<International Circulation>: At this years meeting the TRILOGY trial ahs been presented and you gave a discussion at that presentation.  Can you give us a brief summary of this trial and what do you think is the stress of this trial?
　Prof.  De Caterina: This trial addressed the issue of intensified antiplatelet therapy with aspirin plus prasugrel， compared to aspirin plus clopidogrel， in a population of medically treated， non-ST-elevated acute coronary patients.  Now， why was a trial like this needed?  It was needed because the previous trial with prasugrel in acute coronary syndromes was limited to a population of invasively treated patients， which is not the standard treatment for acute coronary syndromes.  It has been roughly calculated that， even in western societies， about half the patients with the acute coronary syndromes do not receive invasive treatment for a variety of reasons.  Some of the reasons are dictated by the organization of the health care system but some are related to the complexity of the patient: elderly patients with comorbidities are more complex. As a matter of fact， the population of medically treated， acute coronary syndrome patients is at a higher risk than those invasively treated. This has been shown in several reports. (2:19) In addition， a higher mortality and risk of ischemic events， this population also has a high bleeding incidence. It is important to see if anything in terms of antiplatelet potency can improve prognosis in this population.  The study was run in over 9，000 patients， all purely non-ST-elevation acute coronary syndrome， and were randomized 1 to 1 to either clopidogrel or prasugrel. This was an event driven trial， powered to have enough events to detect 22% relative risk reduction in the primary endpoint of death， myocardial infarction， or stroke.  This endpoint is very relevant because it is a very solid and does not include hospitalization or softer endpoints and the magnitude of the reduction anticipated to prove the superiority of prasugrel was thought to be， make likely is， clinically relevant. This was therefore a strongly needed trial.  Another reason for running such a trial was to tailor the therapy with prasugrel in persons over 75 years of age， because already in TRITON there was an adjustment with the lower dose in patients less than 60kg of bodyweight， but the elderly population experienced a devastating excess of stroke. By the way this is possibly of even more relevance to the Asian population， which may have an increased risk of hemorrhagic stroke.  There was a need to see whether you could adjust the dose of prasugrel in order to see whether or not the 5mg daily regiment was preserving efficacy while improving the safety of these populations.  These were the two aims of the study， to assess whether there was a more effective and reasonably safe effect of the intensified antiplatelet treatment in this population and whether the reduction of the dose of prasugrel in persons over 75 was appropriate.
《国际循环》：今年的会议上公布了TRILOGY的结果并且您对此进行了讨论。您能简单地概括一下这个试验吗？您认为这项试验面临的最大困难是什么？
De Caterina教授：这项试验旨在比较阿司匹林加普拉格雷和阿司匹林和氯吡格雷在ST段抬高的急性冠脉综合征患者中强化抗血小板方面的作用。目前我们是非常需要这方面的试验的。因为以前的普拉格雷在急性冠脉综合征患者中的试验仅限于侵入性治疗的人群，而不是大部分急性冠脉综合征患者的标准治疗。实际上粗略估计，在西方国家有一半的急性冠脉综合征患者因为各种原因没有接受侵入性治疗。一些原因是收到了健康系统组织的限制，而另一些是因为与患者病变的复杂性相关，比如患者年龄较大，存在一些并存病，因此进行药物治疗的人群风险要比进行侵入性治疗的人群要高的多，这在既往的一些研究中已经进行了报道。除了有更高的死亡率和更高的缺血事件的风险，这些患者出血的发生率也更高，因此非常有必要明确在这类人群中是否有能改善预后的抗血小板药物治疗方法。这项试验的研究对象是超过9，000例ST段抬高的急性冠脉综合征患者，患者被1比1随机分为氯吡格雷或普拉格雷组，是一项事件驱动的试验，要求在首要终点有足够的事件，包括死亡、急性心肌梗塞、中风，检测到的相对风险下降22%。这个终点是非常相关的，因为非常硬性的终点并不包括住院率或软性终点，因此它是一个终点真正重要的试验，并且其预期来证明普拉格雷优越性的幅度被认为是临床相关的，所以这是一个强烈需要的试验。这一试验重要性的另一原因是将普拉格雷的治疗适用于大于75岁的老年人，因为在TRITON试验中对于体重低于60公斤的人给予了药物剂量的调整，他们使用的药物剂量更低，但是老年人群发生中风的风险是显著增加的，而且这与亚洲人群的相关性更大，因为亚洲人群发生出血性中风的可能性更高。因此需要明确医生是否需要调整普拉格雷的用量以确保每日5毫克的剂量能在有效抗血小板的同时还能减少老年人群出血的风险。总的来说此项试验的目的有两个，一个是评估在研究人群中强化抗血小板治疗是否更有效和具有合理的安全性，另一个是对于年龄大于75岁的老年人是否应该降低药物的使用剂量。