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【medical-news】药物支架——效果好还是不好
2/13/2007
By: Reuters Health
http://www.auntminnie.com/index.asp?Sec=sup&Sub=car&Pag=dis&ItemId=74595
NEW YORK (Reuters Health), Feb 13 - Ahead of its scheduled publication date of March 8, the New England Journal of Medicine has released five original articles and two editorials regarding the risk and benefits of drug-eluting stents for treatment of coronary artery stenosis.
One of the commentaries points out that "as compared with on-label use, off-label use is associated with increased risks of stent thrombosis and death or myocardial infarction (MI)."
Interest in this issue is high, because the multiple trials that have evaluated the safety of drug-eluting stents compared with bare-metal stents for treatment of coronary artery stenosis have yielded conflicting results. Some have affirmed the safety and benefits of drug-eluting stents, while others underscored the risk of potentially fatal late stent thrombosis.
In one of the trials, Dr. Patrick W. Serruys, from Erasmus University in Rotterdam, Netherlands, and colleagues performed a pooled analysis of 1,748 patients in four randomized trials. At four years, there were no significant differences between sirolimus-eluting stents and bare-metal stents in rates of death, MI, or stent thrombosis.
In contrast, Dr. Gregg W. Stone, from Columbia University Medical Center in New York City, and his team analyzed data from the same four trials. They found that stent thrombosis after one year was more common with both sirolimus- and paclitaxel-eluting stents than with bare-metal stents. However, drug-eluting stents were both associated with reductions in target-lesion revascularization and no significant differences in rates of death or MI after four years.
In the third study, Dr. Bo Lagerqvist from Uppsala University Hospital in Sweden and colleagues followed 6033 patients treated with drug-eluting stents and nearly 14,000 treated with bare-metal stents. They estimate that, when drug-eluting stents were used, the composite of death or MI rose by 0.5 to 1.0 percentage point higher per year.
Dr. Donald E. Cutlip, from Harvard Medical School, and associates in Boston observed that definitions of stent thrombosis have been restrictive and not "uniform in manner." They therefore evaluated results of eight small randomized trials using "a new standardized, hierarchical definition of stent thrombosis for uniform evaluation of events," which revealed no significant difference in the incidence of stent thrombosis based on type of stent that was used.
Finally, Dr. Adnan Kastrati, from Deutsches Herzzentrum in Munich, Germany, and colleagues in Europe evaluated data from 14 randomized trials. Their results showed a "sustained reduction in the need for reintervention after the use of sirolimus-eluting stents," and a risk of stent thrombosis no lower than observed with bare-metal stents.
Based on the flurry of academic trials, meta-analyses, and press releases, the U.S. Food and Drug Administration (FDA) convened an advisory panel meeting to review the data in December 2006.
In an editorial, Dr. William H. Maisel, a cardiologist at Harvard Medical School and chair of the FDA Circulatory System Devices Advisory Panel, points out two factors that contributed to the conflicting data, "variable definitions of stent thrombosis and key differences in the characteristics of patients and coronary lesions."
He also comments on the fact that more than 60% of the time, drug-eluting stents are used in patients with "complex conditions (such as multivessel disease or acute MI) or with complex lesions (for example, saphenous-vein bypass grafts, bifurcating lesions, and chronic total occlusions)."
Dr. Andrew Farb and Ashley B. Boam, representatives of the FDA, write in a separate editorial, "The panel agreed, and the FDA concurs, that when drug-eluting stents are used for their approved indications, the risk of thrombosis does not outweigh their advantages over bare-metal stents in reducing the rate of repeated revascularization."
Thus, restricting the use of drug-eluting stents to patients in stable condition with noncomplex coronary stenoses is likely to reduce the risk of late stent thrombosis. The FDA also recommends prolonged dual antiplatelet therapy for at least a year following the intervention.
Everyone seems to agree on the necessity of more research on the risks and benefits of drug-eluting stents, patients for whom such stents are appropriate, and optimal duration of antiplatelet therapy.
By Karla Gale
Last Updated: 2007-02-12 17:00:29 -0400 (Reuters Health) 本人已认领该文编译，48小时后若未提交译文，请其他战友自由认领。 Off-label use of drug-eluting stents linked to increased risk of stent thrombosis
非适应症性使用药物洗脱支架与诱发支架血栓症增加相关
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