With increased publicity targeting women, the distaff side of the population is beginning to realize that heart disease is as much a threat to them as men and a greater threat then headline-grabbing breast cancer. A key issue in this effort is highlighting the different, often more subtle ways in which heart disease evinces itself and heart attacks strike women. On top of this is the well-documented fact that women are decidedly under-represented in clinical trials.
Serving to focus on both of these issues is a study being launched by Abbott Vascular (Redwood City, California) to examine the specific effects of drug-eluting stents (DES) in women — and as an additional benefit to the company, providing more evidence concerning its Xience stent, currently under PMA review by the FDA. Abbott will assess the performance of its Xience V Everolimus Eluting Coronary Stent System in women with its XIENCE V SPIRIT WOMEN clinical trial.
It 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.
The company in mid-July 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.
Some wrong assumptions?
“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,” Krishna Sudhir, MD, a cardiologist who is medical director for global clinical science at Abott Vascular, told Cardiovascular Device Update. “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.
Sudhir suggested that physicians see the symptoms of heart disease experienced by men as typical, and that they consider as the symptoms of heart disease experienced by women as “atypical,” thus making diagnosis difficult. While men experience sudden violent chest pain or uncomfortable pressure or fullness, omen tend to have more subtle symptoms such as fatigue, pain in the jaw or shortness of breath. Though women die of heart disease at least 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 WOM-EN trial so important, Marie-Claude Mor-ice, MD, Institute Jacques Cartier (Massy, France), and principal investigator for the trial, told CDU in a phone interview from France.
Important because the first
“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% of those trials ... [B]ecause women are under-represented, the results can not be extended to women.”
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.
Adding to five others
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 on line – and generally predicted to gain leading market share among the second-generation DES products set to win approval over the next six to 12 months. The trial 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.
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, said that has not yet been confirmed but that the company is “looking into it.”
Abbott supplies a private-labeled version of the stent to Boston Scientific (Natick, Massachusetts), called the Promus Everolimus Eluting Coronary Stent System, as part of a distribution agreement established between the two companies last year as part of Boston Scientific’s deal to acquire Guidant (Indianapolis).