《国际循环》:感谢你接受访谈,主要想问有关TRILOGY-ACS试验的问题。明天将公布TRILOGY-ACS试验的结果。我们都知道,虽然ESC指南推荐ACS患者无论院内治疗策略如何都应当接受双联抗血小板治疗,但是当前非血运重建ACS患者应用双联抗血小板治疗的比例还相当低。TRILOGY-ACS试验针对的是单纯药物治疗的ACS患者,你认为该试验的临床意义是什么?
Gilles Montalesco 法国巴黎皮提亚大学医院
<International Circulation>: Thank you Professor Montalesco for accepting this interview from Munich at ESC 2012. This interview will mainly focus on the TRILOGY trial. It will be presented tomorrow but today I want to first ask you: We know that despite the ESC recommendation to use dual antiplatelet therapy in ACS patients regardless of their in-hospital treatment strategy, it is still very much underused in medically treated ACS patients. What is the clinical significance of the TRILOGY trial which was carried out in medically treated in patients with non-ST segment elevation with acute coronary syndrome (NSTE-ACS)?
Prof. Montalesco: It is an important trial because the previous study, TRITON, was performed only in PCI patients. Patients were randomized when there was indication for PCI and stenting. In this situation. prasugrel was superior to clopidogrel with less deaths, MI, and stroke, with a slight excess of bleeding. However, the patients here were not treated while they were in the CCU waiting to go to the cath lab. This is different from PLATO, which studied the drug ticagrelor and where patients were randomized in the CCU before going to the lab. There were all types of patients, and of course some got PCI and stents and others were medically treated. For these patients, they received a wide indication with ticagrelor while indications for prasugrel increased because of the randomization at the time of PCI. The question remains: Should we treat a patient with prasugrel, rather than clopidogrel, when they deserve only medical treatment? Should it be given before or after an angioplasty? Two trials have been set up. One is TRILOGY, which is mainly for the patient with no indications for an angioplasty. It is pure medical treatment with elderly patients. The other trial is called ACCOAST, which is still ongoing and is looking at pre-treatment, before going to the lab, with either prasugrel or a placebo for the period before the angioplasty. The ACCOAST trial will be presented next year in Amsterdam, but this year we will have TRILOGY. TRILOGY is clearly important, and it is a big challenge because we know that thienopyridines are very good in stented patients. In medically treated patients it is less obvious, as was true also for clopidogrel, so we awaiting the results.
《国际循环》:感谢你接受访谈,主要想问有关TRILOGY-ACS试验的问题。明天将公布TRILOGY-ACS试验的结果。我们都知道,虽然ESC指南推荐ACS患者无论院内治疗策略如何都应当接受双联抗血小板治疗,但是当前非血运重建ACS患者应用双联抗血小板治疗的比例还相当低。TRILOGY-ACS试验针对的是单纯药物治疗的ACS患者,你认为该试验的临床意义是什么?
Montalesco教授:我认为TRIOLOGY试验是一项重要的试验,之前的TRITON TIMI-38试验只是针对PCI患者,随机化有PCI和支架指征的患者。TRITON TIMI-38试验显示普拉格雷较氯吡格雷显著减少死亡、心梗和卒中,轻度增加出血风险。但是,患者在心脏监护病房等待进入导管室时并未接受治疗。而PLATO试验的情况有所不同,该试验研究了替格雷洛,患者在进入导管室之前在心脏监护病房即被随机化接受治疗。PLATO试验纳入的患者既有接受PCI的患者,也有只接受药物治疗的患者,因此,替格瑞洛获得了广泛的适应证。因为在PCI时的随机化,普拉格雷的适应证现在有所增加。问题是,对于只能接受药物治疗的ACS患者,是不是应当给予普拉格雷而不是氯吡格雷?是在造影前还是后?有两项试验旨在回答这一问题。一项是TRILOGY-ACS研究,针对无冠脉造影指征而单纯进行药物治疗的NSTE-ACS患者,其中包括许多老年患者。另一项研究是正在进行当中的ACCOAST研究,比较在PCI时和在诊断为NSTEMI行PCI之前,普拉格雷或安慰剂的疗效。这项研究将于明年在荷兰阿姆斯特丹年会公布,今年将公布TRILOGY-ACS研究的结果。TRILOGY-ACS研究显然是重要的,这是一个大的挑战,因为我们知道噻吩并吡啶类药物用于支架患者是非常好的,在单纯药物治疗的患者则不那么明显,所以我们等待它的结果公布。
<International Circulation>: So what is your opinion on DAPT in medically treated patients?
Prof. Montalesco: I think we have to be careful, because even if you look at the data from PLATO with ticagrelor, the medically treated patient have only a borderline benefit with ticagrelor: it is not as striking as with PCI patients. The second point is that patients who are medically treated are generally older, are women, and are with more co-morbidities, so the risk of bleeding is much higher. I am waiting for the TRILOGY data, but I would be very careful to increase antiplatelet therapy. So far we have not seen fully convincing evidence for strong DAPT for medical treatment only.
《国际循环》:单纯药物治疗的ACS患者如何进行双联抗血小板治疗,您个人的观点是什么?
Montalesco教授:我认为应当谨慎,因为即使是PLATO研究的数据,我们会发现药物治疗的患者应用替格雷洛的统计学获益微小,并不如PCI患者获益那么明显。另外,单纯药物治疗的患者通常年龄较大、女性所占比例更高且并存疾病更多,因此出血风险更高。我在等待TRIOLOGY-ACS研究的结果,但是对于加强抗血小板治疗我还是持谨慎态度,因为迄今为止在单纯药物治疗的ACS患者还没有应用强的双联抗血小板治疗的完全令人信服的证据。