【medical-news】药物洗脱支架并未增加心脏病发作或死亡风险，其受益大于血栓风险
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Drug-Eluting Stents Do Not Increase Risk Of Heart Attack Or Death, Benefits Outweigh Increased Blood Clot Risk, FDA Advisory Panel States
Main Category: Medical Devices News
Article Date: 12 Dec 2006 - 17:00pm (PST)
There is no conclusive evidence that drug-eluting stents increase the risk of heart attack or death when used within the scope of their FDA approval, an FDA advisory panel said Thursday, the Washington Post reports (Stein, Washington Post, 12/8). Drug-coated stents, which are sold in the U.S. by Boston Scientific and Johnson & Johnson, are designed to prevent scar tissue from forming in arteries after angioplasty. However, recent studies have suggested the devices might increase the risk of blood clots compared with bare-metal stents (Kaiser Daily Health Policy Report, 12/4). FDA asked the advisory panel to examine the risks of blood clots, heart attack and death for approved and off-label use of drug-coated stents compared with older bare-metal stents (Bridges, AP/Macon Telegraph, 12/8). Drug-coated stents are approved by FDA for use in patients with simple artery blockages, but the agency estimates that at least 60% of procedures involving the devices are performed in patients with more complex conditions, such as heart attacks, multiple blockages requiring more than one stent or blockages in more than one branch of an artery (Wilde Mathews/Winslow, Wall Street Journal, 12/8). The panel will address off-label use on Friday (AP/Macon Telegraph, 12/8).
Findings
Panel Chair William Maisel of Beth Israel Deaconess Medical Center said, "The message is: Drug-eluting stents are safe, and the safety concerns are far outweighed by the evidence of a clinical benefit." Maisel and other panel members noted that this finding applies only to patients for whom the devices are approved (Washington Post, 12/8). The panel did not take formal votes on any issues, saying that the available data were insufficient to form definitive answers on all of FDA's questions. Regarding blood clots, Maisel said the "magnitude of the risk is uncertain" (Wilde Mathews/Winslow, Wall Street Journal, 12/8). According to the panel, available data on drug-coated stents come from studies that were not sufficiently designed to provide conclusive evidence of whether an increased risk of clots would translate into an increase in heart attacks or deaths (Washington Post, 12/8). In addition, the panel said it is unclear whether the potential increased risk of blood clots continues for several years after the stents are implanted or if it declines over time (Wilde Mathews/Winslow, Wall Street Journal, 12/8). Panel member Steven Nissen, president of the American College of Cardiology, said, "I have seen nothing to date that indicates that the problem goes away." He added, "It's a bit scary if the rate is constant. In the long run, it may not be such a good bargain" (Washington Post, 12/8).
Anticlotting Drugs
Panel members also discussed whether patients with drug-coated stents should take anticlotting medications for longer than six months after surgery, the length of time that is currently recommended. Some members said labels for drug-coated stents should state that taking the medications for longer than six months might help prevent future clots. According to the Journal, one concern is over patients who need dental work, knee surgery or other operations, because doctors usually recommend that patients stop taking blood thinners before such procedures. Halting anticlotting treatment "can be risky with drug-coated stents," the Journal reports (Wilde Mathews/Winslow, Wall Street Journal, 12/8).
Manufacturers
Boston Scientific and J&J representatives told the panel that any potential increase in the risk of blood clots is offset by the ability of drug-coated stents to reduce repeat surgical procedures, which carry their own risks (Washington Post, 12/8). FDA on Friday is expected to seek the panel's recommendations on clinical trials involving stents on the market or awaiting approval (AP/Macon Telegraph, 12/8).
Lawsuits
In related news, the Journal on Friday examined how personal-injury lawyers are "paying close attention" to the FDA panel's findings because of the potential for liability claims against stent manufacturers. Some patients with drug-coated stents allege the manufacturers failed to warn them about the potential risk of blood clots or about itching problems after implantation. Although a few lawsuits already have been filed, it is unlikely that potential liability issues related to drug-coated stents "will provide plaintiffs' attorneys with their next Vioxx," according to the Journal (Johnson/Won Tesoriero, Wall Street Journal, 12/8).
