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Drug-eluting heart stents were approved by the Food and Drug Administration (FDA) in 2003 as an innovative solution to the problem of clogged arteries. They were considered to be a cut above their predecessors - bare metal stents made of wire mesh - which weren't as effective in keeping vessels open. Since their introduction, drug-eluting stents have been implanted into the hearts of more than 3 million American patients.
Unfortunately, the same drug-eluting stents that fuel a $5 billion-a-year market are now being blamed for potentially deadly side effects. Recent studies of patients who have had the devices for 6 months or longer report a 3 to 5 percent occurrence of severe blood clots which may lead to sudden heart attack. The American College of Cardiology website estimates that fatalities from drug-eluting stents may exceed 2,000 a year. This begs the question: Are these 'medical marvels' doing far more harm than good?
What is a Drug-Eluting Stent?
Unlike older stents which were made of bare metal, a drug-eluting stent is a more sophisticated form of the device. A disadvantage of bare metal heart stents is that although they eliminate abrupt artery closure, the body in time would grow scar tissue over the stent which would cause the artery to become clogged again. In contrast, drug-eluting stents are designed to inhibit growth of this tissue by releasing a special time-release medication, thereby reducing the chances that the artery will re-close. Patients with drug-eluting stents must also take anti-clotting or anti-platelet medication for 6 months or longer after stenting. These drugs help prevent stent thrombosis, a reaction to the device which causes a thickening of the blood in the newly expanded artery.
Drug-Eluting Stents: Unapproved Use
When the FDA approved drug-eluting stents, their use was intended primarily for simple blockages involving just one artery, where the patient has no significant damage to their heart. The devices were not approved for patients with a history of complex multiple blockages or severe heart attacks, although many doctors- an estimated 60% - still use them in such patients. Some experts feel that this type of 'off-label' use may further increase the adverse risks to stent patients. In these more complicated cases, there is uncertainty that the benefits of the devices outweigh the hazards.
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