Recent Studies Increase Concern Among
Researchers About Potential
for Dangerous Blood Clots in Individuals with Drug-Eluting Stents What Does this Mean For Patients?
The results of several studies tracking the health
of patients who received drug-eluting stents were released in September
at a major international
meeting of cardiologists -- The World Congress of Cardiology in Barcelona,
Spain. These studies suggested higher levels of "late stent thrombosis," or
blood clots, and other problems than had previously been reported with
drug-eluting stents. (For the full story, see our article: “Problems
Resurface with Drug-Eluting Stents”)
Research is continuing to determine whether drug-eluting
stents lead to complications in a small number of patients a year or
more after implantation.
Researchers are re-examining patient selection guidelines to determine
which patients may fare better with older bare metal stents. Others are
investigating hypersensitivity reactions in some patients that may lead
to inflammation and contribute to blood clots and other serious complications.
And, researchers are developing new types of "bioabsorbable" stents
that may reduce or eliminate the risk of late stent thrombosis.
Meanwhile, should you as a patient be concerned?
Angioplasty.Org has monitored
these issues for some time,
and here is what we recommend:
If You Have Received a Drug-Eluting Stent
First of all, don't panic. Adverse events,
like late stent thrombosis, are very rare. Angioplasty and stents have
been extremely
successful in
opening clogged arteries and improving the lives of patients. Over
six million drug-eluting stents have been implanted and it is only
over very
widespread use that these rare complications emerge: a variety of
studies worldwide have reported complications anywhere from 0-3%;
most researchers are currently saying that the chance of late stent
thrombosis is around 0.6% -- less than 1 in 100.
It is crucial that you continue taking your prescribed
anti-clotting (antiplatelet) medications. Most cardiologists have
been recommending
clopidogrel (Plavix) or ticlopidine (Ticlid) for twelve months and
aspirin for life.
These blood-thinning medications are critical in preventing blood-clots,
a known risk that accompanies stent implantation. If you require surgery
or medical procedures, talk to your interventional cardiologist
before discontinuing any antiplatelet therapy.
Talk to your cardiologist about the study results
presented in Barcelona. Discuss the possibility of continuing Plavix
regimens
beyond your original
prescription, until more data have been accumulated regarding thrombosis
risk after the first year. Some physicians are even recommending Plavix,
along with aspirin, for life. Antiplatelet medications can have side
effects, so long term use is not for everyone.
If Your Doctor Has Recommended Angioplasty and Drug-Eluting Stents
Discuss these new studies and concerns about
late-stent thrombosis with your cardiologist.
Ask about options: new patients should ask doctors
to explain the pros and cons when they recommend a drug-eluting stent
(some studies suggest that in arteries greater than 3mm, drug-eluting
stents may offer little advantage over less thrombogenic bare metal
stents).
Drug-eluting
stents reduce the likelihood of restenosis, or reclosure of the
artery, a problem that occurs in 15-20% of patients with bare
metal stents. (In those patients a second angioplasty is needed
to re-open an
artery that closed.) Lowering the chance of restenosis is
important, especially for diabetics or people with small
arteries. But drug-eluting stents also
require longer use of anti-clotting medications, which are expensive
and can have side effects. Every individual is different; explore
the options for your particular case.
Ask your doctor to thoroughly review your drug-sensitivity
history and consider whether you might have any allergy to metals.
Discuss
the issue of Plavix sensitivity. If you have some history and are
concerned,
you might suggest a Plavix trial before you get a stent to determine
if you have problems with required medications.
If you receive a drug-eluting stent, understand
that you will need to be diligent about taking your anti-clotting
medication. Check
your insurance
to be sure this relatively expensive medication is covered. Also discuss
with your physician any surgery or dental procedures you may be anticipating
in the near future. Blood thinners can cause bleeding problems during
surgery,
but
stopping
antiplatelet therapy even for a short while may lead to increased risk
of clotting.
Angioplasty.Org is urging stent patients
to ask physicians and regulators to support research to develop tests
to determine which patients
might have rare sensitivity reactions either to the required medications
or to drug-eluting stents.
Visit our Discussion Forums to hear what other
patients have to say about Plavix, drug sensitivity and other issues.
Angioplasty.Org is the only site on that net that has been collecting
patient stories about adverse events following drug-eluting stent implantation.
We are an independent site that relies on volunteer participation. If you
have found this site useful, please consider making
a donation so that
we can continue to provide one-of-a-kind medical reporting and patient
support.
posted September 14, 2006 -- updated October 28,
2006
Angioplasty.Org
interviewed a number of leading cardiologists in preparing
these recommendations. Here are some of their comments:
"...until
we have more data, I would recommend ASA [aspirin] and Plavix "indefinitely" -- Dr. Salim Yusuf,
McMaster University,
Hamilton, Ontario
"...we are very careful about selecting patients...
for
someone who's not going to take their Plavix
...
for
any reason, allergies,
GI bleeds...
can't afford
the ration
of Plavix, we're not going to put a drug-eluting stent in." -- Dr. Gary Roubin,
Lenox Hill Heart and Vascular Institute of
New York
"We find that the biggest risk of thrombosis is if
somebody stopped their Plavix. What I always write on my
prescriptions when I send somebody home on Plavix is, "Never
stop unless directed
by a physician." -- Dr. Felix Millhouse,
San Francisco
Heart & Vascular Institute
"We really are counseling the patients -- under no
circumstances allow any other doctor to stop the Plavix without
consulting
the cardiologist." -- Dr. William O'Neill,
University of Miami
"And if you're going to have to take [Plavix] for
a year, maybe they ought to tell the patient that. And by
the
way,
you're
going to have to pay for it for a year.... I think patients
deserve to have all of this information.." -- Dr. Spencer B. King III,
Fuqua Heart Center of Atlanta, former President of American College of Cardiology
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