Medical Device Daily

PARIS – The rather obvious differences between men and women are, well . . . rather obvious.

And they should be most obvious to those in healthcare. But beyond their clear-cut differences in anatomy, child-producing and a variety of late-in-life alterations in physiology, men and women seem to be lumped together in a sort of one-gender-fits-all type of approach in healthcare delivery, an approach that is becoming both increasingly clear and increasingly discussed in the realm of cardiovascular treatment.

Overlaying this is the ongoing search for the perfect patient – or at least those patients who will best represent the best results of clinical research, a theme that seemed to reach the near-obsessive level at this year's edition of EuroPCR.

These issues were put under a very bright spotlight during a Wednesday morning session titled “Cardiovascular intervention in women,” with a series of speakers (all but one and the session chair being men) reviewing a variety of research into how cardiovascular care addresses the two genders, key differences between the genders in the research concerning the most advanced cardiovascular technologies and the need for increased investigation into these issues.

And the conference as a whole, in terms of the many research presentations and summaries, demonstrated that men outnumber women two-to-one, three-to-one or even more in this area of clinical study.

Ghadha Mikhail, MD, a cardiologist at North West London Hospitals and St. Mary's Hospital Trust (both London) and the session's chairwoman, provided some key perspectives for the presentations by noting that women generally “present” differently in terms of heart disease, and present later, so that they may have more serious disease and more, or more serious, co-morbidities. The result will tend to be exclusion from trials. And on the morphological side, women frequently have “smaller vessels,” she said, that make them more difficult to treat and therefore more excludable.

The first presenter was the well-known cardiologist Eberhard Grube, MD, chief of cardiology, Siegburg Heart Center (Siegburg, Germany), who discussed whether or not the use of drug-eluting stents (DESs) provided different outcomes for men and women.

Rather tellingly, Grube preceded his presentation with the disclosure that he “had not looked into” this question previously and therefore had done some cramming in the form of “intensive research” into the subject in order to prepare for his presentations.

Grube provided an overview of the effectiveness of DES uses and their generally positive outcomes, resulting in a 90% penetration of the stent market. And while he said the effectiveness of DES devices was the same in women as in men, he noted that their use tended to come later in the therapeutic process because of slower referral to diagnostic catheterization and thus greater delay in intervention.

Thus he noted a “gender bias” in that more men than women received percutaneous coronary intervention (PCI) and that women were “less often referred to surgery than men.”

He noted also the “increased in-hospital mortality of women undergoing elective and primary PCI as compared with men, although not consistently observed.” Not attributing this to direct gender bias, he said it was likely the result of a” complex interplay of clinical factors such as delayed onset of disease, older age, smaller body surface area, and co-morbidities at the time of presentation.”

“Once women are referred for cardiac catheterization, revascularization is similar,” he said.

As to DES use, he noted some trials indicating even better results in women than men but said “more data are needed.”

And in giving a more general perspective, he said that women may feel they are “somehow more protected” against heart disease than men.

David Antoniucci, MD, of Careggi Hospital (Florence, Italy) provided an overview of what he called a key “paradox” in the treatment of men and women in terms of deaths from heart disease – that more women than men die in the hospital as a result of cardiovascular disease and its complications up to age 80 and then thereafter the pattern reverses.

As to whether there is any differential in the treatment of women and men via primary angioplasty, he found no significant differences. His advice to the cardiologist attendees: “Do it, it works.”

Vassili Voudris, MD – on the subject of “Angioplasty or surgery for coronary heart disease: what is best for a woman?” – served to further underline the effectiveness of PCI for women. While he noted some research indicating a higher rate of mortality for women after the procedure, an adjustment taking into consideration the larger numbers of vasculature complications among women indicated “similar” mortality.

As to the effectiveness of coronary artery bypass grafting procedure (CABG), he said the data indicated more cardiac readmissions for women at one year, but afterwards, “no difference in survival” between men and women.

Overall, he suggested better CABG outcomes for men than women in terms of quality of life because of better overall health going into the procedure. But he, like the other presenters, noted the need for serious randomized trial efforts to clarify this issue.

Alexandra Lansky, MD, of the Columbia University Medical Center (New York), reviewed the use of various drug regimens in connection with cardiovascular procedures and noted “higher complications rate for women,” especially in higher-dose regimens. She recommended the need for greater “dose selectivity” for women because of inherently higher risk, especially “the greater risk of bleeding.”

Being a woman, she said, is “an independent predictor of bleeding.”

And the lack of sufficient care in this regard she attributed to “biases, not physiology.”

Addressing the area of stroke and the use of carotid stenting, Bernhard Reimers, MD, of Mirano General Hospital (Mirano, Italy), reported “more higher-grade stenosis” and “very much more complications” in women but a better response to drug therapy than men. And he advised a more aggressive approach in treating asymptomatic women.

As an overview statement, he said that “females are always under-represented in clinical trials.”

That message came through pretty redundantly during this session, but Medical Device Daily wondered, why the later, delayed presentation of heart disease in women? What is behind this? Is this a clinical problem, or social?

“Both,” Mikhail told MDD.

Women's symptoms look different than those of men, she said, so that men's symptoms are more quickly identified as cardiovascular-based. And women are more often likely to delay seeking out treatment as a result of other responsibilities, and those same responsibilities may also result in delayed followup.

Because women are “grossly under-represented” in cardiovascular studies is “why we're here today,” she said. “We have to address gender analysis.”