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 drug-eluting stents. The document follows hearings held by the FDA’s Circulatory Systems Device Panel. SCAI’s clinical alert focuses on 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.
SCAI’s clinical alert, published online in 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.
“Practicing physicians and their patients are naturally concerned by the recent finding of a very small, but important risk of very late stent thrombosis. Since SCAI’s membership includes the vast majority of practicing interventional cardiologists, we felt it was critical to give some practical advice and guidance in an attempt to ensure optimal outcomes for our patients with coronary artery disease. Coronary artery disease is still the number one cause of death in the Western world, and anything we can do to maximize therapy while minimizing risk is welcome.” said John McB. Hodgson, M.D., FSCAI, the lead author of the clinical alert, a Past President of SCAI, and Chief of Academic Cardiology at St. Joseph’s Hospital and Medical Center in Phoenix, AZ.
Drug-eluting stents are mesh tubes that prop open narrowed arteries in the heart while slowly releasing a medication that prevents the build-up of scar tissue inside the stent. These tiny devices have been very successful in preventing renarrowing, or restenosis, of the coronary arteries, reducing the rate of this complication by 40?60 percent compared to their bare metal counterparts. However, several recent analyses that tracked patient outcomes for four to five years after stent placement showed that blood clots were slightly more likely to form inside a drug-eluting stent than inside a bare metal stent. It is not yet clear how large the difference in risk is, but available data suggest that in the types of lesions treated in the original controlled trials it is about 0.2% excess (compared to bare metal stents) per year after year one. When this occurs, the patient may suffer a heart attack or even die.
“Given this new information, treatment decisions hinge on assessing the balance between the risk of restenosis and risk of late stent thrombosis,” Dr. Hodgson said. “It is important for the clinician to consider the risk?benefit ratio for each individual patient. Interventionalists are encouraged to involve patients, whenever possible, in these discussions.”