New Advisory: Will
Stent Patients and
Their Doctors Get the Message?
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January 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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