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Questions and Answers on Coronary Drug-Eluting Stents

Q: What are Stents?

A: Stents are small, lattice-shaped, metal tubes that are inserted permanently into arteries. They are used to hold open arteries that have narrowed due to plaque build-up (atherosclerosis). When artery walls thicken, the pathway for blood narrows. This can slow or block blood flow.

Stents are used frequently to treat blockages in the blood vessels of the heart. Once in place, stents help hold the arteries open so that the heart muscle gets enough blood. As the body accepts the stents, it grows heart vessel tissue over them.

Stents can be made of only metal (bare metal stents) or they can be coated with small amounts of drugs that are released over time to help keep the arteries from being blocked again (drug-eluting stents).

For more information, see FDA Heart Health Online: Stent.

Q: What are the Risks of Stents?

A: FDA considers bare metal and drug-eluting stents to be safe and effective when used according to their instructions, but all stents involve some risk. In rare cases, the stent placement procedure can involve complications such as heart attack, blood clots, bleeding, abnormal heart rhythm or blood vessel injury. In some cases, excessive scar tissue can develop within the stent (restenosis).

Studies have shown that drug-eluting stents show a significant reduction in the need for repeat procedures to treat restenosis.

Q: Do Drug-Eluting Stents have Additional Risks?

A: Recent research suggests that in rare cases patients may develop clots in their drug-eluting stents that may cause an increased risk of heart attack or death. This can happen many months or even years after they received their stents. Medications are given after stenting to reduce the risk of blood clots, but we do not know the optimal duration of treatment.

Q: What is FDA Doing to Understand the Problems with Drug-Eluting Stents?

A. FDA is evaluating all available scientific information that might help it better assess the long term risks and benefits of drug-eluting stents. FDA is also asking outside experts to help evaluate recent research. FDA believes that is important to hear from medical health professionals and the public before making any recommendations about stent use.

FDA is holding a panel meeting on this topic on December 7-8, 2006. For details on this meeting, see Circulatory Systems Device Panel.

Q: If I Have a Drug-Eluting Stent, What Should I Do?

A: FDA believes the vast majority of these devices are safe and help millions of people. In rare cases, a blood clot can form inside the stent, which can lead to heart attack or death. These events usually occur in the first 6 months after receiving a stent, but recent information suggests that they can happen later. At this time, not enough is known about which patients or patient groups are more likely to have clotting problems. FDA is convening a meeting of outside experts to evaluate new information about the clotting problem. This new information, together with ongoing and planned studies, will help FDA make recommendations to improve patient care. FDA will make its recommendations available to the public as soon as possible.

In the meantime, if you have questions about your current heart medications, talk to your cardiologist. If you receive a drug-eluting stent, your doctor will prescribe certain medications (aspirin and Plavix) to prevent the risk of clotting in the stent. It is important that you continue your medications as prescribed. If another physician or health care provider recommends changes in your medications (such as before a colonoscopy or dental procedure), check with your cardiologist first.

Q: What Should I Do if I Need a Stent Now?