Information for Patients
Why are stents in the news lately?
What is a blood clot?
How would I know if I had a blood clot?
How serious is a blood clot?
How long should I be concerned about the potential risk?
What can I do to reduce my risk?
Should I request a bare-metal stent if I need another stent in the future?
What are the advantages of drug-coated stents?
What actions should I take if I have—or receive—a drug-coated stent?
What if another doctor tells me to stop taking my medications before having a medical procedure?
What is being done to address the issue of blood clots?
What should I do next?
Our Commitment to You
Important Information
Information for Patients
Since 2002, more than 6 million people with coronary artery disease have received a new kind of stent. These “drug-coated”—or “drug-eluting”—stents are tiny metal mesh tubes designed to prop open arteries that may have been partially blocked by plaque. A bare-metal stent props open arteries in the same way. But the newer stents are also coated with a special medication. After these stents are implanted, they slowly release the medication over a period of weeks. One important benefit of drug-coated stents is that the medication helps reduce the chance of new tissue or scar tissue from blocking the same section of artery again. This reblockage—called restenosis—can sometimes be a problem with stents.
Recently doctors and researchers have been actively discussing the merits of drug-coated stents made by a number of stent manufacturers. One topic of focus is the very low chance that a blood clot could develop in a person with a drug-coated stent. At Boston Scientific, we have been carefully studying the safety and effectiveness of our stents since long before they were approved by the Food and Drug Administration (FDA).
We continue to conduct important research related to the safety and effectiveness of our products. In addition, we are committed to sharing information to enable doctors who use our products to make appropriate treatment decisions with their patients. We encourage you to talk with your doctor about your specific situation so that together you may make informed decisions about the treatment of your coronary artery disease.
Why are stents in the news lately?
You may have heard news reports discussing recent study findings about drug-coated stents in general, not just those made by Boston Scientific. The findings showed there is a very small risk of a blood clot—also called a stent thrombosis—developing in some patients who have drug-coated stents after one year. Note that there is also a very small risk of a blood clot developing with bare-metal stents. At four years of follow up, patients with a Boston Scientific drug-coated stent showed no increase in heart attack and the same chance of survival compared to patients with bare-metal stents. Drug-coated stents are both safe and highly effective for patients when used according to the packaging directions.
FACT: More than 6 million people have received a drug-coated stent since 2002.
What is a blood clot?
A blood clot in a patient who has a stent is also called a stent thrombosis. In a tiny percentage of patients with stents, blood cells can become sticky and clump together to form a small mass—or clot. When a blood clot forms, it can block the free flow of blood through an artery.
How would I know if I had a blood clot?
In the rare event that a blood clot develops, you might have one or more of the following symptoms:
- Pain or discomfort in the chest, shoulders, arm, back, and/or jaw
- Nausea
- Lightheadedness
- A cold sweat
- Shortness of breath
- Fainting or collapsing
- Pale skin color
- Unusual fatigue
These may not be the only symptoms of a blood clot. A blood clot can be treated if medical treatment is administered quickly. If you experience any of these symptoms you should immediately get to a hospital emergency room for treatment right away. Be sure to call 911; do not drive yourself.
How serious is a blood clot?
If blood flow is severely blocked in an artery that
supplies blood to the heart muscle—called a coronary artery—a
portion of the heart muscle may be damaged. You may hear this event
referred to as a myocardial infarction or MI, but the common term is
heart attack. A heart attack, if severe, can be fatal. That’s
why it’s so important to act quickly if you have any of the symptoms
listed above.
How long should I be concerned about the potential risk?
Although the greatest risk occurs right after you receive your stent, recent studies have shown that in very rare circumstances a blood clot could form a year or more later.
FACT: Boston Scientific’s drug-coated stents have improved the quality of life for millions of people.
What can I do to reduce my risk?
First, take all of your medications as directed.
Doing so is extremely important, since the medications can help prevent
blood clots from forming. Generally, two anticlotting medications will
be prescribed, usually aspirin and a prescription anticlotting medication
such as Plavix® or Ticlid®. Because they work together, both
medications must be taken according to your doctor’s instructions.
