Cardiologists Issue Guidelines for Stent Use

Goal is to reduce blood-clot risk in heart patients getting drug-coated devices

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By
HealthDay Reporter

THURSDAY, Jan. 11, 2007 (HealthDay News) -- A leading cardiology association issued a "clinical alert" Thursday to help guide physicians in reducing the risk of blood clots when inserting drug-eluting stents in heart patients.

"We view this as sort of a wake-up call and back-to-basics approach," said Dr. John Hodgson, lead author of the alert, a past president of the Society for Cardiovascular Angiography and Interventions (SCAI), and chief of academic cardiology at St. Joseph's Hospital and Medical Center in Phoenix. "We've all gotten a little bit complacent with drug-eluting stents."

The SCAI issued the alert, which was published online as part of the organization's official journal, Catheterization and Cardiovascular Interventions.

Stents are small, mesh tubes that prop open narrowed arteries. Traditionally, bare metal stents, which perform a purely mechanical function, were used. But these stents carry a risk of reclosing -- or restenosis -- of the artery, which, in turn, requires additional surgery.

Drug-eluting stents were introduced three years ago and have now become dominant tools in the field of cardiovascular surgery. These stents slowly release a medication that prevents the build-up of scar tissue, which can result in reclosing of arteries. But recent evidence suggests that drug-eluting stents carry a risk of producing potentially dangerous blood clots.

In December, a U.S. Food and Drug Administration advisory panel recommended that drug-eluting stents stay on the market but with caveats, including updated labeling and additional research.

An estimated 6 million people worldwide have received drug-eluting stents, 3 million of them in the United States.

"One of the harsh realities is that we find ourselves in a moment in time where we have raced ahead with technology and applied it broadly to many patient types in the absence of good data and probably with good intent," said Dr. Kirk Garratt, clinical director of interventional cardiovascular research at Lenox Hill Hospital in New York City and a member of the board of trustees of SCAI. "But we're probably learning that at least in some of the patients, we need to be circumspect before putting in a drug-eluting stent."

The new alert is directed to interventional cardiologists and gives advice on how to evaluate and reduce the risk of late stent thrombosis -- blood clots after stent placement. Among the recommendations:

  • Before inserting a stent, doctors should make sure that patients meet the accepted criteria as defined by the American College of Cardiology, the American Heart Association and the SCAI. "We need to make sure we're doing everything appropriately, make sure there was a real indication for the stents in the first place," Hodgson said. "Our stent rate is among the highest, if not the highest, in the world. We may be overzealous, so we need to go back and make sure [about] the criteria and indications."
  • Deciding whether a patient receives a drug-eluting stent or a bare metal stent should be made on an individual basis. "We need to very carefully consider the pros and cons of different strategies to make sure we're doing whatever is best for the patient," Hodgson said.
  • Physicians need to be diligent about implantation techniques, Hodgson emphasized.
  • Patients should take dual anti-clotting medication for at least three to six months -- and preferably one year -- after receiving a stent. Patients with a higher-than-average risk for late stent thrombosis should consider taking anti-clotting agents even longer and perhaps at different dosages.
  • Physicians should evaluate each patient individually before discontinuing anti-clotting medication.

Heart specialists pointed out that, despite the problems, the stenting procedure is still relatively safe.

"I don't think the data are as alarming as some have made them out to be," Garratt said. "For the typical patient who's in their 60s, 70s or 80s, for the remaining 20 years of life, we would expect them to have an increased risk of 2 to 3 percent, but that's not very much when you consider the benefits that they're getting."

More information

Visit the American Heart Association for more on stents.

SOURCES: John Hodgson, M.D., chief, academic cardiology and professor, medicine, St. Joseph's Hospital and Medical Center, Phoenix; Kirk Garratt, M.D., clinical director, interventional cardiovascular research, Lenox Hill Hospital, New York City; Jan. 11, 2006, Catheterization and Cardiovascular Interventions online

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