One trial that may close the research gap is ROMA-Women. Mario Gaudino, MD, PhD (Weill Cornell Medicine, New York, NY), one of the principal investigators, said that while there are observational data to support multiarterial grafting over a single arterial graft, this is being put to the test in a randomized trial in the 4,000-patient ROMA trial. Moreover, it remains possible the treatment effect may vary by sex. However, with only a minority of female patients (approximately 15%), ROMA, which has completed enrollment, would be unable to detect meaningful differences between men and women.
Given that concern, investigators took advantage of existing site infrastructure and launched ROMA-Women. Speaking in the EACTS session, Gaudino provided an update on the trial’s progress, noting it recently gained support from the Global Cardiovascular Research Funding Forum, an international consortium of funders for investigator-led multinational trials. To date, the trial has enrolled more than 200 out of a planned 1,300 patients—not including the roughly 700 female participants in ROMA who will be rolled into ROMA-Women—since the trial launched 3 months ago.
That pace of enrollment is “better than expected,” said Gaudino. “If we keep this pace, we can make this impossible trial possible.”
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