International Circulation:  To evaluate the efficacy of new generation of DES， what do you think is a reference standard， angiographic measurement of clinical endpoints?
《国际循环》：在评价新一代DES疗效的时候，您认为参考标准是什么？血管造影结果还是临床终点？

Mark Turco:   This is a great question because clinical trial design is very important when we are evaluating DES.  One of the things that have been problematic is that many of the endpoints have been done after angiographic follow-up has occurred.  We do need to have angiographic follow-up on patients but the angiographic follow-up needs to occur after a clinical endpoint so we get away from this issue of oculo-stentotic reflex where us， as the interventionalists， intervene on lesions that may not need to be intervened on and may not be clinically significant.  That is one point.  Newer trials are all going to have the angiographic endpoints after the clinical endpoints.  Also what I think we have learned， especially coming out of the recent TCT meeting， is that we need long-term data， one or two years is not enough.  We still need to look at 3， 4， and 5-year data with DES.  We are always going to look， from an efficacy standpoint， at late loss and that will tell us whether a DES works or does not work.  That is important.  As we are pretty clear now， all of the ALAMUS platforms give us that late loss between 0.1 to 0.2， and then the PACLET-TAXAL gives us the late losses in the range of 0.3 to 0.4.
Mark Turco 教授：这是一个很大的问题，因为在我们评价DES的时候，临床试验的设计是非常重要的。一直存在的众多问题中的一个就是，在血管造影随访后，也一直在进行许多终点测定。我们确实需要随访患者的血管造影结果。但是血管造影随访需要在临床终点随访之后，这样我们才能消除oculostenotic reflex问题，因为介入医生对某些病变的干预可能并不必要，可能没有很大的临床意义。较新的临床试验都在随访临床终点之后检查血管造影终点。我的这些观点也是通过学习得来的，特别是从近期召开的TCT大会得到的，那就是我们需要长期的数据。1年或2年的随访数据还不够。我们需要观察3年、4年和5年的DES数据，以便确定随访时间是否足够长。从疗效的角度看，我们总是在观察管腔晚期丢失，因为它将告诉我们DES是否在起作用。我们现在很清楚地知道，所有西罗莫司洗脱支架平台的晚期丢失在0.1mm ~ 0.2mm，而紫杉醇洗脱支架的晚期丢失范围在0.3mm ~ 0.4mm。

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