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Jan 29, 2007 --
Six of the major physician organizations
in the United States recently published an unprecedented joint "Science
Advisory",
warning patients with drug-eluting stents to stay on their dual antiplatelet
therapy
(aspirin and Plavix or Ticlid) for a least a year. The message carries
significant clinical weight because of the prestige of the organizations
involved:
the American Heart Association, American College of Cardiology,
Society for
Cardiovascular Angiography and Interventions, American College
of Surgeons, American Dental Association and American College of
Physicians**.
Burt Cohen, patient advocate and
Editor-in-Chief of Angioplasty.Org, applauds the
groups
for publicizing
these issues. However,
echoing his
testimony to the FDA Stent Safety
Panel in December, he adds:
"It's admirable and important
for these societies to band together and put out this Advisory.
But there's a disconnect between what these advisories recommend
and what patients experience, as evidenced by the hundreds
of postings from confused patients on our Patient
Forums.
The very same week that the
advisory was published, a dentist told one of our Forum patients
to stop taking her
Plavix -- yet the American Dental Association already had published their
own cautionary study months before, concluding that stopping
Plavix for most dental procedures was unnecessary and potentially
harmful to the patient.
So there's
need for a real and continuing
education initiative. But no one has stepped up to the plate
to fund this -- and there's a reason: because of an FDA rule,
the drug companies who make the antiplatelet medications can't,
and the device manufacturers who make the stents have not wanted
to call attention to this problem. It's a Catch-22."
Cohen points out that cardiologists
have been giving their DES patients long-term Plavix
prescriptions for some time now. A poll done in 2005 showed that
75% of physicians
were already prescribing
Plavix for a year or more. And the danger of early
cessation is not news to the medical profession. A number of
studies from
Milan to Missouri have
shown an increased heart attack and death rate in patients who
prematurely stopped. But Cohen adds, "Prescribing long-term
antiplatelet therapy is one thing; but improving patient-selection
and educational
support so that patients comply is another."
The recent Joint
"Science Advisory" refers to a June
2006 study, authored by John Spertus, MD of the Mid-America
Heart Institute, that 1 in 7 heart attack patients stop taking
their antiplatelet medications within 30 days and that the death
rate in those patients was ten times higher.
Commenting on his study back in June,
Dr. Spertus told Angioplasty.Org:
"There
have been no studies to date that really examined how many patients
getting these new devices are stopping their medicines
early. I think doctors
didn't have much appreciation for how often this happened. I think we
need to continue to educate patients...and I think we need
to be more selective when
deploying drug-eluting stents as cardiologists. There
are patients who simply cannot afford the medication and, if
you
know that
up front, then a bare-metal stent might really be the
proper choice
for those patients."
Chairperson
of the advisory committee, Dr. Cindy Grines of William Beaumont
Hospital
in Royal
Oaks, Michigan,
agrees. As quoted in theheart.org, Dr. Grines stated, "Obviously,
we have not been doing a good job of getting patients to continue
medicines." She added that the purpose of the joint statement
was to get the word out not just to cardiologists, but patients
and other non-cardiac physicians.
The Joint Advisory Committee recommendations
for drug-eluting stent patients echoes a Patient
Advisory, posted
by Angioplasty.Org in September 2006. They are summarized below:
- Cardiologists and patients should
discuss the importance of a year of antiplatelet therapy
BEFORE a drug-eluting stent is implanted;
- In patients who are
likely to be non-compliant, "strong consideration
should be given to avoiding a DES";
- For patients who are likely to need surgery
in the next 12 months, consideration should be given to use
of a bare metal
stent, or balloon only, with stent if needed;
- Healthcare professionals should make a greater
effort to educate patients on the importance
of continuing
antiplatelet medications prior to discharge;
- Patients also should be instructed
to contact their interventional cardiologist before stopping
antiplatelet
therapy, even if stopping is instructed by another healthcare
professional;
- Healthcare providers (surgeons, dentists,
etc.) need to be made aware of the dangers of asking stent
patients to stop
antiplatelet therapy and should communicate directly with the
patient's prescribing cardiologist;
- Elective surgeries where there is a significant
risk of bleeding should be postponed for 12 months after the
stent implantation;
- If an unexpected surgery must be done that
requires cessation of therapy, aspirin should be continued
if possible and full
antiplatelet therapy should be resumed as soon as possible
after the surgery;
- The healthcare industry, insurers, the U.S.
Congress and the pharmaceutical industry should ensure that
the cost of
these drugs do not cause patients to stop taking them prematurely,
thus causing catastrophic complications.
** The American College of Physicians
is billed as having been "represented" in the Advisory,
but has not formally endorsed it -- their approval process
had not yet been completed, and the Committee felt the urgency
to publish. |
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