Broadcast Coverage
APM's "Marketplace Morning Report" on Thursday reported on the review of drug-coated stents. The segment includes comments from Candice Mahboubi of Millennium Research Group (Palmer, "Marketplace Morning Report," APM, 12/7). A transcript and audio of the segment are available online. In addition, NPR's "All Things Considered" on Thursday reported on FDA's consideration of drug-coated stent safety. The segment includes comments from Michael Domansky, a cardiologist at NIH; Ray Gibbons, a cardiologist at the Mayo Clinic and president of the American Heart Association; and David Kong, a cardiologist at Duke University (Hamilton, "All Things Considered," NPR, 12/7). A transcript and audio of the segment are available online.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
http://www.medicalnewstoday.com/medicalnews.php?newsid=58536
Main Category: Medical Devices News
Article Date: 12 Dec 2006 - 17:00pm (PST)
There is no conclusive evidence that drug-eluting stents increase the risk of heart attack or death when used within the scope of their FDA approval, an FDA advisory panel said Thursday, the Washington Post reports (Stein, Washington Post, 12/8). Drug-coated stents, which are sold in the U.S. by Boston Scientific and Johnson & Johnson, are designed to prevent scar tissue from forming in arteries after angioplasty. However, recent studies have suggested the devices might increase the risk of blood clots compared with bare-metal stents (Kaiser Daily Health Policy Report, 12/4). FDA asked the advisory panel to examine the risks of blood clots, heart attack and death for approved and off-label use of drug-coated stents compared with older bare-metal stents (Bridges, AP/Macon Telegraph, 12/8). Drug-coated stents are approved by FDA for use in patients with simple artery blockages, but the agency estimates that at least 60% of procedures involving the devices are performed in patients with more complex conditions, such as heart attacks, multiple blockages requiring more than one stent or blockages in more than one branch of an artery (Wilde Mathews/Winslow, Wall Street Journal, 12/8). The panel will address off-label use on Friday (AP/Macon Telegraph, 12/8).
Findings
Panel Chair William Maisel of Beth Israel Deaconess Medical Center said, "The message is: Drug-eluting stents are safe, and the safety concerns are far outweighed by the evidence of a clinical benefit." Maisel and other panel members noted that this finding applies only to patients for whom the devices are approved (Washington Post, 12/8). The panel did not take formal votes on any issues, saying that the available data were insufficient to form definitive answers on all of FDA's questions. Regarding blood clots, Maisel said the "magnitude of the risk is uncertain" (Wilde Mathews/Winslow, Wall Street Journal, 12/8). According to the panel, available data on drug-coated stents come from studies that were not sufficiently designed to provide conclusive evidence of whether an increased risk of clots would translate into an increase in heart attacks or deaths (Washington Post, 12/8). In addition, the panel said it is unclear whether the potential increased risk of blood clots continues for several years after the stents are implanted or if it declines over time (Wilde Mathews/Winslow, Wall Street Journal, 12/8). Panel member Steven Nissen, president of the American College of Cardiology, said, "I have seen nothing to date that indicates that the problem goes away." He added, "It's a bit scary if the rate is constant. In the long run, it may not be such a good bargain" (Washington Post, 12/8).
Anticlotting Drugs
Panel members also discussed whether patients with drug-coated stents should take anticlotting medications for longer than six months after surgery, the length of time that is currently recommended. Some members said labels for drug-coated stents should state that taking the medications for longer than six months might help prevent future clots. According to the Journal, one concern is over patients who need dental work, knee surgery or other operations, because doctors usually recommend that patients stop taking blood thinners before such procedures. Halting anticlotting treatment "can be risky with drug-coated stents," the Journal reports (Wilde Mathews/Winslow, Wall Street Journal, 12/8).
Manufacturers
Boston Scientific and J&J representatives told the panel that any potential increase in the risk of blood clots is offset by the ability of drug-coated stents to reduce repeat surgical procedures, which carry their own risks (Washington Post, 12/8). FDA on Friday is expected to seek the panel's recommendations on clinical trials involving stents on the market or awaiting approval (AP/Macon Telegraph, 12/8).
Lawsuits
In related news, the Journal on Friday examined how personal-injury lawyers are "paying close attention" to the FDA panel's findings because of the potential for liability claims against stent manufacturers. Some patients with drug-coated stents allege the manufacturers failed to warn them about the potential risk of blood clots or about itching problems after implantation. Although a few lawsuits already have been filed, it is unlikely that potential liability issues related to drug-coated stents "will provide plaintiffs' attorneys with their next Vioxx," according to the Journal (Johnson/Won Tesoriero, Wall Street Journal, 12/8).
Broadcast Coverage
APM's "Marketplace Morning Report" on Thursday reported on the review of drug-coated stents. The segment includes comments from Candice Mahboubi of Millennium Research Group (Palmer, "Marketplace Morning Report," APM, 12/7). A transcript and audio of the segment are available online. In addition, NPR's "All Things Considered" on Thursday reported on FDA's consideration of drug-coated stent safety. The segment includes comments from Michael Domansky, a cardiologist at NIH; Ray Gibbons, a cardiologist at the Mayo Clinic and president of the American Heart Association; and David Kong, a cardiologist at Duke University (Hamilton, "All Things Considered," NPR, 12/7). A transcript and audio of the segment are available online.
"Reprinted with permission from http://www.kaisernetwork.org. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at http://www.kaisernetwork.org/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork.org, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.
http://www.medicalnewstoday.com/medicalnews.php?newsid=58536
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