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[CIT2015]生物可降解支架和RDN新发展--美国哥伦比亚大学医学中心Juan F. Granada教授专访

作者:  J.F.Granada   日期:2015/3/24 20:07:44

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编者按:继多位国际专家解读生物可降解支架的应用之后,美国哥伦比亚大学医学中心Juan F. Granada教授也介绍了自己的观点。另外,在过去遭遇滑铁卢的去肾神经化(RDN)治疗上,Granada教授认为仍需积累相关临床经验。

  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 largeis thegapbetween BRS data and it’s 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. Granada : Bioresorbable scaffolds I think have been called the 4th revolution of interventional cardiology. At the present time, I think we are building enough clinical evidence to support the safety and efficacy of these devices. The first milestone that we need to achieve is essentially prove that these devices are as safe and effective as metallic drug eluting stents. Once we prove that I think that we need to start looking at the biological benefit of these technologies. Essentially what we are thinking about is the positive vascular remodeling.

  I think what the main benefit is as the process of absorption occurs the vessel starts to dilate and what is actually called positive vascular remodeling. With the vascular remodeling happening, we expect to see less restenosis and less clinical events in patients. I think the gap is still big because we are still collecting data but as the data starts to come out with different devices and different generations of technologies, I think we are going to get closer and closer to introduce this technology into the clinical arena.

  Granada教授:生物可吸收支架被誉为介入心脏病学领域的第四次革命。我认为,目前我们正在积累足够的临床证据证实这些设备的安全性与疗效。我们首先需要至少证实生物可吸收支架与金属药物洗脱支架一样安全有效。在证实这一点后,我们可以继续观察和研究生物可吸收支架的生物学获益,如是否能实现正性血管重构。我认为,生物可吸收支架的主要益处在于,随着其吸收血管得以扩张,能够实现正性血管重构。而随着血管重构的发生,我们希望生物可吸收支架能够减少患者再狭窄及临床事件的发生。目前来说,生物可吸收支架的数据与理论构建还存在很大差距,因为我们目前仍在收集相关数据。但是,随着不同生物可吸收支架及各代技术相关数据的积累,我们将逐渐实现将生物可吸收支架真正引入临床。

  International Circulation: RDN is becoming more controversy issue after the SYMPLICITY HTN3 results released. What the net benefit would it bring to hypertension patients exclude the operators experience? How could we find something to breakthrough in terms of translational medicine or patient selection?

  《国际循环》:去肾神经化治疗在SYMPLICITY HTN-3试验后就一直受到争议。排除术者本身的经验来说,这种术式对高血压或心衰患者究竟有多大获益?如何从转化医学的角度寻求突破?

  Dr. Granada: I think in terms of renal denervation I think we have rushed into clinical studies very quickly. The first thing with renal denervation that we need to understand is renal denervation does induce and actually changes nerves around the artery meaning the effect is actually real, the effect is actually clear. The main question is how much denervation can we do to have clinical outcomes or to improve elevated blood pressure in patients. Second is what is the patient selection that we are going to be able to select in clinical trials for the technology to be efficacious so I think that we need to have atleast four major components before we go again into large clinical studies. Number 1 is to understand who is the patient that is going to respond to therapy and in order to do that we need to do studies to understand who the best patient population is. Number 2 is through experimental animal models, understand how much renal denervation we need to achieve a biological effect and number 3, which is the best technique to actually have complete denervation of the arterial wall. But I think we are getting there, there are still a lot of things that need to happen before we go into these second generation trials but I think we are accumulating the evidence to be able to be actually able to prove that renal denervation is back into the clinical arena.

  Granada教授:我认为,去肾神经化治疗开展临床研究的步伐非常快。就去肾神经化治疗而言,首先我们需要知道其能诱导和改变肾动脉周围的神经,这就意味着其作用是真实存在的。目前主要的问题是,我们到底应该去神经化至何种程度才能达到临床效果或是改善患者的高血压。其次,就是患者选择问题,我们需要在临床试验中选择对去肾神经治疗有效的患者。因此,未来我们至少需要具备下述主要条件才能进一步开展相关大型临床试验。第一,开展相关研究确定适合行去肾神经治疗的最佳人群,知晓哪些患者对去肾神经治疗有反应;第二,通过动物实验模型了解要想达到生物学效应所需的去肾神经化治疗程度;第三,确定实现动脉壁完全去神经化的最佳技术是什么。虽然我们已经开始逐步接近实现上述条件,当仍需开展大量的工作才能进行有关去肾神经化治疗的第二代试验。不过,无论如何,我们现在正在不断努力积累真正能够证实去肾神经化治疗可回归并应用于临床的证据。

 

 

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