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[CIT2015]生物可吸收支架有望解决支架内血栓问题--美国纽约西奈山医学院Roxana Mehran教授专访

作者:  R.Mehran   日期:2015/3/24 20:01:37

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编者按:支架新技术和支架术后并发症是CIT历年来讨论的重要话题。作为第四个里程碑,生物可吸收支架的未来充满希望,同时有望解决支架内血栓问题。已有的预防支架内血栓试验对未来抗栓治疗也提供了线索。对以上两个话题,《国际循环》在CIT 2015现场采访到美国纽约西奈山医学院Roxana Mehran教授。

  International Circulation: Bioabsorbable stents can be called as the new milestone in the history of PCI, but it is at the beginning of development. How large is the gap between BRS data and its theory building in your opinion?

  《国际循环》:生物可吸收支架堪称介入史上的第四个里程碑,但仍处于起步阶段。目前已有少数支架在临床使用,您认为当前生物可吸收支架数据与理论构建还有多少差距?

  Dr. Mehran : Thank you very much for that important question. I think that first of all thanks for having me and giving me the opportunity to speak to International Circulation. I am very excited about bioresorbable scaffolds. I think that they are truly disruptive technology and while we are in the beginning of the development I think we will have incredible data coming forth in the next year or two with tremendously well designed large scale prospective randomized trials. While we are always looking for the superiority over what we already have, I think by the virtue of a bioresorbable scaffold that is already superior to a metallic stent, I think the only thing they need to show is that they are no different than the metallic stents, then I think if they are no different, they are only going to be better because they resorbable and they will go away. I think that concept of bioresorbable scaffold is so very intriguing and incredible, it truly will be a disruptive technology down the road. We are in the beginning of development so there will be lots of bumps in the road if you will, but I think the road is clear and we are very lucky that the industry has spent lots of time and effort and great science behind this technology to the point of delivering the best care to the patients so I think we have to be very thankful and very grateful for our industry colleagues who are spending the time and effort to actually develop the very next best technology for our patients.

  Mehran教授:首先感谢你们对我进行采访并给我提供与国际循环受众进行交流的机会。提起生物可吸收支架,我感到非常兴奋。我认为,生物可吸收支架是真正的颠覆性技术。在其发展之初的时候,我就认为通过开展大量精心设计的大型前瞻性随机研究能在一两年内获得惊人的数据。就与现有支架相比生物可吸收支架的优越性而言,我认为单就其支架具有可吸收性这一点而言就已经要优于金属支架,我们唯一需要做的就是证实其应用效果与金属支架没有差异。如果两者效果确实无差异,则生物可吸收支架可能要更好些,因为它们具有可吸收性,最终会自行消失。我认为,生物可吸收支架的理念是非常奇妙和令人难以置信的,真的是一项具有颠覆性的技术。不过,目前来说,生物可吸收支架仍处于起步发展阶段,因此还有很多曲折的道路需要走,但是,总体来说前途是光明的。非常幸运的是,在生物可吸收支架方面,业界花了很多的时间与精力作了大量的努力,开展了大量的科学研究,以期能够为患者提供最佳治疗。所以,我认为我们应该感谢那些花了大量时间和精力来为患者研发生物可吸收支架的业界同仁。

  International Circulation: Bivalirudin can reduce the adverse clinical events effectively based on BRIGHT trial. According to the data, could you introduce your prospective in anticoagulant therapy of the patients who received primary PCI?

  《国际循环》:去年公布的BRIGHT 试验公布,比伐卢定可有效地减少基本不良临床事件。对直接PCI患者的抗凝策略,结合该试验结果您有什么见解?

  Dr. Mehran: I think the question of which anti-thrombic therapy is the best during STEMI is one that is very hot I would say and in an incredibly topical area. We have now greater than 20,000 patients with bivalirudin in several different clinical studies. We know of HORIZONS AMI study obviously, we started it with showing that bivalirudin was associated with a reduction in bleeding and mortality which was huge, and then there were three studies, one was called EUROMAX with early bivalirudin infusion in Europe, followed by the BRIGHT study which was a fantastic study run here by Professor Han Yaling, and then of course the HEAT PPCI study which was a single center but a very well conducted large scale study with over 1000 patients with consecutive patients with STEMI. All of these have the control arm be bivalirudin versus the heparin model therapy. In EUROMAX it was only a few patients and in the other two they had a model therapy for heparin. In the end, everything was consistent except for HEAT PPCI. HEAT PPCI showed higher ischemic complications and similar bleeding, it was really an outlier and we were all like “Wow, maybe that is what it is” and we just had the MATRIX study presented at the American College of Cardiology which actually showed consistency with the prior studies so I think in the end bivalirudin is an excellent option that has been associated with a reduction in bleeding across the board. There is a trend or at least the morality is in the right direction for bivalirudin and then lastly you are not going to have a higher ischemic issues except for more stent thrombosis and so that will require some level of scrutiny of prolonged infusion and more potent antiplatelet agents and I think in the end it could be an excellent alternative to anticoagulation treatments in the cath lab.

  Mehran教授:STEMI的最佳抗栓治疗是一个热点话题。目前在数项不同的临床研究中,应用比伐卢定的患者已经超过了20000例。最初开展的HORIZONS AMI研究显示,比伐卢定可显著降低出血及死亡风险。后来人们又开展了三项有关比伐卢定与肝素的对比研究。它们分别是在欧洲开展的有关早期输注比伐卢定的EUROMAX研究,中国的韩雅玲教授开展的BRIGHT研究以及连续入选了1000余例STEMI患者的单中心大规模研究HEAT PPCI研究。其中,EUROMAX研究入选的患者数量较少,另外两项研究建立了肝素治疗模型。除HEAT PPCI研究外,其他研究获得了一致的结果。HEAT PPCI研究显示,与肝素相比,比伐卢定可增加缺血并发症,不增加出血风险。这一例外,让人们开始怀疑可能比伐卢定并不优于肝素。但是,ACC年会上发布的MATRIX研究结果与既往其他研究结果一致。所以,我认为比伐卢定是一种很好的抗凝治疗选择,能降低出血风险。与肝素相比,其具有降低出血事件之趋势,并至少可以降低死亡风险,虽可增加支架内血栓形成但不会增加缺血事件,因此需要对延长输注及应用更强效的抗血小板药物进行审查。我认为,从目前来看,总的来说,比伐卢定有望成为导管室抗凝治疗的良好替代之选。

 

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生物可吸收支架里程碑比伐卢定BRIGHT研究抗凝

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