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[ESC2012] 药物治疗ACS患者需要TRILOGY试验——Raffaele De Caterina教授专访

作者:  R.DeCaterina   日期:2012/9/20 18:05:11

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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。


<International Circulation>: What is your opinion about the duration of intensive antiplatelet therapy in ACS patients?  Would it be the longer the better?
Prof.  De Caterina: That is still unclear.  It is unclear for a variety of reasons including the fact that we now have different options for treating the patients.  First of all, I want to say that bleeding events where numerically higher  in the prasugrel group than in the clopidogrel group, which speaks to the efficacy of the treatment from the stance of platelet function inhibition.  This is because in hemostasis there is no such thing as a “free lunch”: whatever one gains in terms of efficacy, one loses in terms of safety. The problem is the find the good compromise, the “sweet spot”.  We have this increase in bleeding, not major bleeding; numerically higher, but not significantly statistically higher. Yet there was some bleeding, so what would you do with these late efficacy findings?  Would you submit the patient to a prolonged therapy with a drug that is already expensive, in addition to clopidogrel that is now very cheap?  Would you give him or her some almost certain excess risk of bleeding for a late effect that still is not statistically demonstrated as significant? If you take all bleeding that is increased for a safety effect, it may be the case that there is a net clinical benefit, but we cannot be totally sure that this is a possibility and this concern remains for other therapies. This is also the case for adding an anticoagulant in patients as in the ATLAS 2 study in which there was, at least, a stronger efficacy signal, though also in spite of an important safety signal in terms of increased bleeding.  In this case, even if you have an apparent reduction of mortality, people are concerned about giving a more potent drug or an additional drug for prolonged periods of time. At the current status of the situation, I would not give a prolonged therapy to these patients.
《国际循环》:您认为ACS患者的强化抗血小板治疗应该持续多长时间?是不是越久越好呢?
De Caterina教授:这个问题至今还不清楚。它不清楚的原因是多方面的,包括目前我们对患者治疗的选择存在不同选择这一事实。首先我想说的是普拉格雷组发生出血的患者数目比氯吡格雷组多,这代表了预防支架内血小板聚集功能作用的有效性,因为在平衡这一问题上从来没有“免费的午餐”,不管何时有效性的增加都会减少安全性,因此问题在于找到最折中的方案,一个最合适的平衡点。因此我们发现出血的风险增加了,但是并不是大出血,确实从数字上来看出血的发生更多,但是并非统计学上的差异更显著,可是确实是有出现增加,那么我们该如何处理这一晚期有效的结果呢?你会给患者更长时间使用这种目前来说还是很贵的药物,而不是使用现在已经很便宜了的氯吡格雷吗?让患者处于几乎肯定增加的出血风险之下,你可以认为所有的出血依然是安全有效的,但是我们不能完全肯定这是一种可能,并且这种顾虑也存在于其他一些治疗中,比如为患者增加一种抗凝药物,这也是ATLAS2试验中的情况,在那个试验中起码有更有效的信号并且无论如何也有以出血增加为标准的重要的安全信号。在这样的情况下,即使试验能明显的降低死亡率,人们还是会想使用更有效的药物或者添加一种药物治疗更长的时间。如果我遇到目前的这种情况,我不会给这些患者使用更长时间的治疗。

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