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Home » Stent News » October 18, 2006

Patients Worried About Safety
of Heart Stents Turn To The Web

New Data Suggest Increased Blood Clot Risk
Angioplasty.Org Posts Patient Advisory

October 18, 2006, Sag Harbor, NY -- Angioplasty.Org, an authoritative website for heart patients and physicians, has seen a surge in readership following news reports of possible blood clot risk with drug-eluting stents. The site, which receives 70,000 monthly visits, is advising patients with stents to talk to their cardiologist about anti-clotting medications.

Studies presented in September at the World College of Cardiology meeting in Barcelona, Spain created a groundswell of concern about rare but potentially fatal blood clots (late stent thrombosis) in heart patients who have received drug-eluting stents to open clogged arteries, sometimes occurring two years after the devices were placed. Six million stents have been implanted worldwide.

Dr. Gary Roubin of New York’s Lenox Hill Heart and Vascular Center told Angioplasty.Org: "We've had many questions from concerned stent patients since Barcelona." Dr. William O’Neill of the University of Miami has gotten calls from “people who already have [drug-eluting stents] because there's a perception that they're dangerous.”

The largest annual meeting of interventional cardiologists, the TCT (Transcatheter Cardiovascular Therapeutics), is convening in Washington DC next week and has added a special session for physicians titled "Stent Thrombosis Hot Line" featuring a panel of researchers, device manufacturers and representatives of the FDA to address what it calls the "firestorm" around this issue.

"Meanwhile heart patients are asking, what does this mean for me?" says Angioplasty.Org editor Burt Cohen. Clearing arteries with balloon angioplasty, then placing a drug-coated, scaffold-like metal stent to keep the artery open, is the primary intervention for heart patients, more common than bypass surgery; recipients include Dick Cheney, Gerald Ford, Jerry Lewis and San Diego Padres pitcher Doug Brocail. So even rare complications are worrisome.

It’s known that all stents carry a risk of potentially fatal thrombosis (blood clots) and to prevent clotting, cardiologists always prescribe antiplatelet medications, clopidogrel (Plavix) or ticlopidine (Ticlid) plus aspirin for at least three to six months after drug-eluting stent implantation.

But the studies presented in Barcelona reveal that an increased potential for blood clot problems may continue in some drug-eluting stent patients longer than previously understood. Many cardiologists are recommending Plavix for a year or more; some for life.

Dr. Salim Yusuf , Director of the Population Health Research Institute at McMaster University, Ontario, told Angioplasty.Org, "at present, until we have more data, I would recommend aspirin and Plavix ’indefinitely’”.

Angioplasty.Org has surveyed leading cardiologists and posted recommendations for patients:

1) Maintain perspective: late stent thrombosis is not common. Current data suggest less than 1 in 100 chance of a blood clot.

2) Talk to your cardiologist about antiplatelet medication: if you have a drug-eluting stent, discuss the possibility of continuing drugs such as Plavix beyond the initial 6-12 months, until more data have been accumulated. These medications can have side effects; so long term use is not for everyone.

3) Ask about options: new patients should ask doctors to explain the pros and cons when recommending 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 are less likely to close up again than uncoated stents, especially important for diabetics and individuals with small arteries. Every case is different; explore your treatment alternatives.

4) Commit to required medications: understand that if you receive a drug-eluting stent, you need to be diligent about taking antiplatelet drugs, serious and expensive medicines.

Cohen also cautions: "Scores of people on Angioplasty.Org's forums report confusion about antiplatelet regimens. Physicians are sometimes unfamiliar with side effects, and there is disagreement as to when it is safe to discontinue these drugs. Undergoing surgery while on anti-clotting medication is a problem because of the potential for excessive bleeding. So some stent patients have been advised by non-cardiac doctors to go off the antiplatelet drugs to get minor surgery or dental treatment, not realizing that this could lead to a life-threatening blood clot."

There are also hundreds of postings on Angioplasty.Org forums from patients, suffering from hypersensitivity reactions to Plavix or possibly the drug coating on the stent, whose physicians had no explanation for why they were experiencing severe pain, rashes, fevers and other debilitating symptoms.

"No one knows how many people may be prematurely discontinuing antiplatelet therapy, or having rare adverse reactions to required medications or to the stents themselves, all of which may contribute to increased thrombosis rates," says Deborah Shaw, Education Director of Angioplasty.Org. "We're lobbying for better patient education and urging regulators to listen to heart patients who have turned to the web to report problems after getting a stent."

For more information see: "Patient Alert: Late Stent Thrombosis".

Angioplasty.Org, founded in 1997, is an award-winning, highly regarded independent health website used by both health care professionals and patients. The site is recommended by the Department of Health and Human Services and over 800 other referrers, receives 70,000 monthly visits and has reached 4 million people.

Source: Angioplasty.Org

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