International Circulation: Last November, you published an article entitled “Randomized, Double-Blind, Multicenter Study of the Polymer-Based 17-Beta Estradiol-Eluting Stent for Treatment of Native Coronary Lesions: Six-Month Results of the ETHOS I Trial” in Catheter Cardiovascular Intervention. You found that the 17-beta estradiol-eluting R stent was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. What is your opinion about these results?
International Circulation: Last November, you published an article entitled “Randomized, Double-Blind, Multicenter Study of the Polymer-Based 17-Beta Estradiol-Eluting Stent for Treatment of Native Coronary Lesions: Six-Month Results of the ETHOS I Trial” in Catheter Cardiovascular Intervention. You found that the 17-beta estradiol-eluting R stent was well-tolerated, but showed no benefit for treatment of coronary lesions when compared to controls. What is your opinion about these results?
《国际循环》:去年十一月,您在《导管心血管介入杂志》发表了题为“多聚17-β雌二醇洗脱支架治疗原位冠状动脉病变的随机、双盲、多中心试验:6个月 ETHOS I期试验结果”的文章,发现17-β雌二醇R洗脱支架有很好的耐受性,和对照组相比治疗冠状动脉病变没有更多益处,您对这些结果有何看法?
Professor Abizaid: This is one of the trials that we conducted to find alternatives to increase the safety of drug-eluting stents. This is in the context of the recent published data on late stent thrombosis. Of course, there will be no discussion or debate regarding the efficacy of drug-eluting stents, but I think it is very important to do more research to find better solutions for the safety of these devices. Therefore, this is one of the trials that we conducted in Sao Paolo and in Germany. This was a multi-center trial testing the beta estradiol-eluting stent. This is eluted from a durable polymer. What we learned is that there were no issues regarding safety. We had the typical MACE, acute MI, and target lesion revascularization that we see with bare metal stents, for instance. Despite the safety profile, this was a negative study because it didn’t show any improvement in efficacy. That’s why research like that is very important to help us decide what will be the next step, and this was certainly not one of them because of the lack of efficacy.
Abizaid教授:这是在最近发表的晚期支架内血栓形成数据的背景下,我们寻找增加药物洗脱支架(DES)安全性的替代物所进行的试验之一。当然对于DES的有效性没有讨论和争议,但我认为进行更多研究以寻找更好解决此类支架安全性的方法是非常重要的。因此我们在巴西圣保罗和德国实施此试验。这是一项检验β雌二醇洗脱支架的多中心试验,该支架经永久多聚物洗脱。通过试验我们得知该支架没有安全性问题,其和裸金属支架一样有典型的主要不良心脏事件(MACE)如急性心肌梗死(MI)和靶病变血运重建(TVR)。除安全性问题外,由于治疗效果无任何改善,这是项阴性试验。这类研究非常重要,因其可帮助我们决定下一步的方向,由于缺乏有效性的数据,未来会有更多的研究。
International Circulation: Really it’s a matter of safety or efficacy alone isn’t enough; you need both.
《国际循环》:看来只有安全性和有效性的不够的,两者您都需要。
Professor Abizaid: Exactly, you need to combine both.
Abizaid教授:确实如此,需要将两者结合起来。
International Circulation: Do you think the rate of late-acquired incomplete stent apposition after drug-eluting stents is the same for patients with implantation of sirolimus or paclitaxel-eluting stents?
《国际循环》:您认为置入西罗莫司或紫杉醇支架后,晚期获得支架贴壁不良的发生率一样吗?
Professor Abizaid: I truly believe that there isn’t a significant difference between those two devices, mainly when you are talking about Cypher and taxus. In our personal experience in Sao Paolo, being the first ones to implant these devices almost 10 years ago, we keep following these patients very closely and when we do intravascular ultrasound and angiography at late time points, what we learn is that the incidence is rare and when it happens I don’t see any difference between these two devices. Of course, there will be some other limus drugs coming in, and for instance, what we learned so far, with Endeavor?, which is a limus drug with a (PC) phosphorylcholine, we don’t see late-acquired late incomplete apposition as often as we see with the first generation of drug-eluting stents.
Abizaid教授:我认为Cypher和TAXUS支架间没有显著差异。根据我们在圣保罗的经验,密切随访那些最初置入这些支架、目前已接近10年的患者,在最近的时间点对其行血管内超声(IVUS)和血管造影检查,其发生率非常低,并且即使出现两者间也无任何差异。当然,会有其他limus类药物混入其中,例如, 在应用磷脂酰胆碱的Endeavor支架,我们没有发现在第一代DES常见的晚期获得支架贴壁不良。
International Circulation: So you have seen a bit of an improvement from the first generation of drug-eluting stents?
《国际循环》:因此您发现一些优于第一代DES的改进?
Professor Abizaid: With more anecdotal cases, and we are building more of a body of evidence, but this is my impression.
Abizaid教授:根据很多无对照的病例,我们积累了大量的证据,但这只是我的初步印象。
International Circulation: Can you give us some advice on how to treat patients with late incomplete stent apposition after implantation of a drug-eluting stent?
《国际循环》:对于置入DES患者出现的晚期获得支架贴壁不良,您有何处理建议?
Professor Abizaid: I think this is a good question and we always debate what to do when we have a case like that. Of course, when a patient has progressed disease in other vessels or even distal or proximal to this vessel, and mainly if there is any left main or multi-vessel disease, we are trained to send those patients to surgery. However, when the patient is doing well, and it’s just an IVUS finding, what we do now is to keep the patient on Plavix and aspirin for their lifetime when we have a finding like this one. It’s not worth it to go back with a balloon and dilate more. How much can you go? You can go up to 5, 6, or 7mm in terms of balloon size, and then you are going to cause more injury. So I think there is a consensus that we just give prolonged antiplatelet therapy.
Abizaid教授:这是一个很好的问题,当出现这样的问题时我们经常争论。当患者的其他血管或此血管的近端或远端已经出现进展性病变,并且主要是左主干或多支血管病变时,我们往往将患者送往外科治疗。然而当症状改善,并且只是从血管内超声发现,我们现在做的是让患者终生服用氯吡格雷和阿司匹林,而不值得再行球囊扩张。将球囊直径扩张至5、6或7mm,会造成更多损伤,因此我们一致认为只给予延长血小板治疗。
International Circulation: I have a question regarding the approach with bifurcation lesions. In Brazil, what is your experience and the approach in treating bifurcation lesions?
《国际循环》:您在巴西治疗分叉病变的经验和方法是什么?
Professor Abizaid: It depends a lot, I have to say. When you have a true bifurcation lesion with a lot of disease going into the side branch, it is a large vessel with more than 3mm lesion extending into the side branch, then the trend is to deploy a second stent and go with a two stent approach. But, I have to say that in most of the cases that we only see a little bit of disease in the side branch, the most common technique is to pre-dilate both branches and just to deploy a stent in the main branch, what we call a provisional stent.
Abizaid教授:我不得不说这需要依据很多方面。当大血管分叉处病变进展到侧支血管超过3mm时,目前趋势是应用双支架置入技术放置第二枚支架。但大多数病例的侧支血管只有很小的病变,最常用的方法是先扩张主干和分支,并只在主干放置支架,即所谓必要性(provisional)支架。
International Circulation: In January, you published an article entitled “Intravascular Ultrasound Assessment of the Novel AngioSculpt Scoring Balloon Catheter for t