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药物洗脱支架和裸金属支架治疗冠心病的比较研究
Drug-Eluting or Bare-Metal Stents for Coronary Artery Disease


Kaare H. Bønaa ... 心脑血管疾病 • 2016.09.29
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治疗冠心病药物洗脱支架和裸金属支架:谁优谁劣


汪道文

华中科技大学同济医学院附属同济医院

 

经皮冠状动脉内植入支架(PCI)治疗严重冠状动脉狭窄已经成为冠心病治疗最普通和最常用的方法之一。由于金属裸支架植入后刺激平滑肌和内膜增生而导致再狭窄,通过在支架上经多聚化合物(尤其是新一代丙烯多聚物和氟化多聚物)带上抗细胞增殖药物如雷帕霉素,能抑制血管内膜增殖而减少支架置入后再狭窄。虽然裸支架的应用带来了血管再内皮化延迟和后期支架内血栓的问题,但是长时间双重抗血小板治疗能够克服它。早些时候进行的EXAMINATION试验在1,498例急性ST段抬高心肌梗死患者中比较了新一代药物凃层支架和金属裸支架置入后的1年和5年临床结果,证明药物涂层支架优于裸支架1。于是形成了一个概念——所有需要支架植入的冠心病患者几乎全部接受新一代药物涂层支架(尤其在我国),由此也带来了巨额医疗费用。

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摘要


背景

目前关于当代药物洗脱支架和当代裸金属支架对死亡率、心肌梗死、再次血运重建和支架内血栓形成及生活质量产生的远期影响比较的数据有限。

 

方法

我们随机分配9,013例有稳定或不稳定型冠状动脉疾病的患者,到接受经皮冠状动脉介入(PCI)并置入当代药物洗脱支架或裸金属支架组中。在接受药物洗脱支架组中,96%的患者接受了依维莫司或佐他莫司洗脱支架。主要结局是在5年的中位随访期后,任何原因死亡和非致死性自发性心肌梗死构成的复合指标。次要结局包括再次血运重建、支架内血栓形成和生活质量。

 

结果

6年时,主要结局发生率在接受药物洗脱支架组中为16.6%,在接受裸金属支架组中为17.1%(风险比,0.98;95%可信区间[CI],0.88~1.09;P=0.66)。主要结局各组分不存在显著的组间差异。任何再次血运重建的6年发生率在接受药物洗脱支架组中为16.5%,在接受裸金属支架组中为19.8%(风险比,0.76;95% CI,0.69~0.85;P<0.001);明确的支架内血栓形成比率分别为0.8%和1.2%(P=0.0498)。两组间生活质量检测值无显著差异。

 

结论

接受PCI的患者中,在任何原因死亡和非致死性自发性心肌梗死构成的复合结局方面,接受药物洗脱支架的患者与接受裸金属支架的患者之间无显著差异。再次血运重建的发生率在接受药物洗脱支架的组中较低(由挪威研究理事会[Norwegian Research Council]等资助;NORSTENT在ClinicalTrials.gov注册号为NCT00811772)。





作者信息

Kaare H. Bønaa, M.D., Ph.D., Jan Mannsverk, M.D., Rune Wiseth, M.D., Ph.D., Lars Aaberge, M.D., Ph.D., Yngvar Myreng, M.D., Ph.D., Ottar Nygård, M.D., Ph.D., Dennis W. Nilsen, M.D., Ph.D., Nils-Einar Kløw, M.D., Ph.D., Michael Uchto, M.D., Thor Trovik, M.D., Ph.D., Bjørn Bendz, M.D., Ph.D., Sindre Stavnes, M.D., Reidar Bjørnerheim, M.D., Ph.D., Alf-Inge Larsen, M.D., Ph.D., Morten Slette, M.D., Terje Steigen, M.D., Ph.D., Ole J. Jakobsen, M.D., Øyvind Bleie, M.D., Ph.D., Eigil Fossum, M.D., Ph.D., Tove A. Hanssen, R.N., Ph.D., Øystein Dahl-Eriksen, M.D., Inger Njølstad, M.D., Ph.D., Knut Rasmussen, M.D., Ph.D., Tom Wilsgaard, Ph.D., and Jan E. Nordrehaug, M.D., Ph.D., for the NORSTENT Investigators*
Address reprint requests to Dr. Bønaa at the Clinic for Heart Disease, St. Olav’s University Hospital, N 7006 Trondheim, Norway, or at kaare.harald.bonaa@ntnu.no. *Committees, study centers, and investigators participating in the Norwegian Coronary Stent Trial (NORSTENT) are listed in the Supplementary Appendix, available at NEJM.org.

 

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