i'm really very very surprised by the date on this one!  i read about this
at least a year ago, or maybe two.

kate

Patients With Drug-Coated Stents to Hold Arteries Open Face Risk of
Blood Clots
December 5, 2006           14:40
By ANDREW BRIDGES

WASHINGTON --  Patients implanted with drug-coated stents to hold open
their choked arteries face a small but significant risk of blood clots,
health officials said Tuesday, and a new study recommended they take
clot-busting medications indefinitely.

Growing concerns about the long-term safety of drug-coated stents comes
to a head this week, when the Food and Drug Administration convenes a
two-day meeting to discuss clotting risks associated with the devices.

In documents released Tuesday, the FDA said it is unknown whether there
is an increased risk of death or heart attack in patients fitted with
the so-called drug-eluting stents. However, those patients do face an
increased risk of blood clots a year or more after surgery compared
with those fitted with bare-metal stents, the agency said in citing
recent studies.

The FDA is seeking advice on a wide range of questions on the popular
stents, including whether to update their labels with new warnings,
identify patients for whom they aren't appropriate and perhaps change
federal recommendations on how long people should take blood thinners
like Plavix and aspirin following stent surgery.

The agency also wants advice on what research is needed, both on the
drug-coated stents already on the market and others it has yet to
consider approving.

The miniature lattice-shaped tubes are coated with drugs that slowly
dissolve _ or elute _ into the bloodstream to prevent regrowth of
tissue that can clog arteries anew. Boston Scientific Corp. and Johnson
& Johnson are the only two companies approved to sell the drug-coated
versions.

Labels on those stents recommend patients take baby aspirin and Plavix
for either three or six months, depending on the manufacturer,
following surgery. Many patients remain on the drugs longer.

Multiple studies have suggested the risk of blood clots, heart attack
and death rises in patients who stop taking those drugs early. The FDA
staff said it is unknown how long patients should remain on the drugs
to prevent life-threatening clots from forming.

In the new study, researchers found that patients who quit taking
Plavix even six or 12 months after receiving a drug-coated stent faced
more than twice the risk of premature heart attack or death than did
those patients who remained on the pricey drug. Plavix, also known as
clopidogrel, can cost $1,400 a year.

"The bottom line from our paper, for doctors and patients, is these
results tilt the balance to the fact you should stay on clopidogrel if
you have a drug-eluting stent indefinitely until further data tell us
how long you should be on it," said Dr. Robert Califf, a Duke
University cardiologist.

Details appeared Tuesday on the Web site of the Journal of the American
Medical Association.

Califf and his colleagues also recommend a 10,000-patient, three-year
study to determine whether long-term Plavix use is beneficial. One
researcher questioned whether that would be useful, given rapid
advances in stent technology and the time required to complete such a
study.

"You're talking four to five years down the road and all these stents
are going to be obsolete," said Dr. Spencer King, a cardiologist at the
Fuqua Heart Center in Atlanta's Piedmont Hospital and past president of
the American College of Cardiology.

Another suggested enrolling patients could be difficult if not
downright unethical, since researchers would stop giving Plavix to some
patients after a year or two and presumably switch them to placebo or
dummy pills. Others would stay on the real drug for three years.

"I don't know many cardiologists or their patients who would want to be
on the placebo end of that," said Dr. Robert Bonow of Northwestern
University and a past president of the American Heart Association.

Boston Scientific has acknowledged a slight increase in clotting
associated with its drug-coated stent, the Taxus, but said it's seen no
corresponding increase in heart attacks or deaths. Johnson & Johnson
said there's no significant difference in clotting, heart attack or
death rates between its stent, the Cypher, and bare metal versions.
Both companies said use of the drug-coated stents reduces the need for
follow-up surgeries to reopen clogged arteries.

However, multiple studies have suggested the risk of blood clots, heart
attack and death rises in drug-coated stent patients who stop taking
Plavix and aspirin early.

Long-term risks of treatment with Plavix are unknown, the FDA
cautioned. The drug, also known as clopidogrel, can cause major
bleeding.

The FDA said the risk of blood clotting applies to the drug-coated
stents when used as labeled. However, the agency acknowledges that more
than 60 percent of the stents probably are implanted in types of
patients not studied during the trials of the devices that led to their
approval. That off-label use often involves more complex cases; those
patients may well benefit more from the drugs in the coated stents but
also face greater clotting risk, complicating the issue.

Doctors now implant stents in about 650,000 Americans a year. Since the
first drug-coated stents gained FDA approval in 2003, they have gone on
to capture 80 percent of the stent market. Doctors like them because
there is less reclogging of the arteries in patients given drug-eluting
stents.

Another significant question is whether that early benefit is
outweighed by a later increased risk of clotting, heart experts said.
Why that would be the case is unknown, although researchers have
suggested a connection with the rate at which cells in the arteries
grow back to envelop the stents. They're also looking at the polymers
used to bind the drugs.

Meanwhile, Bonow and others suggested drug-eluting stents should be
used more selectively and judiciously. In part that could depend on
assessing the risk that a patient's arteries could clog again after
surgery or how well they could tolerate _ or afford _ long-term use of
Plavix.

About 6 million people worldwide have one or more drug-eluting stents
in their body. Califf estimates only 20 percent to 30 percent of those
patients take Plavix for 12 months or more. That potentially puts tens
of thousands of them at risk of heart attack or death each year, he
said.

___

On the Net:

Journal of the American Medical Association: http://jama.ama-assn.org/

Food and Drug Administration: http://www.fda.gov/

... URA Redneck if you have romantic thoughts when sheep bleat.