage of women participating in cardiac surgery trials, plummeting from 30% in 2000 to around 20% in 2020.
Dr. Sigrid Sandner from the Medical University of Vienna highlighted that North American studies showed slightly better representation, but noted that a mere 1% of authors in cardiac surgery trials were women, underscoring a deep-seated gender disparity in clinical research.
Underrepresentation in Leadership
Unsurprisingly, the data shows women are not only underrepresented among trial participants but also in leadership roles.
A stark report from the Annals of Thoracic Surgery in 2023 revealed that out of 58 randomized trials analyzed, only eight were led by women.
The ROMA:Women Trial
The ongoing ROMA:Women trial, which focuses exclusively on women in coronary artery bypass grafting (CABG), has garnered significant interest.
This pioneering trial takes into account the distinct characteristics of female patients, such as a tendency to present at older ages with more advanced conditions, demonstrating how tailored trials can yield pertinent insights.
Recruitment Success
Dr. Sandner reported that the recruitment for ROMA:Women has exceeded initial expectations, prompting discussions around whether women-only trials could be more efficient than traditionally mixed-gender studies.
Many experts, including Dr. Gregory Hirsch, advocate for capitalizing on the potential ripple effects that gender-specific trials could have on improving female patient care, not just in surgical contexts but in overall treatment pathways.
Ethical Concerns
Concerns about the ethics of conducting trials segregated by gender arise, as noted by Dr. Justin Schaffer.
He urged a more inclusive approach that emphasizes diverse patient representation across ethnicities and other demographics.
Consensus for Women's Trials
Nevertheless, Dr. Joseph F. Sabik, incoming president of STS, and other panelists agreed on the necessity of focusing some research specifically on women due to inherent differences observed during surgical procedures.
They contend that in areas where sex-based differences are pronounced, the creation of dedicated studies for women is not just beneficial but essential.
Conclusion
In summary, the message reverberated through the session was clear: with cardiovascular health outcomes being notoriously different for women, the urgent need for dedicated women-only clinical trials is undeniable.
Experts assert that embracing these trials could pave the way for substantial improvements in healthcare for women, ensuring that treatment guidelines and practices are as effective for women as they are for men.
This critical evolution in cardiac research could signal the dawn of a more equitable era in cardiac care.