UF awarded $14.9 million Pentagon grant to study nonobstructive coronary heart disease in women

The Department of Defense has awarded a $14.9 million grant to the University of Florida to study a type of heart disease that disproportionately affects women, a growing segment of the U.S. military’s ranks.

Defense officials have heightened concern about nonobstructive coronary artery disease, with women comprising nearly 18 percent of active duty military personnel.

Although coronary artery disease, or CAD, is recognized as a killer, its nonobstructive counterpart was once considered a benign condition because patients suffered chest pain without arterial blockages that deny blood flow to heart muscle. These patients were typically offered little if anything in the way of treatment.

In recent years, however, studies have shown women and men with nonobstructive CAD are at increased risk of life-threatening cardiovascular events. And with repeated hospitalizations and testing, they increasingly consume health care resources.

The grant allows UF to spearhead a four-year, multicenter clinical trial to determine whether aggressive treatment of nonobstructive CAD with medication and lifestyle modification will reduce the likelihood of stroke, heart attack, heart failure, hospitalization and death. The trial is called WARRIOR, or the “Women’s IschemiA TReatment Reduces Events In Non-ObstRuctive CAD.”

“The prevailing notion was that those individuals with nonobstructive CAD on coronary angiography did not have a problem,” said cardiologist Carl J. Pepine, M.D., MACC, a UF professor of medicine and former chief of the division of cardiovascular medicine. Pepine is the principal investigator. Other principal investigators include Eileen Handberg, Ph.D., a research professor in the UF College of Medicine’s division of cardiovascular medicine, and Rhonda Cooper-DeHoff, Pharm.D., an associate professor in the UF College of Pharmacy and the division of cardiovascular medicine.

“They had a benign outcome and they could go about their life and were dismissed from care in general,” Pepine added. “What we’ve learned the last few years is that this is not true. It’s clearly not a benign syndrome.”

Researchers will recruit 4,422 women from 50 sites, including the Department of Veterans Affairs and active duty military hospitals and clinics through the OneFlorida Clinical Research Consortium. That recruitment will focus primarily on active-duty personnel, veterans and dependents living in Florida. Cedars-Sinai Medical Center in Los Angeles will provide some administrative support.

Women will be enrolled in the trial for 15 months and then be tracked for up to three years, with half receiving aggressive treatment with medication, including aspirin, a potent statin and an ACE-inhibitor. The other half will receive no structured care, which has been the traditional approach.

Study results will provide the data necessary to inform future guidelines on how best to treat the growing number of women with nonobstructive CAD, Pepine said.

“Current U.S. practice guidelines do not provide recommendations for this group of people,” Pepine said. “And that is the reason why they’re often dismissed from care. So, because this occurs so much more frequently in women and because women are the most rapidly growing minority group in the military, we decided to seek funding from the Department of Defense.”

Pepine said about 60 to 70 percent of women who are referred for coronary angiography after complaining of chest pain and other symptoms are eventually diagnosed with nonobstructive CAD, or even no cardiovascular disease at all. (The number falls to 10 to 20 percent for men.) That amounts to at least 250,000 women annually, according to one National Institutes of Health-funded project, the Women’s Ischemia Syndrome Evaluation, or WISE study, in which UF participated.

The financial burden of nonobstructive CAD’s complications can be immense. A UF study estimated the lifetime costs of treating such patients at more than $750,000.

“It’s a novel study,” said Pepine. “It’s the first study to intensively treat such individuals.”