News | January 10, 2007

SCAI Issues DES Clinical Alert

Jan. 11, 2007 — The Society for Cardiovascular Angiography and Interventions (SCAI) today released a clinical alert advising physicians on practical steps for reducing the risk of a rare but serious complication associated with the use of drug-eluting stents. The document follows hearings held by the FDA’s Circulatory Systems Device Panel regarding the use of these devices.

The panel supported the continued use of these devices but also suggested more research to determine whether the devices contribute to an increased likelihood of heart attack and death in complex heart disease patients who receive these stents (see http://www.fda.gov/cdrh/news/010407.html).

SCAI’s clinical alert, published online as part of SCAI’s official journal, Catheterization and Cardiovascular Interventions, focuses on the importance of careful patient selection, meticulous stent implantation, and consistent use of medications to prevent the delayed formation of blood clots that can block blood flow to the heart, a condition known as late stent thrombosis.

This clinical alert has been designed to provide interventional cardiologists with practical advice on how to evaluate and minimize the risk of late stent thrombosis. Its recommendations include the following:

1. Prior to any stent implantation, patients should meet accepted criteria for coronary intervention as described in guidelines jointly published by the ACC, AHA, and SCAI.

2. The decision to treat a patient with a drug-eluting stent—rather than a bare metal stent or bypass surgery—must be made on an individual patient basis, considering the relative risks and benefits of each therapy. This determination will vary according to each patient’s medical history, coexisting illnesses, and lesion characteristics.

3. Patients must be carefully evaluated for their ability to adhere to long-term therapy with dual anti-clotting medications.

4. Careful attention must be paid to stent implantation technique, including the use of intravascular ultrasound, screening for arterial calcification, and pretreatment of complex lesions in some cases.

5. Patients should take dual anti-clotting medication for at least three to six months, preferably for 12 months unless there is a high risk for bleeding. In patients with a higher-than-average risk for late stent thrombosis—for example, those with diabetes—physicians should consider not only continuing dual anti-clotting medication for longer than 12 months, but also testing responsiveness to these medications and adjusting dosages as needed.

6. Discontinuation of dual anti-clotting medication requires careful consideration and must be individualized for each patient.

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