Due to the discovery of all of these increased risks, experts are now predicting that patients who received the drug eluding stents will be required to take the expensive blood-thinning drug Plavix for life.
In a few short years, these new stents have become one of the best selling devices in medical history. In 2005, about 1.5 million patients were implanted with drug-eluting stents in the US alone, with the market dominated by the Taxus stent from Boston Scientific, and the Cypher from Cordis, a Johnson & Johnson company. Cypher received FDA approval in 2003, and Taxus was approved a year later.
A market analysis in the January/February 2006, issue of Medical Device Link, reported that the worldwide market for drug-eluting coronary stents reached an estimated $4.2 billion in 2004 and is expected to nearly double by 2010.
According to the May 17, 2005, Boston Globe, Boston Scientific spent a mere $350 million to develop the Taxus stent but after the FDA approved the device for sale in March 2004, the company increased sales by more than $2 billion and for 2004, posted a "whopping 62 percent increase in revenue."
The Taxus is by far the company's biggest moneymaker.
Of Johnson & Johnson's seven device units, Cordis is by far the most profit enhancing. In 2005, its sales grew 24% to $4 billion.
Financial analysts estimate that the profit margin per stent sold is between 80 and 90%. The September 18, 2006, Boston Globe said that bare-metal stents run about $800 a piece, compared to $2,200 for a drug-coated stent.
Critics have long criticized the outrageous price because according to Dr Mitchell Krucoff, of Duke Clinical Research Institute, Durham, NC, in Heartwire on February 7, 2006, "In the case of first-generation DES, these are essentially bare-metal stents that have been spray-painted with plastic." The August 6, 2004 Boston Globe describes these medical devices as:
"Stents are wire mesh devices placed in arteries, which are blocked by fatty deposits. Doctors thread a tiny balloon into the artery and inflate it to clear the blockage. Then, a stent is inserted into the artery, and a second balloon expands the stent to keep the newly cleared blood vessel wide open.
"The newest stents are coated with drugs to prevent tissue buildup within the arteries, which can create fresh blockages after the stent is in place."
However, the drug-eluding stent hay-day looks like it may be short lived. The results of studies revealed over the past several months set off alarm bells among heart specialists leading many to say they will return to the use of bare-metal stents.
The studies including the BASKET-LATE study, presented at the March 2006 American College of Cardiology Scientific Sessions in Atlanta, and most recently, the Camenzind meta-analysis presented at the September 2006 European Society of Cardiology Annual Meeting/World Congress of Cardiology Meeting in Barcelona, Spain.
The results of two Swiss meta-analyses of all available data from published trials of the Cypher, a sirolimus-eluting stent, and Taxus, a paclitaxel-eluding stent, reported at the meeting in Barcelona, found not only an increased risk of late mortality and non-fatal myocardial infarction with the Cypher stent, but also an apparent increase in all cause mortality. One of the meta-analyses showed a rise in non-cardiac deaths, from cancer, sepsis and stroke. They also found a slight increase in events with the Taxus stent.
The researchers found that drug-coated stents raise the risk of fatal blood clots and said the danger is greatest for patients with J&J's Cypher, who face a 38% higher risk of adverse events.
For people who develop a clot, experts say, it can be a matter of life and death because a clot inside the stent can stop the blood flow to the heart itself.
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Recent studies have shown the new generation of drug-eluting heart stents to be associated with an increased risk of late stent thrombosis, cardiac mortality, myocardial infarction, and all cause mortality. And at the same time, they have proven to be little more effective, if any, than the older bare-metal stents that sell for a fraction of the cost.
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