When it comes to women’s health, diseases such as breast cancer tend to get the lion’s share of the headlines.
So many women would be surprised to learn that the rate of death from heart disease is 18 times higher in women than breast cancer, says Krishna Sudhir, MD, a cardiologist and the medical director for global clinical science at Abbott Vascular (Redwood City, California).
Abbott — along with other companies and organizations focused on heart disease — is trying to increase understanding of this basic fact ... and how heart disease affects women. In this case, Abbott will assess the performance of its Xience V everolimus eluting coronary stent system in women with its XIENCE V SPIRIT WOMEN clinical trial.
Abbott says it is the world’s first clinical trial designed to study the safety and effectiveness of drug eluting stent (DES) treatment in women.
The company last week reported enrollment of the first patient in the trial, with Liliana Grinfeld, MD, of the Hospital Italiano (Buenos Aires, Argentina), performing the first procedure.
The trial will include roughly 2,000 women from about 100 sites throughout Europe, Asia-Pacific, Canada and Latin America, making it the first large interventional study on how cardiovascular disease differs in women from men, according to Abbott.
The trial will focus on specific aspects of women’s health in relation to coronary artery disease such as general awareness about the disease, symptoms at time of presentation, referral patterns, and hormonal menopausal status, the company said.
“Women have been under-represented in a number of clinical trials ... a lot of the assumptions that we make concerning cardiovascular disease in women come from trials where they have been under-represented,” Sudhir told Medical Device Daily. “So we thought this was the appropriate moment in time to design a trial exclusively for women [and by doing so] we would be obtaining a lot of new information on the behavior of stents in women.”
“I think it will call attention to cardiovascular disease in women. It is not recognized in the physician community or women patient community that cardiovascular disease is the leading cause of death in women,” Sudhir said.
The symptoms of severe cardiovascular disease are different for men and women. Men, for example, tend to have the more commonly-recognized symptoms such as sudden violent chest pain or uncomfortable pressure or fullness. Women tend to have more subtle symptoms such as fatigue, pain in the jaw or shortness of breath.
And since these symptoms tend to be atypical, women’s heart disease is more difficult to diagnose, Sudhir said.
Though women die of heart disease as often as men, women receive only 33% of angioplasties, stents and bypass surgeries; 28% of implantable defibrillators; and 36% of open-heart surgeries, according to Abbott.
That’s what makes the XIENCE V SPIRIT WOMEN trial so important, Marie-Claude Morice, MD, Institute Jacques Cartier (Massy, France), and principal investigator for the trial, told MDD in a phone interview from France.
“It is very important because it’s simply the first one to offer this particular treatment in only women,” she said. And she said that women “are never represented in clinical trials more than 25%-30% those trials ... [B]ecause women are under-represented, the results can not be extended to women.”
As the first trial designed to investigate DES treatment exclusively in women, Morice said XIENCE V SPIRIT WOMEN has the potential to enhance access to therapy for women by increasing the awareness of both physicians and women about cardiovascular disease.
The trial will evaluate patient and disease characteristics specific to women such as menopausal status and hormonal profiles, as well as treatment outcomes, including death, heart attack, the need for re-treatment, and potential risk of stent thrombosis, Abbott said.
XIENCE V SPIRIT WOMEN represents the sixth study in the company’s SPIRIT clinical trial program for the Xience DES which is currently being evaluated by the FDA as one of the next second-generation stents to come online. And it will increase the number of patients being studied in the SPIRIT family of trials to about 10,000. Abbott completed its premarket approval submission of the stent system to the FDA in June (Medical Device Daily, June 4, 2007).
The other studies evaluating the Xience V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease are: SPIRIT FIRST, a randomized trial comparing the stent system with the Multi-Link Vision metallic stent system; SPIRIT II, a randomized clinical trial evaluating Xience V vs. the Taxus from Boston Scientific (Natick, Massachusetts) in Europe and Asia Pacific; SPIRIT III, a large-scale randomized pivotal clinical trial comparing the stent to Taxus in the U.S. and Japan; SPIRIT IV, a randomized trial enrolling patients and will evaluate the safety and efficacy of the stent system for the treatment of coronary artery disease in a more complex patient population in the U.S.; and SPIRIT V, an international clinical trial enrolling patients that will provide additional data on clinical experience with Xience V at 100 clinical sites throughout Europe, Asia Pacific, Canada and Latin America.
In these earlier trials, the Xience V stent showed superiority to the bare metal stent and to the Taxus, Sadhir noted.
Xience V was launched in Europe and Asia Pacific in 2006. The stent is currently an investigational device in Japan as well as the U.S.
Asked if the trial would be expanded to enroll patients in the U.S., pending FDA approval, Karin Bauer Aranaz, a spokeswoman for Abbott Vascular, told MDD that “we have not confirmed that yet,” but that the company is “looking into it.”
Abbott supplies a private-labeled version of the stent to Boston Scientific, called the Promus everolimus eluting coronary stent system, as part of a distribution agreement established between the two companies last year.
Abbott Vascular, a division of Abbott Laboratories (Abbott Park, Illinois), offers vessel closure, endovascular and coronary products that are recognized internationally for their safety, effectiveness and ease of use in treating patients with vascular disease.