What is the CYPHER® Stent? |
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The CYPHER® Stent has three parts:
The Stent: a small, expandable, slotted stainless steel tube that is inserted into a coronary artery (one of the blood vessels that supply the heart with oxygen and nutrients). A stent acts as a scaffold that helps hold the artery open in order to improve blood flow to the heart and relieve the symptoms caused by the blockage.
The stent has a closed-cell design, with a repeating pattern that allows the medication to be distributed evenly across the artery wall.
The anti-rejection-type medication (sirolimus): an anti-rejection-type medication that limits the overgrowth of normal tissue as the healing process occurs following coronary stent implantation.
The inactive ingredient: a polymer (soft-plastic) coating on the stent that contains the medication sirolimus, and slowly elutes (releases) the medication into the artery wall around the stent. The coating releases the medication over 90 days to prevent the overgrowth of natural tissue while allowing the artery to heal itself.
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How is the CYPHER® Stent used? |
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The CYPHER® Stent is used to help open coronary arteries in people who have symptoms of a lack of blood flow to the heart (ischemic heart disease), such as blockage of heart arteries or chest pains (angina), due to fatty plaque deposited on the inner lining of blood vessels (atherosclerosis).
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How does the CYPHER® Stent work? |
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The CYPHER® Stent works by restoring blood flow to a blocked artery.
Overgrowth of tissue (restenosis) is believed to be a major factor responsible for renarrowing of the artery after stent placement. The drug coating on the CYPHER® Stent limits this overgrowth of normal tissue, which significantly reduces the chance of re-blockage and the need for another procedure.
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Is it possible to have the stent removed? |
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Coronary stents are permanent implants and cannot be removed.
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How long does the medicine, sirolimus, stay on the stent? |
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The medicine on the CYPHER® Stent is called sirolimus, and is designed to last about 90 days. The amount of sirolimus on the CYPHER® Stent is a very small dose compared to the standard oral dose. The coating on the stent delivers sirolimus directly into the wall of the coronary artery, so very little of it gets circulated throughout your body. After 90 days your body has healed the area around the stent and the medicine on the stent is no longer needed.
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Who should not receive the CYPHER® Stent? |
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- If you cannot take aspirin or blood-thinning medications (also called antiplatelets or anticoagulants).
- If you have an allergy to the drug sirolimus, structurally-related drugs or a certain category of polymers known as polymethacrylates or polyolefin.
- If the physician decides that the blockage will not allow complete inflation of the angioplasty balloon or proper placement of the stent or delivery balloon.
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What other medical issues should I discuss with my doctor? |
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If you know in advance that you will be receiving a CYPHER® Stent, your doctor will ask you to follow certain instructions. For several days before the procedure, you may be asked to take aspirin and other prescribed medications.
Caution. Be sure to let your doctor know:
- If you are taking any other medications
- If you have a history of bleeding problems
- If you have any metal allergies (i.e., 316L stainless steel)
- If you are allergic to the drug Rapamune (sirolimus), its derivatives or a certain category of polymers known as polymethacrylates or polyolefin
- If you are currently taking Rapamune*
- If you are currently or think you may be pregnant
- If you are currently nursing
- If a dental or surgical procedure is scheduled to follow your CYPHER® Stent procedure while on antiplatelet medication
*Note: Sirolimus is also available in tablet and liquid form, known by the name Rapamune. Let your doctor know if you are currently using this drug.
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What are the possible side effects of the CYPHER® Stent? |
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Use of the CYPHER® Stent carries the risks associated with all coronary stent placement, including allergic reaction, irregular heart rhythm, stent thrombosis (blood clot in the stent), death, reactions to antiplatelet or anticoagulant medications or to dyes used during placement, emergency bypass surgery, fever, bleeding at the puncture site, chest pain or angina and stroke. The risk of thrombosis with any stent, uncoated or drug-eluting, remains low. Our two clinical trials following patients over a five-year period indicate a similar overall risk of thrombosis between the CYPHER® Stent and uncoated stents. However, after 1 year, a very small increased risk of stent thrombosis can be seen with the CYPHER® Stent versus uncoated stents that did not reach statistical significance.
Potential adverse events which may be associated with the implantation of a coronary stent include allergic reaction, irregular heart rhythm, death, drug reactions to blood-thinning agents or contrast media, emergency bypass surgery, fever, bleeding at the puncture site, chest pain or angina, and stroke. Potential adverse events related to the drug sirolimus (based on studies of patients who used the drug orally for a prolonged period of time) include infection, tumor formation, fatigue, joint pain and diarrhea.
