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

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, 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.