Medical Device Daily Washington Editor

WASHINGTON — Women suffering from cardiovascular disease outnumber men, according to the American Heart Association (AHA; Dallas).

It would make sense then that women must undergo more interventional procedures, right? Wrong.

Despite the known benefits of interventional procedures such as angioplasty and stenting in reducing heart attacks, only one-third of all patients treated with interventional procedures are female, the AHA says.

Tomorrow is the second annual “Go Red for Women“ day, encouraging people to wear red and designed to raise awareness that heart disease is the leading cause of death in women.

On Tuesday in New York, a panel of experts released a scientific statement that called for the need to improve treatment of female cardiovascular patients and provide earlier diagnosis and referrals to contemporary interventional cardiovascular therapies.

The AHA statement, published in the upcoming issue of the association's journal, Circulation, addresses the rising rate of mortality in women with cardiovascular disease and urges physicians to provide earlier referrals for percutaneous coronary interventions in women.

PCI, which includes balloon angioplasty and stenting to open blocked arteries, could prevent many coronary heart disease deaths in women each year, particularly in women who arrive at the hospital having a heart attack, according to the statement, titled “Percutaneous Coronary Intervention and Adjunctive Pharmacotherapy in Women.“

More than 1 million Americans undergo PCI each year, but only 35% of these procedures are performed in women, according to Alexandra Lansky, MD, chair of the statement writing group, director of the Women's Cardiovascular Health Initiative at the Cardiovascular Research Foundation and associate professor of clinical medicine at Columbia University Medical Center (both New York).

Lansky told Medical Device Daily that the reason that women are not as often referred for PCI is based on outdated information indicating that women experienced high death and complication rates as a result of these procedures.

Her hope is to draw awareness to the disparities in treatment, she said.

“This review finds that these procedures are not only safe and effective in women, but that outcomes continue to improve,“ she said. “Twenty years have now gone by, and the technology has clearly come a long way from balloons and devices that really didn't work in women.“

Lansky said older devices were larger, cumbersome and harder to maneuver in smaller vessels. “Today's stents and drug-eluting stents are designed for much smaller vessels and are negotiable down small vessels — which is particularly relevant for the female patient — and can be delivered in a much broader spectrum of lesions.“

While modern technology should pave the way for breaking down the referral bias, Lansky acknowledged that research does confirm that the female population may present some “unique problems.“

“There is no question that the female patient is likely to have a higher cardiovascular disease risk profile,“ she said. “Typically women who are referred for PCI have smaller vessels; they also have more diabetes and hypertension and are usually eight to 10 years older than men who are referred.“

She also said that women often delay seeking treatment, so much so that often when they have heart attacks they will seek help from 30 minutes to 60 minutes later than their male counterparts.

Lansky said those factors, rather than gender, contribute to a higher risk of death in women and should not keep women from having potentially life-saving treatments.

“A closer look at known clinical data reveals that it is these risk factors, and not gender per se, that is responsible for the poorer results in women. In fact, once women are referred for PCI, the rate of blood vessels being successfully re-opened is similar to that in men.“

The statement does not present specific recommendations for physicians but compiles the latest evidence about the effectiveness of PCI in women. The panel identified three important areas for improving women's treatment.

The first recommendation is in the area of diagnosis and early referral for treatment. Women face great delays for stenting or angioplasty, Lansky said. By contrast, men are usually promptly referred for these procedures for suspected cardiovascular disease. Lansky and her colleagues said the goal should be the same for women.

The statement also encourages further research to optimize therapy for patients with diabetes and small vessel coronary disease, two conditions prevalent among women.

Finally, the panel calls for more refined treatment pathways and strategies for women who have ST-elevation myocardial infarction, a type of heart attack where mortality rates and bleeding risk remain significantly higher than in men.

Noting that the new statement is based on analysis of gender-specific evidence compiled in clinical trials over the last two decades, Lansky said more such trials are needed.

“Our statement is based on the gender-specific evidence we have available to us as healthcare professionals,“ she said. “To truly improve outcomes in women, we need to recruit more women in future clinical trials, as female representation has been 38%, at best, and often closer to one-quarter of the studied populations.“

Before interpreting any clinical trial data, it is always important to examine all risk factors and attributes of a certain patient population, Lansky said.

Going forward, she said “it is important to show the cardiologists and the more general internists that these procedures are safe, save lives, prevent heart attacks and, hopefully, begin to change the referral pattern. It doesn't make sense to withhold these procedures in 2005.“

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