International Circulation: Could you about the appropriate usage pendulum， especially when it comes to trial designs and inclusion criteria?
　《国际循环》：您能否谈谈肾动脉支架植入术的适当应用，尤其是当它涉及到试验设计和入选标准时？
　Dr. Stephen Textor: There is a history worth knowing. One is that the detection of renal artery stenosis has been increasing enormously because of good imaging. Advances in Dopler ultrasound， including angiography as part of coronary studies， and CT-angiograms and MR-angiograms are finding that severe renal vascular disease is much more common than what people thought. The data are good. Somewhere between 10-30% with clinical coronary or aortic disease with have a high grade renal artery disease. Out of the general belief that while there is a lot of untreated hypertension and that it is better to open renal arteries， there has been a four-fold increase in the use of endovascular stents in renal arteries between 1995 and 2005. Medicare did a survey in 2007 to ask what benefit are getting from this? Is blood pressure improving? Are we preventing adverse events? The drug therapy has improved， so the need for the trials is pretty clear. The first small trials were a bit ambiguous. There were design flaws， they were small， and they were not seeing major benefits to dilating and stenting renal arties. That is what led to these trials. There have been four or five undertaken， the two main ones， one called STAR and the other ASTRO. Both came out in 2009， but neither of them identified， in the groups they studies， a major benefit in terms of kidney function or even blood pressure. Both of them had a few complications. The implication was that there was not much benefit and that there are some risks， we should be doing a lot less stenting. I believe that is the reason behind the drop-off. If you look at the trials， they are either small (it is difficult to know the dominator)， but most importantly， when they looked at the STAR candidates， they were screened by non-invasive tests and at the time of angiography， more than a quarter were not treated because they could not find a real disease. They were overestimating vascular lesions. That is a serious problem in STAR， the real conclusion from that trial is that there is no benefit from treating people without that disease. ASTRO was less serious， though a fair group， about 40%， had only a modest disease of 50-70% occlusion. This is not thought to be a hemodynamic threat to the kidney. People are quite concerned about that. Part of the data that accompanies this is that the events rates over the course of the trial have been low. This underscores the idea that people entered in these trials really were not that affected by the disease. That has been the concern. The word on the street is that the trials up until now have been negative， there is not much benefit， the drugs are decent， so people have suggested treating medically and avoid stenting with the exception of very specific groups.
　Dr. Stephen Textor：有一段值得了解的历史。一个是因为良好的成像，肾动脉狭窄的检出一直在迅猛增加。Dopler超声（包括作为冠状动脉研究一部分的血管造影）以及CT血管造影和MR-血管造影的进展发现，严重肾血管疾病比人们想像的更为常见。数据是好的。有临床冠状动脉或主动脉瓣疾病的患者10％~30％有高级别的肾动脉疾病。普遍认为，虽然有很多未经治疗的高血压，最好是打开肾动脉，1995年至2005年间，血管内支架在肾动脉的应用增加了4倍。医疗保险在2007年做了一个调查，质询从中获得的益处是什么？血压有否改善？我们预防了不良事件吗？药物治疗已有改善，所以对试验的需求是相当清楚。最初的小规模试验结果有点儿不够明确，有设计上的缺陷，他们规模小，且他们没有观察肾动脉扩张和支架置入术的重大获益，这是开展这些试验的原因，已经有四、五项试验正在进行中，两项主要的，一项称为STAR，另一个项是ASTRO，都是在2009年发表，但在肾功能甚至血压方面，在他们研究的群体中他们都未确定主要的益处。他们都有一些并发症，其含义是，没有太多的获益，且有一定的风险，我们应该做的支架置入术要少很多。我认为这是脱落背后的原因。如果你看一下这些试验，他们或者规模小（很难知道支配者），但最重要的是，当他们观察STAR候选者，他们是通过非侵入性检查筛选出来，且在血管造影时，超过一季度未治疗，因为他们未能发现真正的疾病，高估了血管病变。在STAR中，这是一个严重的问题，该试验真正的结论是，治疗没有这种疾病的人未得到任何益处。ASTRO没那么严重，虽然分组是公平的，约40％只有闭塞50％~70％的轻度疾病。这被认为对肾脏血流动力学不构成威胁。这也是人们关注的一点，伴随这一点的部分数据是，试验过程中的事件率一直较低。这强调了以下想法：进入这些试验的人的确未受该疾病影响。这已经引起了关注，显而易见的是这些试验迄今为止一直是阴性的，没有带来多少好处，药物是适合的，因此人们建议药物治疗并避免支架置入术，除非非常特殊的群体。

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