ROMA-Women

Randomized comparison of the outcome of single vs. multiple arterial grafts in women (ROMA:Women)

The international clinical trial ROMA:Women is investigating how to optimize bypass surgery for women with coronary artery disease (CAD). This condition results from narrowed or blocked coronary arteries that supply the heart muscle with oxygen. As a consequence, patients may experience chest pain, or in the worst case, a heart attack. A bypass improves blood flow by using a vessel from the patient’s own body as a "detour."

The study’s leadership and central coordination for Germany are managed by Prof. Dr. Bernhard Danner, Executive Senior Physician at the Department of Cardiothoracic and Vascular Surgery at University Medical Center Göttingen (UMG), and Prof. Dr. Ingo Kutschka, Director of the same department at UMG. The German Centre for Cardiovascular Research (DZHK) is supporting the participating German study centers with a total of €518,000 over a period of nearly five years.

The trial compares the use of multiple arterial grafts—known as multiple arterial bypass grafting—with the standard therapy of a single arterial graft in women with CAD. The aim is to determine whether the choice of bypass technique yields better long-term outcomes and reduces the risk of major cardiovascular events such as heart attack, stroke, or the need for repeat interventions. Until now, there has been a lack of comprehensive data on which method provides the best long-term outcomes specifically for women. Findings from ROMA:Women are intended to enhance our understanding of sex-specific differences in cardiac surgery and to support the development of evidence-based treatment guidelines for women.

In total, 2,000 women worldwide are expected to be enrolled in the study, including 163 patients from Germany, whose participation is partially funded by the DZHK. The international coordination of the study is led by Prof. Dr. Mario Gaudino, Weill Cornell Medicine in New York, USA.

Publications

There are no publications yet.

Principal Investigators

Principal investigator for Germany: Bernhard Danner (Göttingen), Principal Investigator (Sponsor): Mario Gaudino (Weill Medical College of Cornell University), Co-PI for Germany: Ingo Kutschka (Göttingen)