Exposure to sirolimus and the polymer coating on the CYPHER® Stent is directly related to the number of implanted stents. Use of more than two CYPHER® Stents has not been adequately evaluated. Use of more than two CYPHER® Stents will result in your exposure to a larger amount of sirolimus and polymer coating than experienced in the clinical studies.
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What can I expect after I receive the CYPHER® Stent? |
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You should be able to return to your normal activities, such as work, sports, and sex, soon afterward. But remember to always check with your doctor prior to doing anything that is physically strenuous.
Your doctor will prescribe medicines for you to take once you leave the hospital. You may need to have follow-up blood tests to monitor the effects of the medicine.
Tips about your medication plan:
- It is very important that you take your medicine exactly as prescribed.
- Be sure not to miss any doses.
- Call your doctor if you develop any adverse effects, such as bleeding, upset stomach, or rash. Or, call if you develop new questions.
- You may need to have follow-up blood tests to monitor the effects of your medicines.
Your doctor may prescribe blood-thinning medicines to help blood flow more easily through your body. You will be asked to take a small daily dose of aspirin indefinitely.
In addition, it’s likely your doctor will prescribe antiplatelet medication for a period of time after your stent procedure, usually a minimum of three months, and often longer. It is extremely important to follow your doctor’s instructions exactly.
If you stop taking these medicines earlier than instructed, you increase the chances of having a blood clot, heart attack or even death. Alert your doctor if any surgery or dental work would require you to stop or change your medication routine.
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How long should I take Plavix and aspirin? |
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The most important thing that you can do after your stent procedure is to follow your doctor’s instructions for taking your anti-clotting medication. Typically, this treatment will consist of aspirin and Plavix (clopidogrel). Do not discontinue your medication without talking to your doctor.
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If my artery becomes blocked by scar tissue, how will I know? What are the symptoms? |
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If your artery becomes blocked by scar tissue, you may experience symptoms similar to when you first noticed you had heart disease before your procedure. These symptoms are caused by a lack of blood supply to your heart muscle. They may include chest pain (angina) or shortness of breath, especially during exercise or any physical activity, such as climbing stairs. Your doctor will be able to discuss this with you in more detail.
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Can you tell me more about the dangers of the drug-coated stent? I have been hearing/reading reports that this stent causes blood clots and people die after having one implanted. |
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A blood clot within the stented area, called a stent thrombosis, can occur at any time after a stent has been implanted. This is true for both drug-coated stents and bare-metal stents (uncoated). Stent thrombosis is a rare event, but when it occurs, it can close off the artery, blocking the flow of blood to the heart. This can potentially lead to a heart attack or even death. The warning signs for stent thrombosis include chest discomfort, discomfort in other areas of the upper body, shortness of breath, cold sweat, nausea, light-headedness and/or fainting. If you experience one or more of these signs, call 911 immediately and get to a hospital right away.
Please see Important Patient Safety Information. for further detail.
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Is it safe to have an MRI? What is the stent made of? |
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The CYPHER® Stent is made of stainless steel, and can be scanned safely by an MRI immediately after implantation, under certain conditions. Please check with your doctor before having an MRI.
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Is it safe to have a mammogram/CT scan/X-ray/nuclear stress test with a CYPHER® Stent? |
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Yes. Mammography, CT scanning, X-rays and nuclear stress tests can be performed on people who have the CYPHER® Stent.
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Is it safe to go through the metal detector at the airport or security checkpoints in stores? |
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Yes. Going through a metal detector at the airport, or a security checkpoint in a store will not harm your stent. And it’s unlikely that the stent will trigger the alarm. If it does, present your card to the official.
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How can I get a replacement ID card? Why should I carry it? |
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Your card lets medical personnel know that you have coronary heart disease, tells them the location of your stent in your heart, and may alert them to the fact that you are likely to be taking anti-clotting medication. It is important to carry your card in case you need a medical procedure, have a new health care provider, or go to an emergency department.
If you need a replacement card, call CYPHER® Stent Medical Information Center (1-800-781-0282) to request one. Please note that Cordis does not have patient records, so the card you receive will be blank. Your doctor should be able to provide the information to help you fill out the card.
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How can I get more information about the CYPHER® Stent? |
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For questions regarding your CYPHER® Stent or procedure, please contact your treating physician or Cordis Medical information Center at 1-800-781-0282.
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