Panel says wide use of drug-coated stents risky
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GAITHERSBURG, Maryland  - Drug-coated heart stents are more likely to cause blood clots and other complications in certain high-risk cases and patients and doctors should be warned, a panel of medical experts advised on Friday.
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NEW YORK  - Heart patients who are anemic  before they undergo percutaneous coronary intervention (PCI)  may be at increased risk of death following the procedure,  according to a report in Journal of the American College of  Cardiology.
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BARCELONA -- Specialists expressed concerns yesterday that drug-coated heart stents -- metal-mesh tubes used to prop open coronary arteries -- might increase the chances of potentially fatal blood clots.
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Even some heart attack patients would be better off if their doctors avoided using drug-coated stents to open their clogged arteries, an international study found, raising new concerns about the devices.
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Results of a study showing patients with acute heart attacks are more likely to die if given a drug-coated stent than a bare metal one are out of line with other findings, stent maker Johnson & Johnson said on Tuesday.
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Patients who get the leading drug-coated stents to prop open coronary arteries rather than bare-metal stents run no higher risk of death, according to a new report by a multinational team of doctors.
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A Food and Drug Administration panel tomorrow will consider one of the most urgent questions in medicine: what to do about the risk of blood clots caused by drug-coated stents, tiny medical devices implanted in the arteries of millions of people.
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Vioxx . Ritalin. Drug-eluting stents . Those popular drugs and medical devices are on a growing list of therapies used by millions of people that have shown up on the radar of Dr. Steven E. Nissen , a prominent heart specialist.
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Federal advisers heard conflicting data today about the safety of new drug-oozing stents used to keep clogged arteries open as the experts struggled to advise government regulators about whether the risks of the devices outweigh their benefits for millions of patients.
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Blood clotting is four to five times more likely in patients getting drug-coated heart devices known as stents, compared to the older bare-metal variety, according to a large data analysis released on Wednesday.
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Drug-coated stents that prop open the arteries of about 3 million people in the U.S. don't increase the risk of heart attack or death when used as labeled but may put patients at risk for blood clots, health advisers said Thursday.
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Stent makers and cardiologists said reports at this yearâs major meeting of European cardiologists bolstered their confidence in the safety of the newer drug-coated versions of the devices.
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Boston Scientific Corp. found a slightly higher risk of blood clotting in patients implanted with its newer drug-coated stents compared with older bare-metal versions, a company spokesman said Thursday.
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The study suggested that a widely used heart-surgery medicine might increase the risks of death and stroke.
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Some cardiologists suggest drug-coated stents carry a higher risk of potentially fatal blood clots than older, bare-metal stents.
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A Texas jury has ruled that Boston Scientificâs drug-coated stents infringe a 1997 patent issued to a radiologist and has awarded the inventor $431 million in damages, Boston Scientific said.
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Bypass surgery remains the best option for heart patients with more than one clogged artery, according to the first big study to compare bypasses with drug-coated stents. In the study, heart attack and death rates were lower among people who had surgery than those given artery-opening balloon angioplasty and stents. It is latest setback for drug-coated stents, which have revolutionized heart care and have been implanted in about six million people worldwide. The study is in Thursdayâs New England Journal of Medicine.