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ROMA:Women

ROMA:Women

Sigrid Sandner (ORCID: 0000-0003-4669-9841)
  • Grant DOI 10.55776/KLI1147
  • Funding program Clinical Research
  • Status ongoing
  • Start September 1, 2023
  • End August 31, 2027
  • Funding amount € 357,208
  • Project website
  • E-mail

Disciplines

Clinical Medicine (100%)

Keywords

    Coronary Artery Bypass Grafting, Multiple Arterial Grafts, Single Arterial Graft, Women, Quality Of Life, Major Adverse Cardiac And Cardiovascular Events

Abstract

Coronary artery disease is the most common type of heart disease and a leading cause of death worldwide. Coronary bypass surgery is the standard of care to treat advanced coronary artery disease. During coronary bypass surgery, arteries or veins harvested from the chest, arms, or legs, called grafts, are used to bypass the blockages in the coronary arteries that reduce the blood flow to the heart muscle. Over the past two decades, coronary bypass surgery has become safer, with lower operative mortality and fewer perioperative strokes, and it has increased life expectancy for patients with coronary artery disease and improved their quality of life by alleviating symptoms of chest pain, shortness of breath, and reduced physical function. As a means of continuously improving the outcomes of patients undergoing coronary bypass surgery, studies in cardiac surgery are aimed at identifying which type of graft has better patency and offers better long-term survival - arteries or the traditionally used vein. A large ongoing multicenter randomized clinical trial (the Randomized comparison of the Outcome of single vs Multiple Arterial grafts - ROMA trial) will clarify this important question results are expected in 2026. The next clinical challenge we must meet is how to improve outcomes of coronary bypass surgery for women. Most of what we know about treatment of coronary artery disease comes from studies that included prevalently men. Thus, our current diagnostic and treatment algorithms are based on how the disease presents itself in men, not in women, who often have different symptoms. As a result, women are diagnosed later in life compared to men and are referred for coronary bypass surgery at an older age, and at this point more frequently have accompanying diabetes, hypertension, and dyslipidemia. From a surgical perspective, the operation is more complex in women because they have both smaller coronary arteries and smaller bypass grafts than men. Over the course of the last three decades women have consistently had higher mortality and worse outcomes after coronary bypass surgery (and any other coronary intervention) than men. Women represent on average only 20% of patients included in cardiac surgery trials (and ROMA is no exception). The results obtained in men, however, may not apply to women and thus misinform surgical decision making in women. ROMA:Women,thefirstcardiac surgery clinicaltrialdedicatedto women (https://clinicaltrials.gov/ct2/show/NCT04124120) has been designed to answer the question of which is the best type of graft in coronary bypass surgery for women. This innovative study has been endorsed by the Global Cardiovascular Research Funders Forum Multinational Clinical Trials Initiative (https://www.nhlbi.nih.gov/funding/global-cardiovascular-research/multinational- clinical-trials). https://weillcornell.org/mariogaudino https://www.theromatrial.com/about-roma/

Research institution(s)
  • Medizinische Universität Wien - 50%
  • Medizinische Universität Innsbruck - 17%
  • Cardiovascular Surgery - 9%
  • Universität Linz - 9%
  • Medizinische Universität Graz - 15%
Project participants
  • Daniel Zimpfer, Medizinische Universität Graz , associated research partner
  • Elfriede Ruttmann-Ulmer, Medizinische Universität Innsbruck , associated research partner
  • Andreas Zierer, Universität Linz , associated research partner
  • Bernhard Winkler, Wiener Gesundheitsverbund - Klinik Floridsdorf , associated research partner
International project participants
  • Mario Gaudino, Cornell University - USA

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