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Off-label use of drug-eluting stents linked to increased risk of stent thrombosis
By: Reuters Health
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.
纽约(路特健康)2月13日--- 《新英格兰医学》杂志比计划出版日期3月8日提前报道了关于使用药物洗脱支架治疗冠状动脉狭窄好坏的5篇研究原文和2篇社论。
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 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.
其中之一试验:来自荷兰鹿特丹Erasmus 大学的Patrick W. Serruys博士及其同事对1748名病人对4项随机试验进行了混合分析。4年中,使用西罗莫司洗脱支架和裸露金属支架组死亡、患心肌梗死或支架血栓症的病人没有明显的差别。
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.
相比之下,来自纽约哥伦比亚大学医学中心Gregg W. Stone博士和他的研究小组分析这相同的4组试验数据后发现,1年后使用西罗莫司洗脱支架和紫杉醇洗脱支架的病人要比使用裸露的金属支架的病人发生血栓症普遍的多。然而使用药物洗脱支架与血管形成手术的靶向损伤程度的降低有关,并且4年后病人死亡率或者心肌梗死率没有明显的差异。
In the third study, Dr. Bo Lagerqvist from 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.
第三项的研究项目中,来自瑞典Uppsala大学医院的Bo Lagerqvist博士及其同事跟踪6033名使用药物洗脱支架的病人和将近14000使用裸露金属支架的病人,他们估算使用药物洗脱支架,病人死亡或者心肌梗死的病人每年共升高了约0.5%-1.0%.
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.
来自哈佛医学院Donald E. Cutlip博士及其同事在波士顿发现,支架血栓症的定义已经有了一定的局限性,“它并不是千篇一律的”,因此他们对8项小的“用于统一评价的新标准化、分等级的支架血栓症”随机试验结果做了评测,结果揭示和以前使用的支架血栓症相比,发生率没有差异。
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.
最后,来自德国慕尼黑Deutsches Herzzentrum的Adnan Kastrati博士及其同事在欧洲评价了14项随机试验数据。结果表明“使用西罗莫司洗脱支架后介入治疗的需求持续减少”,并且和使用裸露的金属支架相比,病人发生支架血栓的风险性也不低。
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."
哈佛大学医学院的心脏病专家、FDA循环系统机构建议小组主席William H. Maisel在一篇社论中指出,两种因素促成了目前相互冲突的数据的产生:“不同的支架血栓症定义;病人和冠状受到损伤时关键性的差异。”
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., 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."
FDA代表Andrew Farb 和Ashley B. Boam博士说:“小组已经经过协商并且FDA一致认为,当药物洗脱支架用于经过核准的征候时,和使用裸露的金属支架相比,其形成血栓的风险性并不比其本身带来的益处既在降低反复的血管形成术方面更重要。
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)
编译 字数统计1292
纽约(路特健康)2月13日--- 《新英格兰医学》杂志比计划出版日期3月8日提前报道了关于使用药物洗脱支架治疗冠状动脉狭窄好坏的5篇研究原文和2篇社论。其中一篇评论指出“和适应性使用支架相比,非适应性使用支架和支架血栓症、心肌梗死或者死亡风险性增加相关。”人们对该论点的兴致非常高涨,因为评价用于治疗冠状动脉狭窄的裸露金属支架和药物洗脱支架安全性的反复实验产生了相冲突的结论。一些结果表明药物洗脱支架是安全有利的,然而另一些结论则强调了使用该支架具有潜在的迟发性支架血栓症的风险性。其中之一试验:来自荷兰鹿特丹Erasmus 大学的Patrick W. Serruys博士及其同事对1748名病人对4项随机试验进行了混合分析。4年中,使用西罗莫司洗脱支架和裸露金属支架组死亡、患心肌梗死或支架血栓症的病人没有明显的差别。相比之下,来自纽约哥伦比亚大学医学中心Gregg W. Stone博士和他的研究小组分析这相同的4组试验数据后发现,1年后使用西罗莫司洗脱支架和紫杉醇洗脱支架的病人要比使用裸露的金属支架的病人发生血栓症普遍的多。然而使用药物洗脱支架与血管形成手术的靶向损伤程度的降低有关,并且4年后病人死亡率或者心肌梗死率没有明显的差异。第三项的研究项目中,来自瑞典Uppsala大学医院的Bo Lagerqvist博士及其同事跟踪6033名使用药物洗脱支架的病人和将近14000使用裸露金属支架的病人,他们估算使用药物洗脱支架,病人死亡或者心肌梗死的病人每年共升高了约0.5%-1.0%.来自哈佛医学院Donald E. Cutlip博士及其同事在波士顿发现,支架血栓症的定义已经有了一定的局限性,“它并不是千篇一律的”,因此他们对8项小的“用于统一评价的新标准化、分等级的支架血栓症”随机试验结果做了评测,结果揭示和以前使用的支架血栓症相比,发生率没有差异。最后,来自德国慕尼黑Deutsches Herzzentrum的Adnan Kastrati博士及其同事在欧洲评价了14项随机试验数据。结果表明“使用西罗莫司洗脱支架后介入治疗的需求持续减少”,并且和使用裸露的金属支架相比,病人发生支架血栓的风险性也不低。基于学院的试验、Meta分析、新闻的发布引起的恐慌,美国FDA召集一建议小组来综合分析2006年12月的数据。哈佛大学医学院的心脏病专家、FDA循环系统机构建议小组主席William H. Maisel在一篇社论中指出,两种因素促成了目前相互冲突的数据的产生:“不同的支架血栓症定义;病人和冠状受到损伤时关键性的差异。”他也指出这样一个事实:一定期限性的药物洗脱支架多达60%用于“复杂的情况(如多支血管病变疾病或者急性心肌梗死)或者复杂的损伤(如隐静脉旁路移植、分叉损伤或者长期的完全闭塞)。FDA代表Andrew Farb 和Ashley B. Boam博士说:“小组已经经过协商并且FDA一致认为,当药物洗脱支架用于经过核准的征候时,和使用裸露的金属支架相比,其形成血栓的风险性并不比其本身带来的益处既在降低反复的血管形成术方面更重要。因此,病人病情稳定并且没有复杂的冠状动脉狭窄时限定病人使用药物洗脱支架很有可能降低潜在的支架血栓形成风险性。FDA也推荐介入治疗后至少延长一年对病人进行双重抗血小板治疗。现在每人看来都认为有必要对药物洗脱支架的好坏作更步的研究;一些病人适合用这样的支架,并且抗血小板治疗需要延长合适的时间。
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