Healthcare Industry News:  drug-eluting stent 

Devices Interventional Cardiology

 News Release - December 5, 2006

American Heart Association Statement on Use of Drug-Eluting Coronary Stents

DALLAS, Dec. 5 (HSMN NewsFeed) -- A coronary stent is a wire mesh tube used to prop open a previously blocked artery to the heart. The stent stays in the artery permanently, helps hold it open, improves blood flow to the heart muscle and relieves symptoms of chest pains. The artery with a stent, however, can gradually become blocked again. This process, called restenosis, often requires another procedure.

In recent years, because of the problem of restenosis in the original (bare metal) stents, new types of stents, called drug-eluting stents, have been developed. These stents are coated with drugs that are slowly released to help prevent restenosis. These stents were tested over periods of months to years, and have been approved by the U.S. Food and Drug Administration (FDA) for this purpose.

Several recent studies have raised concerns that drug-eluting stents may not be any more effective than bare metal stents, because of an increased risk of blood clots within the drug-eluting stents. Most of these recent data have been presented at major medical meetings and are just now being published. The FDA is expected to review these data and additional information regarding these devices in a public hearing on December 7 and 8.

There are two separate issues regarding the safety of drug-eluting stents which should be distinguished by patients and physicians. The first is well- established from a scientific standpoint. Patients who have had a stent procedure should take both aspirin and another drug that acts against platelets (most often clopidogrel) for periods of one to 12 months, depending on their particular circumstances and the type of stent. Existing joint clinical guidelines from the American Heart Association, American College of Cardiology and Society for Coronary Angiography Intervention include specific recommendations about this. Research published earlier this year has shown that many patients are not following appropriate anti-platelet therapy during the first year after their stenting, and that they are more likely to have heart attacks and die. It is very important that patients do not discontinue their anti-platelet therapy within the first year after stenting without consulting their treating cardiologist.

The second issue is less well established at this time. The suggestion has been made that blood clots within drug-eluting stents are more common at a later date (more than a year after stent placement) than with bare metal stents. There is conflicting data regarding the magnitude and significance of this difference. Some of the patients in these longer-term studies were no longer taking aspirin, which is usually indicated on a lifelong basis for all patients with known coronary artery disease. Additional studies will probably be required to define the risk of late blood clots in patients with drug- eluting stents and the appropriate therapy to prevent them. In the meantime, it is important that all patients who have undergone stenting procedures continue aspirin indefinitely. Additional therapy should be left to clinical judgment based on individual patient circumstances.

According to American Heart Association President Raymond J. Gibbons, M.D., F.A.H.A., "These recent reports have raised appropriate concerns regarding drug-eluting stents, and more research is needed to determine the long-term efficacy and safety of these devices. Until such information is available, patients should receive appropriate anti-platelet therapy according to existing practice guidelines wherever possible. This will usually require both aspirin and clopidogrel for periods of up to a year after stenting and aspirin indefinitely. Patients should not discontinue either aspirin or clopidogrel within the first year without consulting their treating cardiologist. We are collaborating with five other major medical organizations on an advisory which will appear shortly and will provide further guidance on this important issue."

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Source: American Heart Association

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