Patrick W.Serruys教授 CIT联合主席、荷兰Erasmus大学
<International Circulation> : When comparing with first generation DES what do these bioabsorbable scaffolds have to offer in terms of anti-platelet therapy?
《国际循环》:比较第一代药物洗脱支架(DES),在置入这些生物可吸收支架后,如何进行抗血小板治疗?
Prof. Patrick: Lets see what is antiplatelet therapy. Classically it is Clopidogrel and aspirin and in the guideline it is said that you have to use that atleast six months and in acute coronary syndrome, you use it for 12 months. That is the guideline in the United States and Europe so that is what the people do. The novelty is that there are other antiplatelet drugs after Clopidogrel you have Prasugrel and after that you have Ticagrelor so it makes the things a little more complicated in the sense that Prasugrel and Ticagrelor do not have to be metabolized by the body and you are not dependent on genetics. Now, the new DES, I would say that there are two categories. There is the one with durable coating, I am thinking about Resolute with the BioLinkscoating, which is a complex polymer c 19, c 10 etc and then you Xience with the flow polymer. Now the novelty is that these two polymers, at least the two companies claim that their polymer is responsible for a certain passivation of the surface and are less thrombogenic. So far it has not been demonstrated in a randomized trial but it is true that there has been a registry for stents with Xience and as a consequence of that the regulatory body in Europe has authorized only three months of dual antiplatelet therapy. To what extent these people in communities using this principal is a little bit unknown because it is not a strong evidence based medicine, so technically it seems that after three months you could stop the Clopidogrel in these patients receiving Xience or the Resolute although the fact exists that the regulations are only for the Xience so far. In terms of biodegradable, that is much more complex issue in the sense that yes, from a theoretical point of view, when the scaffold has disappeared completely, there is no more foreign body, it is just nature with its own endothelial lining, you should not give dual antiplatelet therapy. Do not forget that what is killing the patient is the arterial thrombosis, 85% of the problem in our brain, our heart, or our legs is artherial thrombosis. So when you are an atherosclerotic patient, you have to receive at least one medication that is antiplatelet and historically it has been aspirin. The question is in the future will the aspirin be replaced by something more powerful, that is what we are testing in certain trials like Global Leaders. Now the bioabsorbable immediately in the first three months, we do not know.
Patrick 教授 :首先要了解什么是抗血小板治疗。美国和欧洲的指南推荐的经典治疗是氯吡格雷联合阿司匹林,使用至少6个月,急性冠脉综合征患者则应使用12个月。目前有一些新的治疗药物,继氯吡格雷后出现了普拉格雷,之后又有替卡格雷。有意思的是,普拉格雷和替卡格雷不经机体代谢激活且其有效性不受基因多态性的影响。当前存在两种新型的DES支架,其中一种拥有永久性涂层,我指的佐他莫司支架,这种支架拥有包含了可聚合物c 19和c 10的BioLinks涂层,你可能会觉得是依维莫司洗脱支架。但对于这两种支架,目前至少2家公司宣称,聚合物造成了支架表明的钝化以及少量血栓形成。迄今,尚无随机试验针对这两种支架的抗血小板治疗进行研究,事实上仅在欧洲有针对依维莫司的注册研究,并据此建立了监管体系,批准了为期3个月的双联抗血小板治疗。对于置入了这两种支架的患者应接受何种程度的抗血小板治疗,我们尚未完全明确,因为还缺乏基于药物试验的强有力证据。从技术上说,可以在置入上述两种支架后三周停用氯吡格雷,但事实是,目前为止,仅依维莫司支架患者可接受这一方案。而生物可降解支架则面临着更多的问题。理论上,在生物支架降解完全后,血管内已无任何外来物体,仅有正常存在的内皮层,此时也不应继续给予抗血小板治疗了。但别忘了,此时患者血管内已经出现了动脉血栓形成。大脑、心脏和下肢85%的血栓为动脉血栓。动脉血栓患者至少应服用一种抗血小板药物,一直以来是采用阿司匹林治疗。问题是未来阿司匹林将被某种新型药物所取代,Global Leaders试验正在进行这方面的研究。目前,我们对生物可吸收支架的研究刚开始3个月,一切仍未可知。
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