Late Stent Thrombosis
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Recent Studies Increase Concern Among Researchers About Potential
for Dangerous Blood Clots in Individuals with Drug-Eluting Stents

What Does this Mean For Patients?

The results of several studies tracking the health of patients who received drug-eluting stents were released in September at a major international meeting of cardiologists -- The World Congress of Cardiology in Barcelona, Spain. These studies suggested higher levels of "late stent thrombosis," or blood clots, and other problems than had previously been reported with drug-eluting stents. (For the full story, see our article: “Problems Resurface with Drug-Eluting Stents”)

Research is continuing to determine whether drug-eluting stents lead to complications in a small number of patients a year or more after implantation. Researchers are re-examining patient selection guidelines to determine which patients may fare better with older bare metal stents. Others are investigating hypersensitivity reactions in some patients that may lead to inflammation and contribute to blood clots and other serious complications. And, researchers are developing new types of "bioabsorbable" stents that may reduce or eliminate the risk of late stent thrombosis.

Meanwhile, should you as a patient be concerned?

Angioplasty.Org has monitored these issues for some time,
and here is what we recommend:

If You Have Received a Drug-Eluting Stent

  1. First of all, don't panic. Adverse events, like late stent thrombosis, are very rare. Angioplasty and stents have been extremely successful in opening clogged arteries and improving the lives of patients. Over six million drug-eluting stents have been implanted and it is only over very widespread use that these rare complications emerge: a variety of studies worldwide have reported complications anywhere from 0-3%; most researchers are currently saying that the chance of late stent thrombosis is around 0.6% -- less than 1 in 100.

  2. It is crucial that you continue taking your prescribed anti-clotting (antiplatelet) medications. Most cardiologists have been recommending clopidogrel (Plavix) or ticlopidine (Ticlid) for twelve months and aspirin for life. These blood-thinning medications are critical in preventing blood-clots, a known risk that accompanies stent implantation. If you require surgery or medical procedures, talk to your interventional cardiologist before discontinuing any antiplatelet therapy.

  3. Talk to your cardiologist about the study results presented in Barcelona. Discuss the possibility of continuing Plavix regimens beyond your original prescription, until more data have been accumulated regarding thrombosis risk after the first year. Some physicians are even recommending Plavix, along with aspirin, for life. Antiplatelet medications can have side effects, so long term use is not for everyone.

If Your Doctor Has Recommended Angioplasty and Drug-Eluting Stents

  1. Discuss these new studies and concerns about late-stent thrombosis with your cardiologist.

  2. Ask about options: new patients should ask doctors to explain the pros and cons when they recommend 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 reduce the likelihood of restenosis, or reclosure of the artery, a problem that occurs in 15-20% of patients with bare metal stents. (In those patients a second angioplasty is needed to re-open an artery that closed.) Lowering the chance of restenosis is important, especially for diabetics or people with small arteries. But drug-eluting stents also require longer use of anti-clotting medications, which are expensive and can have side effects. Every individual is different; explore the options for your particular case.

  3. Ask your doctor to thoroughly review your drug-sensitivity history and consider whether you might have any allergy to metals. Discuss the issue of Plavix sensitivity. If you have some history and are concerned, you might suggest a Plavix trial before you get a stent to determine if you have problems with required medications.

  4. If you receive a drug-eluting stent, understand that you will need to be diligent about taking your anti-clotting medication. Check your insurance to be sure this relatively expensive medication is covered. Also discuss with your physician any surgery or dental procedures you may be anticipating in the near future. Blood thinners can cause bleeding problems during surgery, but stopping antiplatelet therapy even for a short while may lead to increased risk of clotting.

Angioplasty.Org is urging stent patients to ask physicians and regulators to support research to develop tests to determine which patients might have rare sensitivity reactions either to the required medications or to drug-eluting stents.

Visit our Discussion Forums to hear what other patients have to say about Plavix, drug sensitivity and other issues.

Angioplasty.Org is the only site on that net that has been collecting patient stories about adverse events following drug-eluting stent implantation. We are an independent site that relies on volunteer participation. If you have found this site useful, please consider making a donation so that we can continue to provide one-of-a-kind medical reporting and patient support.

posted September 14, 2006 -- updated October 28, 2006

Angioplasty.Org interviewed a number of leading cardiologists in preparing these recommendations. Here are some of their comments:

"...until we have more data, I would recommend ASA [aspirin] and Plavix "indefinitely"
-- Dr. Salim Yusuf,
McMaster University,
Hamilton, Ontario

"...we are very careful about selecting patients... for someone who's not going to take their Plavix ... for any reason, allergies, GI bleeds... can't afford the ration of Plavix, we're not going to put a drug-eluting stent in."
-- Dr. Gary Roubin,
Lenox Hill Heart and Vascular Institute of
New York

"We find that the biggest risk of thrombosis is if somebody stopped their Plavix. What I always write on my prescriptions when I send somebody home on Plavix is, "Never stop unless directed by a physician."
-- Dr. Felix Millhouse,
San Francisco Heart & Vascular Institute

"We really are counseling the patients -- under no circumstances allow any other doctor to stop the Plavix without consulting the cardiologist."
-- Dr. William O'Neill,
University of Miami

"And if you're going to have to take [Plavix] for a year, maybe they ought to tell the patient that. And by the way, you're going to have to pay for it for a year.... I think patients deserve to have all of this information.."
-- Dr. Spencer B. King III,
Fuqua Heart Center of Atlanta, former President of American College of Cardiology


related stories:

• Problems Resurface with Drug-Eluting Stents

• Boston Scientific Confirms Long-Term Clotting Risk of Drug-Eluting Stents

• Report States FDA Drug Safety System is Broken

• BASKET-LATE Study Shows Higher Rate of Cardiac Death and
Heart Attack for Drug-Eluting Stents vs. Bare Metal Stents

• "What's a Patient To Do?": Getting answers to questions about product recalls and device safety

• Plavix and Aspirin: Discussion Forum

• Plavix and Surgery: Discussion Forum



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