Stents Raise Death Risk for Heart Attack Patients

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By Eva von Schaper


A drug-eluting CoStar stent, made by Conor MedSystems Inc., a subsidiary of Johnson & Johnson, is pictured inside an artery in this undated company rendering. Source: Conor MedSystems Inc. via Bloomberg News.

Sept. 4 (Bloomberg) -- Drug-coated stents were linked to a higher death rate when given to people with a certain type of heart attack in a study, a finding that may limit doctors' use of the tiny mesh tubes to prop open arteries.

The heart attack patients died at more than four times the rate when they received a drug-coated device compared with patients who had received an older, bare-metal stent, researchers led by Philippe Gabriel Steg said today at the European Society of Cardiology meeting in Vienna. These patients should no longer be given drug-eluting stents, Steg said.

``This data is serious,'' Eckhart Fleck, the doctor who runs Germany's largest catheterization laboratory in Berlin, said in an interview. ``This will lead to more concrete indications for drug-eluting stents. Not everybody needs to have one.''

Boston Scientific Corp. and Johnson & Johnson have seen demand for their drug-coated stents fall since researchers in 2006 found an association between the devices and potentially fatal blood clots. The devices were shown to be safer than previously thought in a study released on Sept. 2 by researchers who examined all stent patients in Sweden.

Boston Scientific rose 37 cents, or 2.9 percent, to $13.20 at 4:01 p.m. in New York Stock Exchange composite trading. Johnson & Johnson rose 19 cents to $61.98.

Steg's study, part of a larger trial dubbed Grace, followed almost 2,400 heart attack patients for the two years after they had received either a bare-metal or a drug-coated stent. The death rate among drug-coated stent patients was 4.7 times higher when compared to those that had received bare-metal stents, Steg said. After some statistical adjustments, the risk was about six times higher for heart attack patients.

Narrowing Vessels

Heart attack patients may be especially vulnerable because the narrowing of blood vessels in response to the attack can lead to the wrong size and placement of the stent, producing a gap in which clots can form.

``Patients are now very wary about these stents,'' Steg said in an interview. ``Personally, I don't use these stents in heart attack patients any longer.''

The research is a type of observational study known as a registry, which limits the conclusions it can offer, cardiologists said. The Swedish study released in Vienna earlier this week was also a registry. A trial according to the highest standards of research may show an even greater death rate, Steg said.

The results are substantially different from other real world registry data, including the Swedish registry, that showed no increased risk of death among patient getting drug-coated stents, Christopher Allman, a spokesman for New Brunswick, New Jersey-based Johnson & Johnson, said in an e-mailed statement. The discrepancy can be explained by differences in recording patient death rates and variations in patient population between the two studies, Steg said.

Heart Attacks

The study examined the subset of patients with heart attacks that can be identified in an electrocardiogram. Other heart attack patients did not have an elevated risk of death.

About 1 million Americans suffer heart attacks each year, with 250,000 experiencing the most severe form that occurs when a clot completely blocks blood flow to the heart, according to the American College of Cardiology. Patients with that severe type were examined by Steg's research team for their study.

Stents are metal mesh tubes that keep arteries open after doctors have cleared clogged vessels with tiny inflatable balloons. To suppress growth of scar tissue that can block the blood vessel, device makers started coating stents with drugs used to suppress the immune system or prevent cell division.

To contact the reporter on this story: Eva von Schaper in Munich at evonschaper@bloomberg.net .

Last Updated: September 4, 2007 16:17 EDT

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