Blood Clots Four to Five Times More Likely With Drug Coated Stents Than Older Bare Metal StentsA study published in the December 2006 issue of the American Journal of Medicine, found that blood clotting is four to five times more likely to occur with the newer drug eluting coronary heart stents than with the older bare metal stents. The increased risk of blood clotting (thrombosis) is associated with an increased risk of heart attack and death. The two FDA approved drug eluting stents are Johnson & Johnson’s Cypher Stent (emited sirolimus) and Boston Scientific’s Taxus Stent (emits paclitaxel).
As a result of this study, the researchers have recommended that patients with Johnson & Johnson Cypher stents should take anti-clotting drugs for two to three months following implantation, and those patients with the Boston Scientific Taxus stents should take anti-clotting drugs for six months or more following implantation. Anti-clotting or anti-platelet drugs such as Plavix (clopidogrel) and aspirin are often prescribed after the stent procedure.
Drug Coated Stents and Heart Attacks
A second study published in 2007 found that drug coated stents posed a particular risk to patients with a history of heart attacks. The Drug Coated Stents study, conducted by researchers at the Bichat-Claude Bernard Hospital in Paris, France, analyzed a patient database from 94 hospitals in 14 countries. The patients involved in this research had heart attacks that had resulted from a blood clot that completely blocked blood flow to the heart – the most damaging type of heart attack. Patients with the drug coated stents were five times more likely to die than patients who received the bare metal stents. The researchers hypothesize that heart attack victims might have problems with the drug coated stents because blood vessels narrow following such a cardiac episode. This can lead to a gap around the stent – an ideal place for a blood clot to form.
Drug coated stents were developed to address the problem of restenosis, or reclosure of an artery following angioplasty. In angioplasty, a balloon is inserted through an incision in the groin or arm and moved to the place of the blockage. It is inflated in order to expand the opening and allow for more regular blood flow. Following this, a stent is then inserted through the vessel to the place cleared by the balloon. The stent holds the artery open, acting as a scaffolding supporting the vessel walls. With the older bare metal stents, the artery would heal around the device, and the resulting scar tissue would sometimes reblock the artery (restenosis).
Drug coated stents were then developed. The drugs that are emited from the polymer are intended to suppress the formation of scars and prevent the arteries from closing again. Because the drugs prevent the artery lining from healing around the device, the device creates a location for blood clots to form. Heart attacks are often the result of blood clots in stent patients. Other companies, Abbott Laboratories and Medtronic, are developing stents designed to gain a piece of the $6 billion annual stent market. Stents which dissolve are also under development.
Need Legal Help Regarding Drug Coated Stents?
If you or a loved one suffered blood clotting (thrombosis) after having a drug-eluting stent implanted following angioplasty surgery, you are encouraged to contact Parker & Waichman, LLP for a FREE case evaluation by a qualified defective medical device attorney. Call 1-800-YOURLAWYER (1-800-968-7529) or fill out our form at the right.