New Study Looks at Coronary Disease in Women
Columbia Cardiologists lead EMPOWER CAD study
Women with coronary artery calcification (CAC) have been shown to experience poorer outcomes compared to men. Recent studies suggest that one treatment for CAC, intravascular lithotripsy (IVL) using the Shockwave C2 coronary IVL catheter device, produces similar safety outcomes for men and women, but the existing research fails to adequately represent the female CAC patient population. Columbia interventional cardiologist Margaret McEntegart, MD, PhD, is co-investigator for an upcoming study to determine if these earlier safety results can be replicated in an all-female population.
Women treated for coronary artery calcification (CAC) have been shown to experience poorer outcomes compared to men. And while some studies suggest that treating CAC with intravascular lithotripsy (IVL) produces similar safety outcomes for men and women, there has been very little research focused specifically on the female CAC patient population. To address this gap in knowledge, Columbia interventional cardiologist Margaret McEntegart, MD, PhD, will serve as a co-investigator for the upcoming EMPOWER CAD study to determine if these earlier safety results can be replicated in an all-female population.
McEntegart, director of the Complex Percutaneous Coronary Intervention Program at Columbia University Irving Medical Center/New York-Presbyterian Hospital, sees the study as an important opportunity to improve care for the female CAC population. “We know that when women have calcium in their arteries, it is an independent predictor of poor outcomes,” says McEntegart. “And we know when we try to treat the calcium, these patients are exposed to higher risk from the treatment. The idea that a device could provide effective treatment without exposing these female patients to excessive risk is quite an exciting prospect.”
What Is Coronary Artery Calcification?
CAC is a form of coronary artery disease (CAD) in which the arteries that supply blood to the heart become narrowed or blocked due to a buildup of calcium deposits within the arterial walls. These calcium deposits reduce the flow of oxygen-rich blood to the heart, which can lead to serious cardiac issues like chest pain and heart attacks.
Current data shows that women treated for CAC have poorer outcomes than men, but very little research has specifically focused on explaining this disparity. There is an immediate and unmet clinical need for determining the safest treatment strategy for women with CAC.
One promising treatment for CAC is intravascular lithotripsy (IVL), which uses a catheter inserted into a blood vessel in the arm or leg to deliver a balloon device to plaque in the coronary artery. The balloon is inflated to expand the artery while emitters within the device deliver controlled pulsatile waves to break up the calcium deposits into smaller pieces that can be more easily displaced to facilitate stent implantation.
While current studies suggest that IVL using the Shockwave C2 coronary IVL catheter produces similar safety outcomes for men and women, more research focused on the female CAC patient population is needed.
The EMPOWER CAD Study
This prospective study will enroll up to 400 female patients who require treatment of calcium in their arteries at up to 50 research sites across the U.S. and Europe and will include a three-year follow-up.
McEntegart will be joined as co-investigator by Alexandra Lansky, MD, director of the Heart and Vascular Clinical Research Program at Yale University School of Medicine. Nieves Gonzalo, MD, PhD, consultant interventional cardiologist at Hospital Clinico San Carlos in Madrid, will serve as the European lead investigator. The trial is sponsored by Shockwave Medical, Inc., the developer of the Shockwave C2 coronary IVL catheter device.
Addressing Gender Disparity in Cardiovascular Research
The study also serves to improve research representation of women in patient populations for cardiovascular disease. Despite women representing roughly half the general population—and despite heart disease being the number one cause of death in women—most cardiovascular research has focused on men. “There's a real shortage of data about how to manage female patients,” notes McEntegart. “So far, we've relied on extrapolated data from the male population and assumed that the way we've treated coronary disease in men will have the same outcomes in women. We're only recently becoming very aware of the fact that when you look into most of the trials, the inclusion populations are only about 10% to 20% females, even in contemporary studies. So we're still not including women in a lot of these big cardiovascular trials.”
Cardiologists are only just coming to terms with how this disparity has a fundamental effect on how they diagnose and treat their patients. “It’s interesting that as a female physician, at some point you realize that you’re also biased because you've been trained on data based on men. For instance, when we were at medical school, we were taught the classic symptoms for a heart attack: pain or pressure across your chest, around your back, down your left arm and up into your jaw. But we now understand that women don't always present like that. They often present with more subtle symptoms like breathlessness or fatigue.”
McEntegart feels strongly that addressing this research gap will benefit patients and providers alike. She hopes the EMPOWER CAD study is an indicator of things to come. “I think the fact that it's a female-only trial is quite a signal of intent,” says McEntegart. “Going forward, I think we have to start to drive appropriate levels of recruitment in bigger trials as well as doing some further female-specific trials where we think there's a difference in therapeutic safety or effectiveness between men and women. There's an expanding area of work for us to start to move into, and I think this trial is a fantastic start.”
- Interventional Cardiovascular Care
- Complex Coronary Care
- Women's Heart Center
- 5 Questions with Dr. Margaret McEntegart