Second, follow all of your doctor’s recommendations about managing your heart disease, including those related to diet, exercise, and not smoking.
Third, know the symptoms that signal a blocked artery or a heart attack. Call 911 immediately if you notice one or more of the symptoms listed above or any other symptom of concern. Remember that blood clots can be treated with prompt medical attention at a hospital.
Should I request a bare-metal stent if I need another stent in the future?
The first step in making decisions on any future procedures or operations is to speak with your doctor. Remember that each person’s situation is different. Your doctor is the person who is best able to evaluate your individual case and evaluate which type of stent is right for you. See the Important Information section below to learn more about the TAXUS Stent and some of the risks associated with this medical device.
What are the advantages of drug-coated stents?
Studies show that drug-coated stents—compared with bare-metal stents—are much better at reducing the chance that an artery will become blocked again. Reblocked arteries and additional procedures to treat them (angioplasty or bypass surgery) may both contribute to major health complications.
FACT: Drug-coated stents are highly effective: twice as many patients who have bare-metal stents require a repeat procedure compared with patients who have drug-coated stents.
What actions should I take if I have—or receive—a drug-coated stent?
One cannot overemphasize the importance of following your doctor’s instructions regarding medications. Do not stop taking your medications as prescribed for any reason without your doctor’s approval—even if you feel fine or don’t think they’re helping. These medications—usually aspirin and Plavix® or Ticlid®—are the best way to help prevent blood clots. It’s also important to follow your doctor’s other instructions as well, particularly regarding a heart-healthy diet, regular exercise, and not smoking. Participating in a cardiac rehabilitation program with other patients can help you learn the most effective ways to manage your heart disease.
What if another doctor tells me to stop taking my medications before having a medical procedure?
Tell your heart doctor (cardiologist) about any other medical or dental procedures you are planning. Your heart doctor is the best person to advise you on your heart medications and will let you know whether you should stop your medications before the procedure. It’s extremely important that you continue taking your medications as directed unless your heart doctor tells you to stop.
What is being done to address the issue of blood clots?
Often new research findings mean that more research is needed, and that’s true in this case too. More research is being performed by various groups throughout the world. These groups include medical device manufacturers, hospitals, university groups, independent doctors, and industry groups. Boston Scientific will continue to conduct our own research to confirm the long-term safety and effectiveness of our stents. We welcome rigorous independent studies that will help the industry understand more about this issue. Only through continued strong research will we ensure that we offer patients and doctors the safest, most effective treatments possible.
What should I do next?
- Talk with your doctor if you have questions about your unique medical condition or treatment plan.
- Continue taking your medications as prescribed by your doctor, even if you feel fine or don’t think they’re helping.
- Learn more by visiting the websites listed.
Our Commitment to You
Boston Scientific is committed to providing important information so that doctors can help patients make decisions about treatment options. We remain confident in the overall safety and effectiveness of our TAXUS stents.
Important Information:
The TAXUS® Express2™ Paclitaxel-Eluting Coronary Stent System is intended to be placed into certain types and sizes of coronary arteries to keep them open. This medical device is not appropriate for use in patients who are known to have an allergy to any components of the device (such as the drug paclitaxel, the SIBS polymer coating or 316L stainless steel) or who would otherwise be judged by a medical professional to not be appropriate candidates for placement of coronary stents (such as patients unwilling or unable to take prescribed antiplatelet medicines). Use of coronary stents carries certain risks, including the potential for serious injuries, side effects and even death. The complete FDA-approved directions for use and patient guide (with specific indications, contraindications, precautions and warnings) can be found on the Internet at www.taxus-stent.com or a copy can be obtained, free of charge, by calling 1-877-TAXUS-411 (1-877-829-8741). Patients should discuss the benefits and risks with their physicians to determine whether the TAXUS® Stent is an appropriate treatment choice. Federal law restricts this product to sale by or on the order of a physician.
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