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Devices Interventional Cardiology

 News Release - December 12, 2006

Kaiser Permanente Reports New Data on Drug-eluting Stents

Advantage seen for use of clopidogrel up to one year after implantation but no demonstrable benefit thereafter

OAKLAND, Calif., Dec. 12 (HSMN NewsFeed) -- New data on the safety of drug-eluting stents (DES) were presented to the Food and Drug Administration last week by Kaiser Permanente physicians. Sparked by safety concerns over drug-eluting stents, the study looked at the increased risk of clotting when drug-eluting stents are used, and the amount of time the drug, clopidogrel, should be taken following placement of the these stents. The data presented is consistent with the final FDA recommendations made after the hearings.

Speaking before the FDA panel were David J. Magid, MD, MPH, a Denver-based emergency physician and medical director of the Kaiser Permanente Colorado Clinical Research Unit, and Ralph Brindis, MD, MPH, FACC, a California-based interventional cardiologist and the senior cardiovascular adviser for The Permanente Medical Group of Northern California. Dr. Brindis is also a clinical professor of medicine at the University of California, San Francisco, and chief medical officer of the American College of Cardiology's National Cardiovascular Data Registry. Collaborating with Dr. Magid in conducting the data analysis was Alan Go, MD, assistant director for clinical research at the Division of Research, Kaiser Permanente, Northern California, and associate professor of epidemiology, Biostatistics and medicine, University of California, San Francisco.

Researchers reviewed 4,195 Kaiser Permanente members who received one or more DES between January 2004 - June 2006, looking for patterns of drug-eluting stent use, the types and timing of adverse outcomes from the use of drug-eluting stents, conditions that could predict which patients might have these adverse outcomes, and the ideal length of time the drug clopidogrel should be taken following stent implantation. All subjects were followed, up to October 31, 2006, for outcomes of acute myocardial infarction or death. The health plan's electronic medical record, KP HealthConnect, played an important role in providing details on pharmacy usage and the ability to track drug usage and complications from the stent. Among the findings:

* The majority of patients received DES for a non-FDA-approved indication (which is consistent with community practice).

* DES implanted in lesions outside current FDA indications are associated with an increased risk of adverse events.

* Clopidogrel may be associated with a reduction in adverse outcomes in the 1-6 months past current recommended therapy with no significant protective effect thereafter.

A key question in the FDA hearing focused on prolonged use of the drug clopidogrel. "Data from Colorado suggests that patients may benefit from clopidogrel use beyond the currently recommended period of time but not indefinitely," said Magid. "We did see benefit of patients being on the medication for up to a year as opposed to just three to six months."

"Kaiser Permanente has embraced the use of drug-eluting stents since their approval by the FDA in 2003, and our physicians have been impressed with their clinical benefits and improvement in our patients' quality of life," stated Dr. Brindis. "However, the issue of the occurrence of late clotting in these drug-eluting stents -- even a low frequency -- may lead clinicians to decide that some small subsets of patients presently being treated with drug-eluting stents might be better managed with either coronary bypass surgery or bare metal stents."

About Kaiser Permanente

Kaiser Permanente is America's leading integrated health plan. Founded in 1945, it is a not-for-profit, group practice program headquartered in Oakland, Calif. Kaiser Permanente serves more than 8.6 million members in nine states and the District of Columbia. Today it encompasses the not-for-profit Kaiser Foundation Health Plan, Inc., Kaiser Foundation Hospitals and their subsidiaries, and the for-profit Permanente Medical Groups. Nationwide, Kaiser Permanente includes approximately 154,000 technical, administrative and clerical employees and caregivers, and more than 12,000 physicians representing all specialties.

Source: Kaiser Permanente

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