Up to 6.5 million US women could benefit from new heart health advance

09/23/04

Sirolimus-eluting coronary stent significantly reduces incidence of reblocked heart arteries in women, including diabetics and smokers

Miami, FL (Sept. 23, 2004) – An integrated analysis of data from multiple clinical trials demonstrates that female patients who received the CYPHER® Sirolimus-eluting Coronary Stent are five times more likely to avoid a repeat reblockage in the treated arteries than women treated with a bare metal stent, according to Cordis Corporation, a Johnson & Johnson company. Benefits were also seen in women with increased risks of heart disease due to diabetes and/or smoking. While extensive clinical data prove that the CYPHER Stent is helpful for a wide variety of patients with heart disease, this is the first data analysis to focus exclusively on the CYPHER Stent's effectiveness in women.

"There has been no definitive analysis focused exclusively on the impact of drug-eluting stents on women," said Cindy L. Grines, MD, Director of the Cardiac Catheterization Laboratories, William Beaumont Hospital, Royal Oak, Michigan. "This is significant because heart disease is the main killer of women in the United States, regardless of race, and most women don't even know it. The data may help us better treat our female patients with heart disease."

Among the female patients evaluated in the trials, only 3.5 percent of women treated with the CYPHER Stent needed to have the same artery blockage re-treated (known as target lesion revascularization or TLR), compared to 15.3 percent of women treated with a bare metal stent, which is a type of stent that is not coated with a drug. The broad analysis, which involved 345 women, evaluated the safety and effectiveness of the CYPHER Stent.

"When using stents, there's often the possibility that a physician will have to subsequently re-intervene to fix a lesion that re-closes or, more simply put, gets reblocked. A low target lesion revascularization rate means that fewer women had to endure another procedure and that is great news for patients and their families," said Dr. Grines.

The comparative look at the female population in the studies found that women (average age 66), including some in high-risk groups, such as those with diabetes (28 percent of the sample) and current smokers (21 percent of the sample), benefited from treatment with the CYPHER Stent, specifically in terms of reducing major adverse cardiac events (MACE) such as death or heart attack. The analysis also showed that in terms of MACE rates, women and men had similar results (women – 5.8 percent vs. men – 6.6 percent).

The integrated analysis encompasses several key clinical trials in the CYPHER Stent program, including two that were submitted for marketing approval in Europe (RAVEL Trial) and the U.S. (SIRIUS Trial), as well as the DIRECT Trial, the SVELTE Trial, and New SIRIUS.

Women Are Regularly Misdiagnosed/Underdiagnosed for Heart Disease

Women are routinely under diagnosed and under treated for heart conditions, the number one cause of death among American women. According to government statistics, about 6.5 million American women have heart attacks or experience chest pain annually and two-thirds of American women who have had a heart attack don't make a full recovery.

According to the National Heart Lung Institute, despite availability of innovative and minimally invasive therapies for treating blocked arteries, such as the CYPHER Stent, women tend to be under diagnosed and treated for heart conditions. While heart disease is the number one killer of women, only 13 percent of women recognize that heart disease is their greatest health risk.

"As doctors we need to be aware that heart disease is a condition that is frequently misdiagnosed or overlooked among women and we need to ensure that we are looking at all effective treatment options especially those that are less invasive than open heart surgery and provide a faster recovery time," Dr. Grines said. "Data reviews, such as this one, provide an opportunity to bring to light the problem of heart disease in women, and how new medical advances are helping women live fuller, healthier lives."

CYPHER Stent: The First U.S. Approved Combination Drug-Device To Reduce Restenosis

In April 2003, the Cordis Corporation received FDA approval to market its CYPHER Sirolimus-eluting Coronary Stent, making it the first drug-eluting stent to be approved in the United States for the treatment of restenosis, also known as reblockage, of the arteries. Overall, more than five million Americans are treated each year for coronary artery disease -- blockages in the vessels that supply oxygen and vital nutrients to the heart muscle. Approximately 1.1 million people undergo balloon angioplasty, with approximately 80 percent of those receiving a coronary artery stent. Of the patients who are treated with these and other therapies, 15 to 20 percent (150,000 – 200,000 people) develop restenosis, or re-blockage of the treated artery, and have to undergo one or more repeat procedures to keep the artery open.

The CYPHER Stent combines the action of a stent – which works like a scaffold to keep the artery propped open–with delivery of the drug Sirolimus into the vessel wall to prevent restenosis, or reblockage, of the artery. Unlike open heart surgery or other more invasive medical procedures, with the CYPHER Stent a cardiologist inserts the stent using a guiding catheter through a small incision in the femoral artery, into the blocked artery where it is deployed.

About the CYPHER® Stent

Developed and manufactured by Cordis Corporation, the CYPHER® Stent is currently available in more than 80 countries and has been used by doctors to treat more than 900,000 patients worldwide. With more than 40 clinical trials conducted or in progress worldwide, the CYPHER Stent remains the most studied drug-eluting stent today with the largest body of clinical evidence demonstrating the long-term safety and efficacy of its drug and polymer. In clinical trials, the CYPHER Stent has been shown to reduce reblockage in the arteries by more than 90 percent over a conventional bare metal stent. More information about the CYPHER® Stent can be found at www.CYPHERusa.com.

Source: Eurekalert & others

Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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