Drug-coated stents, sold in the United States by Johnson & Johnson and Boston Scientific Corp have hailed as a major advance just 3 years ago are now being blamed to cause blood clots and other complications in certain high-risk cases and patients.
What is stent? It is a short narrow metal tube in the form of a mesh that is inserted into artery to keep the previously blocked passageway open. Using drug coating on the stent can lower the chances of an artery closing again, a problem reported with about a quarter of stents without drug.
United States advisers have now started to consider the risks of drug-coated stents implanted in millions of heart patients, examining evidence showing the devices may lead to dangerous blood clots.
This surfaced problem is viewed as a public issue of great importance and the agency concerned does not want to wait until they had every piece of information before trying to provide guidance about the stent use. The Food and Drug Administration (FDA) has in fact set up a panel of outside experts to go through varying studies and provide advice about the level of risk and which patients should be candidates for drug-coated stents.
But here is the key question: how can we weight the chances of blood clots against the risk of re-closing from a bare stent? A preliminary FDA staff analysis concluded that there was a “small but significant" risk of blood clots appearing a year or more after a drug-coated stent is implanted. Nevertheless, it was not clear if the long-term risk of dying or having a heart attack was elevated.
Nearly 6 million patients worldwide have received drug-coated stents and the market is worth nearly US$6 billion a year, according to an estimate by JP Morgan analysts.
Makers of drug-coated stents maintain their stands that the drug-coated versions continue to offer advantages over bare-metal alternatives. Boston Scientific has revealed that it found a slight increase in blood clots with its Texus drug-coated stent, but no higher rate of heart attacks or deaths. Johnson & Johnson has announced that the data so far shows no significant difference in the risk of blood clots between its Cypher drug-coated stent and bare-metal versions.
In the light of the possible danger of blood clots caused by drug-coated stents, Abbott Laboratories and Medtronic Inc, which market their versions of drug-coated stents in other countries, are aiming for United States launches as early as the middle of next year.
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