<International Circulation>: So you mentioned there were some reconfiguration you had to do in terms of the study work.  What was this?
《国际循环》：你提到试验需要某些重组工作。是指什么？
　Dr. Roe: You know many sites， especially in the United States，  have focused on ACS patients in the cath lab， so they identify patients based on the cath lab. That strategy would not work in TRILOGY by itself， so we actually sent educators to the sites to work with the study coordinators and physicians to broaden their approach to find medically managed patients both inside and outside the cath lab. That was a change because they had to be a little more aggressive with broader thinking. When they started identifying patients， it was really magical.  I visited many of these sites in the United States and it was interesting to see the change in focus. I think this will help for other studies， as now the focus will not just be on cath lab patients. This was good for TRILOGY because we found these patients， they exist and we were able to enroll them in these studies.
MT Roe博士：你知道很多中心，尤其是在美国针对的是导管室里的ACS患者，因此他们入选的是导管室的患者。但是，在开展TRILOGY试验时采用这样的方法行不通。因此，实际上我们派了些教育人员去一些中心，与研究协调员和医生一起工作，增加他们在导管室内和导管室外入选更多单纯药物治疗患者的方法。这是一种改变，因为他们需要更积极、广泛地思考。当他们开始找到更多患者时，确实很神奇。我走访了美国的很多中心，看到一些主要的变化很有趣。我认为，此种做法对其他研究也有帮助，因为现在的重点不仅仅是放在导管室患者身上。此种做法对TRILOGY试验是有好处的，因为我们发现确实有这样的患者，也能把他们入选到研究中来。
　International Circulation: And now they are all registered and their results are available?
《国际循环》：患者被入选研究，我们也得到了结果？
Dr. Roe: Yes.
　MT Roe博士：是的。
<International Circulation>: So the trial showed no difference in primary endpoints between cardiovascular death and myocardial infarction and stroke between prasugrel and clopidogrel， but was there a trend that favored prasugrel over a one year treatment and what is the clinical significance?
《国际循环》：试验未发现普拉格雷和氯吡格雷组的心血管死亡、心梗和卒中的主要终点存在显著差异，但是有1年时普拉格雷有优于氯吡格雷的优势，这一发现的临床意义是什么？
Dr. Roe: We interpret that with the knowledge that the primary endpoint was not met. However， we picked up on this because no one has studied therapy for such a long period of time. The medically managed patients we studied may not respond early on as a patient who has been revascularized. We discussed this in the paper in the New England Journal and had a few references， but with time， it looked like they did consistently across all the components of the primary endpoint and it appeared to be magnified with time. Were the patients with long term follow up different from the younger patients? or patients with shorter follow up? or was there some artifact of how we conducted the trial? This was not the case and the patients are the same， so we think this is a real finding.  It was extenuated when we count for all the recurring ischemic events and the separate analyses we did. It raises the question: should we continue the trial for another four or five years?  We did not know this until we got to the database， so there was no way we could have thought about it. It may be that in the medically managed patient in a long term study with long term treatment， may see benefit. However， you would have to do another study to verify.
MT Roe博士：我们的解读是没有达到主要终点。但是，既往没有研究在这一患者群观察了这么长时间。单纯药物治疗的患者可能不如血运重建的患者那么早对治疗有反应。我们在《新英格兰医学杂志》中发表的文章中探讨了这一问题，有几篇参考文献。随着时间的推移，这一趋势在主要终点的各个组成部分上都有所体现，而且越来越明显。随访时间长的患者与年轻患者或随访时间短的患者相比是否有所不同？或者试验当中有一些假象出现？但实际上并非如此。患者是一样的，因此我们认为是真实的发现。当分析所有的复发缺血事件和单独分析时，两组的区别减弱。这就提出了一个问题：是否应当把试验时间延长，再观察4 ~ 5年？未分析数据时，我们没法想到这一点。单纯药物治疗的患者治疗时间更长、随访时间更长的话，可能会看到益处。但是，必需得开展另一项研究来证实TRILOGY的结果。