Cardiology Groups Stress Year-Long Antiplatelet Therapy For Stent Patients
"Strong" consideration should be given to avoiding drug-eluting stents in patients who are not expected to continue dual antiplatelet therapy for a full 12 months, according to a 1science advisory posted online by leading medical organizations
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FDA's Circulatory System Devices Panel recommends extended use of Sanofi-Aventis/Bristol-Myers Squibb's Plavix (clopidogrel) for reducing risk of thrombosis associated with drug-eluting stents. During its Dec. 7-8 meeting, the panel suggested FDA align DES labeling with American Heart Association guidelines that the antiplatelet therapy be taken for up to a year if a patient does not exhibit excessive bleeding. An observational study published in the Dec. 5 Journal of the American Medical Association found better outcomes were achieved the longer patients took Plavix, up to one year. FDA is considering changing DES labeling to reflect the need for anticlotting regimens that last longer than the three months recommended for Johnson & Johnson/Cordis' Cypher sirolimus-eluting stent and the six months recommended for Boston Scientific's Taxus paclitaxel-eluting stent...
Results form the 2,287-patient COURAGE trial presented the American College of Cardiology meeting should give physicians more to think about before moving forward with percutaneous coronary intervention in stable heart disease patients, researchers say.
FDA will post advisory committee briefing materials on its Web site at least two business days in advance of meetings, doubling the current lead time in an effort to enhance transparency, according to a 1draft guidance released last week