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Use
of Drug-Eluting Stents Declines at Some Hospitals |
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| June 22, 2006 -- The stock prices for Boston Scientific and Johnson & Johnson dropped today, as the Wall Street Journal published an article reporting that some hospitals, including Washington Hospital Center (Washington, DC) and Cedars-Sinai (Los Angeles) are using less drug-eluting stents in favor of the older bare metal stents. While the article by Sylvia Pagan Westphal set off a "mini-media-frenzy" (see "J&J defends safety of Cypher stent" from Reuters and "Boston Scientific Say Not Seeing Less Stent Use" from AP) the concern among cardiologists about the occurrence rate for stent thrombosis first surfaced three years ago, after the introduction of the CYPHER sirolimus-eluting stent, manufactured by Johnson & Johnson / Cordis (see our article, "Unraveling the CYPHER"). The issue was looked at and data from clinical trials showed that the stent thrombosis rate was no different from that seen in bare metal stents. However, the concern over the safety record of drug-eluting stents has been bolstered somewhat recently by several studies and journal articles. The Wall Street Journal story cites "a recent Swiss study" that found higher cardiac death and heart attack rates in patients who had received the drug-eluting type stent. Angioplasty.Org has previously reported on this study, presented at the American College of Cardiology meeting in March. The BASKET-LATE study, which received virtually no coverage in the press, indeed showed a higher rate of serious complications in the drug-eluting stent category. The study authors did not surmise "why" this occurred, and their presentation was not without controversy, with at least one panel member disputing their methodology and results. A second article, authored by physicians at Cedars-Sinal Medical Center, appears in this week's Annals of Internal Medicine and it concludes in no uncertain terms that:
Part of the problem is that drug-eluting stents work by inhibiting the growth of cell "scar tissue" inside of the stent, thus lowering the restenosis (reblockage) rate. But if the cells that line the interior of the artery are inhibited too much, then the normal creation of a covering layer of endothelial cells is delayed and the uncovered stent remains a "foreign object" around which platelets are prone to gather -- thus producing a blood clot, or thrombus, which can cut off the blood flow quite suddenly, and is fatal in almost 1/3 of cases. The risk of thrombosis is lessened greatly by the use of antiplatelet drugs, such as clopidogrel (Plavix), ticlopidine (Ticlid) and aspirin, medications which all drug-eluting stent patients are supposed to stay on for 3-6 months, or longer. The problem arises when the patients stop the medicines early, before the artery lining has healed. Then the stent thrombosis rate can go higher: two, three or four times what was observed in the carefully-conducted clinical trials. And there is some evidence that in the real world, patients don't in fact stay on these drugs for the required time. A study, published in this week's Circulation, reported that 1 in 7 heart attack patients who are treated with drug-eluting stents stop their medications within 30 days, a finding that surprised doctors. Device manufacturers replied in the Wall Street Journal article that they have not seen a drop-off in drug-eluting stent usage. In fact, some doctors report increased usage, since the newer coated stents have shown great advantages in patients who did not do well with the older devices, particularly diabetics. related
stories: BASKET-LATE Study Shows Higher Rate of Cardiac Death and Heart Attack for Drug-Eluting Stents vs. Bare Metal Stents -- Angioplasty.Org
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