• March 2020

    Warrior trial seeks to reduce heart disease risk in women

Cardiovascular disease is the leading cause of death in US women. However, many women present with atypical symptoms of cardiovascular disease risk. They often go untreated and are not seen again until a life-threatening cardiac event occurs. Researchers at Baylor Scott & White Medical Center – Temple, TX are participating in a clinical trial aimed at helping these women.

Robert Widmer, MD, PhD, Cardiologist at Baylor Scott & White in Temple, notes, “Up to 40% of women who present with symptoms of ischemia do not have blockages in their coronary arteries, a condition known as non-obstructive coronary artery disease (NOCAD). These people are usually lost to follow-up due to a lack of definitive treatment guidelines for their signs and symptoms.”

NOCAD was thought for many years to be clinically insignificant. One reason why it goes unnoticed is the complex and relatively understudied mechanistic etiology of the disease. Endothelial and/or microvascular dysfunction, along with compensatory remodeling of the vessel, are thought to contribute to the disease state. There is also growing recognition of the importance of atherosclerotic plaque instability, rather than just overall extent of obstruction, in cardiovascular risk. Nevertheless, a 2016 meta-analysis of 48 studies, including 64,905 people, confirmed that NOCAD confers an overall greater risk of adverse cardiovascular outcomes.

Through Baylor Scott & White Research Institute (BSWRI), Dr. Widmer’s research team at Baylor Scott & White in Temple is participating in the Women’s IschemiA Trial to Reduce Events in Non-ObstRuctive Coronary Artery Disease (WARRIOR) trial. This multicenter, prospective, randomized, blinded outcome trial is testing intensive therapy compared to usual care in adult women who have symptoms of ischemia but do not have significant blockage of the coronary arteries.

According to Dr. Widmer, “Over 4,000 females will be randomized, making it one of the largest female-only trials in the world.”

The therapeutic approach consists of a high dose statin combined with an angiotensin receptor blocker or angiotensin converting enzyme inhibitor. For women without contraindications, aspirin is also recommended. The primary outcome of the trial is the occurrence of a major adverse cardiac event such as myocardial infarction, stroke, or heart failure.

The WARRIOR trial is notable for its emphasis on practicality and cost-effectiveness. Dr. Widmer mentions, “Some trials use very expensive and invasive tests for diagnosis and test expensive medications that often don’t work well. This trial aims to consider a wide variety of women and to use medications that are well-established, fairly inexpensive, and well-tolerated.”

Funded by the Department of Defense, the WARRIOR trial considers that because there are over 200,000 women in active military duty and over two million women veterans, it is a strategic priority to prevent major adverse cardiovascular outcomes that would limit military strength and increase healthcare cost burdens. Furthermore, military women are exposed to unique stressors during active duty, which can increase cardiovascular disease risk. The trial accepts both military and civilian women.

According to Dr. Widmer, “With this study, we hope to change the clinical practice standards. We really need to be alert when a female patient comes in with risk factors and atypical symptoms. It is important to ask a few more questions and ensure that we are not turning away someone who can benefit from therapy.”

Baylor Scott & White’s Heart Center in Temple is a comprehensive cardiovascular diagnosis and treatment center supporting patients throughout Central Texas. The Heart Center hosts a multidisciplinary team of specialists and is recognized for efficient intervention in cardiac emergencies by the Society of Cardiovascular Patient Care. In collaboration with BSWRI, full clinical trial support is available, including centralized recruiting through the BSWRI network and outreach to the diverse Central Texas population.

For more information about this study, contact Robert.Widmer@BSWHealth.org.