Drug eluting stents (also called medicated or drug-coated stents) were invented in response to a common side effect of balloon angioplasty surgery in which the coronary artery became weak and prone to collapse. Stents are a metallic metal “scaffold” or tube that is inserted into the coronary artery in order to prevent collapse. Further developments in stent technology led to drug-coating in which the stent was coated with a pharmacological agent designed to prevent re-blocking (restenosis) through the delivery of time-released drugs into the bloodstream.
Drug eluting stent therapy is accompanied by antiplatelet drugs designed to prevent clotting of the blood within the arteries for at least six months. Common drugs include Ticlid and Plavix, which help to ensure that restenosis does not occur during the time in which the heart’s cells are growing over the stent and allowing it to “grow” into the anatomy of the coronary artery.
The first stents were used in France in 1986, and the first FDA approval for a metal stent occurred in 1994. Drug eluting stents were first introduced in the 1990s and have since grown into a multi-billion dollar business with over six million prescriptions in America and over $5 billion in revenues per year. American manufacturers include Medtronic, Boston Pharmaceuticals and Cordis, and the drug is also manufactured and marketed in Europe.
Despite their growing popularity, drug-eluting stents have been linked with severe side effects including allergic reactions, increased risk for cardiac-related deaths and heart attacks, and thromobosis (blood clotting). The FDA warned United States patients about the Cordis CYPHER stent in 2003 after use of the CYPHER stent led to deaths in some patients due to sub-acute thrombosis, in which blood cells gather and clot around the stent, preventing the passage of blood through the artery.
In addition, a 2006 study conducted in Switzerland found that patients with drug eluting stents are up to 40 percent more likely to die of a cardiac event, or experience a heart attack after insertion of a DES device.
In addition, increased incidence of non-cardiac conditions such as lung disease, cancer and stroke were found in some stent patients. Stent thrombosis, a condition in which blood clots in the artery and prevents blood flow, is among the most dangerous side effects of DES treatment. The risk also exists with non-medicated metal stents, but a disturbing trend has appeared in coated stents in which patients experience a linear and cumulative rate of thrombosis over time.
The release of medication from the stent can lead to delayed healing and actually increase the likelihood of thrombosis at the stent site. In fact, in June 2006, Boston Scientific itself admitted that its own studies showed a higher increase in late stent thrombosis with its medicated stent product, implying that all drug-eluting stents might have this effect (a claim which was vigorously denied by its competitor companies).
Another drug eluting stent side effect is dependence on antiplatelet drugs over the long-term. Since patients are usually put on Plavix and similar antithrombosis drugs after stent insertion, they are subject to the side effects of those drugs, which include a myriad of symptoms such as gastrointestinal bleeding, strokes, rashes, chest pain, flu-like symptoms, allergic reactions, and inability to have surgery in life-threatening conditions due to the drugs’ blood-thinning and anti-clotting effects. This is in addition to the cost of long-term Plavix use: while the minimum antiplatelet drug therapy averages around six months, some patients are prescribed Plavix for life.
If You’ve Experienced Drug Eluting Stent Side Effects
If you have experienced side effects due to medicated stent insertion, seek medical attention immediately.
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