Drug eluting stent advice offered by SCAI

By Austin Kirk
Posted January 14, 2007

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A clinical alert was issued by the Society for Cardiovascular Angiography and Intervention (SCAI) to provide drug eluting stent recommendations and advice to physicians.  The alert is intended to help reduce the risk of medicated stent blood clots and heart attacks, which can occur months or even years after the stents are implanted.

The SCAI’s membership includes nearly all of the specialists who implant cardiac stents, known as interventional cardiologists.  Over the past several months concerns have grown among the medical community and patients regarding stent dangers, which could lead to serious and potentially fatal injuries for patients who receive the devices.  Given the questions surrounding stent problems, the SCAI felt that it was important to provide practical drug eluting stent advice and guidance to the medical community.

>>INFORMATION: Drug eluting stent problems

Since drug coated stents were first introduced in 2003, they have grown to dominate the stent market, accounting for nearly 90% of all stents implanted.  Stents are small wire mesh devices placed inside of previously blocked arteries to keep them open.  Drug eluting stents were designed to prevent the build up of scar tissue inside the artery, which helps reduce the rate of restenosis, or narrowing of the artery which can lead to another blockage.  However, an unintended side effect which the manufacturers failed to warn about is the increased risk of late stent thrombosis, or the formation of blood clots which can lead to heart attacks and death.  Many have questioned whether the dangers of drug coated stents outweigh the benefits provided for many patients.

Drug eluting stent lawsuits are being investigated and reviewed for heart patients nationwide who have suffered blood clots, reclogging of the artery, heart attack or death.  The manufacturers failed to provide patients and physicians with the necessary information to make an informed decision about the balance between the risks of restenosis and the risk of late stent thrombosis, or blood clots.

The SCAI (Society for Cardiovascular Angiography and Intervention) alert stresses the importance of the doctor and patient considering the risk-benefit ratio for each individual before the decision is made to implant a drug coated stent.  Previously, researchers have indicated that thousands of serious injuries and deaths have been caused by medicated stent side effects.  Some of the drug eluting stent advice and recommendations offered to reduce the risk of injury include:

• Before a drug eluting stent is implanted, the patient should meet the accepted criteria for the devices.  (See recent post on 11/20/06: Medicated stent overuse leads to increased risk)  If a patient is not within the accepted criteria for the medicated stents, they are being exposed to the risk of stent problems when their particular condition may not require that procedure.
• An individual analysis must be considered for each patient to determine whether it is best to treat the patient with drug eluting stents, bare metal stents or bypass surgery.  Relative risks and benefits of each therapy should be evaluated according to the patient’s medical history and current health.
• Careful consideration should be given to a patient’s ability to adhere to long term therapy on an anti-clotting medication.  A patient’s failure to take the medication could dramatically increase the risk of serious and potentially fatal injuries as a side effect of medicated stents.  Therefore, unless a patient can reasonably be relied upon to take the medication consistently as directed, they should not be considered a candidate for a drug eluting stent.
• Although the makers of the Taxus paclitaxel eluting stent and Cypher sirolimus eluding stent only recommend 3 to 6 months of anti-clotting medications, the FDA and SCAI have indicated that it is preferable for patients to continue on the drugs 12 months or longer, depending on their risk for late stent thrombosis.  Currently it is unclear exactly how long blood thinners should be taken, as many experts have expressed concern that Plavix side effects could lead to other injuries, including ulcers, internal bleeding, heart attacks and strokes.

DRUG ELUTING STENT ADVICE AND LAWSUITS

If you, a friend or family member have received a drug eluting stent and suffered a reclogging of the artery, blood clots, heart attack or death, you may qualify for a stent lawsuit.  To determine if you may be entitled to compensation, request a free claim evaluation.