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Drug Coated Stents Take Another Hit, As Study Shows Bypass is Better

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More bad news for Drug Coated Stents.   According to a study in the New England Journal of Medicine, drug coated stents are not as effective a remedy for clogged arterys as traditional bypass surgery.

Stents are tiny wire-mesh tubes used to prop open arteries after doctors clear them of blockages. Some stents have a drug coating meant to keep vessels from re-clogging following procedures. The study looked at the newest kind of stents, those coated with drugs to keep arteries open, made by Johnson & Johnson and Boston Scientific Corp. in the U.S. Previous studies saw similar results with older, bare metal stents. Drug-coated stents were once a near $6 billion a year market, but that figure has fallen sharply amid concerns stents could cause complications. Some patients developed blood clots months after having the devices implanted so many doctors reverted to older and cheaper bare-metal stents. A previous study, conducted by Swiss researchers and with results released last year, stated expensive drug-coated stents are not worth using in many patients.

Drug Coated Stents are designed to prevent arteries re-narrowing as often happens with bare metal stents, but their use dropped due to fears that deadly blood clots can form inside the devices in rare cases. The findings are a result of an 18-month study of 826 patients and present a less favorable value-for-money picture than previous research and—as expected—stoked fresh controversy over when to use drug stents..

In stenting—a procedure introduced in the 1990s—doctors thread a stent up through a small incision in the leg, widening clogged arteries instead of replacing them. Following stenting, a patient can be back up, around, and working the next day. When undergoing the open-heart surgery of a bypass, recovery takes weeks. Because of this, bypass surgeons have been left to treat only the most severe cardiac cases. The number of bypass surgeries has declined and recently leveled at about 300,000 procedures in the U.S. last year as compared to about a million stentings in the same period.

But stenting may not offer permanent benefits. In this week’s study, University at Albany physicians reviewed patients who received a stent or bypass in New York State in 2003 and 2004, comparing rates of death and heart attacks. Death rates between the procedures didn’t differ; however, after adjusting for risk, substantial differences were found. Those with two clogged arteries who received a bypass had a 29% lower death rate over the next 18 months than those who received stents. For the sickest patients—those with three clogged arteries—surgery provided a 20% lower death rate.

While the findings are not likely to settle the ongoing dispute between cardiac surgeons, who perform bypasses, and the interventional cardiologists who implant stents, it does provide additional fodder to those who argue that stents are overused.

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