* Research suggests devices work as promised
* New study provides 'lot of reassurance'
By Gene Emery
BOSTON, May 6 Heart stents coated with drugs
are just as safe as uncoated ones and appear to keep blood
flowing to the heart muscle longer, dispelling earlier concerns
about their safety, Swedish researchers said on Wednesday.
A study by the same researchers in December 2006 found
people who got the so-called drug-eluting stents were 18
percent more likely to die within three years.
That sent sales of the devices, made by Boston Scientific
(BSX.N) and Johnson & Johnson (JNJ.N), into a tailspin.
In September 2007, the Swedish team reported the safety
difference between drug-eluting and bare-metal stents had
evaporated. But the damage had been done as sales had slumped
by $1 billion.
Now, long-term results from the study, led by Dr. Stefan
James of Uppsala University Hospital in Sweden and published in
the New England Journal of Medicine, confirm that the risk of
death or heart attack is no greater among those who got
drug-eluting stents or older, bare-metal stents.
Stents are tiny, mesh tubes used to prop open diseased
heart arteries. Drug-eluting stents have medicine added to them
to prevent scar tissue from clogging up the device, a common
problem with the older, bare-metal variety.
Results from the Swedish study of nearly 48,000 patients
now suggest the devices work as promised, especially in
high-risk patients, who had a 74 percent lower risk of having a
clogged stent compared with similar patients who got a bare
Professor Franz Eberli from the University Hospital Zurich
in Switzerland, said the original study caused "a huge fire
storm" when it was first presented at a cardiology meeting in
Barcelona in 2006.
"The immediate impact was a decrease in the use of
drug-eluting stents and a lot of scrutiny on safety," he said
in a statement. Eberli said the latest paper looking at the
same group of patients "provides a lot of reassurance."
A smaller study in the same journal looking at how the
devices performed in heart attack patients showed no difference
in the risk of death or heart attack.
That study found the drug-eluting stent did a better job
than bare-metal stents of keeping blood vessels flowing
"Our study is in the highest-risk patients and it's a
randomized trial. The Swedish study is important because it's a
'real-world' study that included all comers," Dr. Gregg Stone
of Columbia University Medical Center said in a telephone
Stone's study, supported in part by a grant from Boston
Scientific, involved 3,602 people at 123 medical centers in 11
countries who used the company's Taxus-brand stents.
At the 13-month mark, 10 percent of the blood vessels held
open by the Taxus stents had clogged up by at least 50 percent,
compared with 23 percent of the instances where the bare stents
The drug-eluting stents cost significantly more than the
older uncoated stents, even though they do not seem to help
people live longer, at least not in the short run.
(Editing by Julie Steenhuysen and Peter Cooney)