<International Circulation>: I’m here with Professor Antonio Colombo and also Professor Li Weimin. First of all I’d like to thank Dr. Colombo and Dr. Li for accepting the interview today with International Circulation; it’s our pleasure to interview you today.
The first question I have for you， doctor， is a short while ago you published you published an article entitled: ‘A randomized trial comparing eptifibatide vs. placebo in patients with diffuse coronary artery disease undergoing drug-eluting stent implantation’.
What is the design of this trial， and， what are the characteristics of the patients? Also， what is the result from this trial?
《国际循环》：今天来到这的是Antonio Colombo教授和李为民教授。首先，我想感谢二位能够接受国际循环的采访。非常荣幸。第一个问题：不久前您发表了一篇文章，题为“药物洗脱支架术后冠脉弥漫性病变的患者使用埃替非巴肽vs安慰剂的随机对照研究”。 该研究设计如何？入选患者是何特征？预期结果如何？
Prof. Colombo: What you alluded to was the preliminary study of the feasibility to give a IIb/IIIa inhibitor， in particular eptifibatide in patients undergoing multiple stent implantation.. We all know that the risk of CK-MB elevation following implantation of several stents in long segments of the coronary arteries is higher. If we measure the incidence of non -Q wave MI by 3 times the CK-MB rise， we can go up to 15% incidence when you implant long and several stents. So I think there is a need to see what we can do to lower these risks.
For that specific reason we launched the INSTANT trial. This is a multi-centric study which will randomize several hundred patients to one strategy which is eptifibatide during implantation of long stents， versus placebo. The primary end-point of this study would be periprocedural myocardial infarction. We hope that with these strategies we should be able to lower the incidents of periprocedural myocardial infarction， most probably down to 10%， or less， which is already an achievement. Of course there are various factors involved， not only platelet mediated， but distal embolization which is made of atherosclerotic material and maybe not affected by IIb/IIIa. But some components are certainly mediated by platelet activation. So， we think that the administration of these potent IIb/IIIa inhibitors are worth it in this field.
Colombo教授：您所指的是，初步研究的可行性（初衷），对多个支架置入的患者给予糖蛋白IIb/IIIa受体抑制剂——尤其是埃替非巴肽。众所周知，在给大段冠脉置入若干支架后CK-MB增高的风险很大。如果以CK-MB增高3倍为标准计算非Q波心肌梗死的发生率，它的发生率可达到15%，在置入若干长支架后。所以，有必要去研究如何减少这些风险。
正因为这个特殊原因，我们发起了INSTANT 试验。这是一个多中心临床研究，它将几百个置入长支架的患者随机分为埃替非巴肽组和安慰剂组。试验的主要终点事件是围手术期心肌梗死。我们希望通过这些措施，可以降低围手术期心肌梗死发生率，并且很有可能降至10%或不到，至少目前的实验结果已经证实这个结果。当然这受很多因素影响，不仅仅是调节血小板的问题，也包括动脉粥样硬化斑块物质组成的远端血栓，而且这种斑块可能不受糖蛋白IIb/IIIa受体的影响。但是其中的一些成分确实是受到血小板激活的调节。因此，我们认为在这个方面，使用这些糖蛋白IIb/IIIa受体抑制剂很有价值。
Prof. Li Weimin: Just now you mentioned this clinical trial. Of course I know your primary end point and your lastest result from this trial. So we will look for the latest result. As one of the most famous cardiologist， you might have more experience in many fields. Would you like to share your experience about stents implantation for bifurcation lesion. Of course I know you introduced Crush technique to the world， so I would like to know if you have some recent evidence about this procedure?
李为民教授：刚刚您提到这个临床试验。当然，我知道您试验的主要终点和最近结果。所以，我们将关注最新结果。作为最著名的心脏病学专家之一，您可能有很多经验在诸多领域。您愿意分享一下冠脉分叉病变支架置入的经验吗？当然，我知道您给世界带来了Crush技术，那么关于这项术式您有最新的研究证据吗？
Prof. Colombo: The most recent evidence came from the CACTUS study. The CACTUS study was presented at the EuroPCR in Barcelona before the summer. This was a randomized study of over 350 patients， with a true bifurcation: which means disease in the main branch and the side branch. They underwent randomization to two stents implanted with a crush technique compared to randomization to one stent with cross-over to two stents when the result was not sufficient. The end points of the study were measured in myocardial infarction deaths and restenosis. But the main end point was just angiographic restenosis on the main branch and the side branch . The findings of this multi-centric study conducted in Italy and Germany were very interesting. First of all， the immediate result was a little better from the angiographic point of view with the two stents， as expected. The incidence of periprocedural complications were similar， no difference. The incidence of six months thrombosis – which is a very important safety end point – was equal; there were three thrombosis in one group and two in the other group， so fairly equal. The incidence restenosis was not significantly different， which means that you can implant one stent most of the time， and implant a second stent only if you need it. The restenosis on the main branch was， as expected， around 5%， a single digit. The restenosis on the side branch was between 10% and 15%， which is a little bit higher but still acceptable. And the same number was with two stents as intentioned to treat versus one stent. What is important to note is that with these results were obtained with a 30% cross over from one stent to two stents. This means that in one patient out of three， you needed to implant two stents. So， the lesson from the study is: if you need to implant two stents， there is no problem， you can do that. There is no additional risk. Most of the time you can get away with one stent， but very frequently – one in three， and maybe with more advanced disease one out of two – you need two stents. So， you need to learn how to do both， because some lesions need one， some other lesions needs another. Whatever you do， if you have done it properly it is not going to carry a particular risk for your patient.
Colombo教授：来自CACTUS的最新研究证据。今夏之前，CACTUS研究在EuroPCR公布。这个随机对照研究收集了350多有真性冠状动脉分叉病变的患者，它指主干及分支血管开口存在＞50%的狭窄。试验将患者随机分为两组，试验组用crush技术实施双支架置入，而对照组则是：置入一枚支架，当（再通）结果不充分时交叉到置入双支架的试验组。研究终点是观察再狭窄和致死性心肌梗死这两个终点事件的发生率。但是主要终点只是冠脉造影探究主干和侧支再狭窄。我们发现这个多中心研究在意大利和德国的实施非常有趣。首先，从血管造影方面显示与预期的一样——使用两个支架的即刻结果稍好于单个支架。而围手术期的并发症两者并没有显著差异。6个月血栓形成的发生率是一个非常重要的安全终点——两者也是基本一样（一组有3例血栓形成而另一组有2例）。再狭窄发生率没有显著的差异，这表明在大多数情况你可以选择采用一个支架置入，只有当有必要置入第二个支架的时候再置入第二个。与预期的一样，主干的再狭窄率大约为5%，是个位数。而侧支的再狭窄发生率在10%~15%之间，这个发生率要稍高于主干的再狭窄率，但是仍然能够接受。出于与单个支架进行对比的意图，有相同数量的患者接受两个支架置入。值得我们注意的是，这一结果来自30%患者交叉到双支架组的情况下。这意味着3个患者中就有1个患者需<