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