[CIT2008]易损斑块进展与药物洗脱支架安全性——美国心血管研究基金会医学部主席Gary S. Mintz教授专访
《国际循环》:请您谈谈检测易损伤斑块的近期进展。《国际循环》:非常感谢。您如何评价DES的安全性?《国际循环》:今天,很多很多人接受了PCI治疗,您认为PCI治疗的未来如何?
< International Circulation >: Could you talk about recent progress for detection of vulnerable plaques?
《国际循环》:请您谈谈检测易损伤斑块的近期进展。
Prof. Gary S. Mintz: There has not been a lot of progress for detection of vulnerable plaques, but, there are many techniques that are being developed. In the last year, maybe the techniques have got a little better, but there have been a few more studies that have to be done.
Probably the single most important study is PROSPECT in Rome. We have completed the baseline analysis in PROSPECT, and I believe we have reached to the endpoint in terms of 100 events in patients for PROSPECT. So at least we have a group of 700 patients who may have data to be analyzed, which probably will tell us several things. First of all, it will tell us how common are the vulnerable plaques related to events in patients after PCI, that is something we still do not know. Secondly,it will show how often those events are either true vulnerable plaque events or often lesions that should have been treated during the initial PCI. And thirdly it will allow us to look at true technology, especially virtual histology and palpography, to see either technology can predict the vulnerable plaque event.
The other technologies have incremental steps in terms of validation, optical coherence tomography which can provide basic imaging will quickly give way in the next year to the next generation optical imaging, called OFDI, which will be much more user-friendly, but there is no real additional data on that technique involved plaque. Other techniques, such as magnetic resonance imaging, have completely additional validation studies, but, these are not clinical studies. Hence we have made small incremental progress, but we certainly not have made a lot progress in the last year.
Prof. Gary S. Mintz: 很遗憾地告诉你,我必须要指明目前没有很多进展,的确,有很多技术正在研制中。去年,这些技术可能获得了一些进展,但是还不能称之为突破,还需要进行很多研究和试验,这一切都还不十分确定。或许作为重要的研究是在罗马进行的PROSPECT试验,我们已经初步完成了PROSPECT试验的初期分析,已经完成了PROSPECT试验涉及的100例事件,所以,我们至少拥有700例患者的数据,将这些数据进行分析,会告诉我们几件事情:第一,会告诉我们PCI术后患者发生事件与易损伤斑块的相关程度,这一点我们目前一直不十分清楚;第二,会告诉我们这些事件是真实的易损伤斑块事件,抑或是在一期PCI中应当治疗的病变。第三,它会让我们看到最新的科技,特别是虚拟组织学以及血管内超声成像,以及哪项检查可以预测斑块事件。其他技术的进步体现在成像方面,可提供成像功能的光学相干断层扫描分析明年就可以应用在下一代光学成像系统中,称之为OFDI系统(optical frequency-domain imaging),其界面更加友好,并且无需更多有关斑块的数据。其他技术,如核磁成像系统,已经完成了附加成像研究。但仅仅是成像研究,还不是临床研究阶段。所以我们只是取得了小部分进展,坦率的来讲,我们在去年并没有取得显著进步。
< International Circulation >: How do you evaluate the safety of the DES?
《国际循环》:非常感谢。您如何评价DES的安全性?
Prof. Gary S. Mintz: Let’s go over the history. Everybody was very enthusiastic about drug eluting stents until roughly two years ago, when report from the European Society Cardiology suggested that drug eluting stents were associated with more mortality. It turns out that, first of all, those studies were in fact incorrect. The data was presented prematurely and incompletely analyzed. And approximately one year later in TCT in last October, study after study showed that drug eluting stents were at least as safe as, or perhaps safer than bare metal stents.
What we do recognize is the following: That for drug eluting stent, there is a very small but increased risk in very late thrombosis beyond the year, is not seen in bare metal stents. However, what people have to understand is that when bare metal stents have restenosis, and patients come to hospital for additional procedures to treat restenosis, each of those procedures is also associated with a small risk, including the risk of death. So the two issues balance each other. Drug eluting stents have a slight, fairly small increase risk of very late thrombosis, while bare metal stents are requiring multiple repeated procedures overtime, also have an increase risk of complications because of all those additional management procedures.
What we do know about drug eluting stents is that they also required anti-platelet therapy for one year or even longer in some cases to prevent the risk of complications, such as very late thrombosis related to the complexity of lesions. If the patients can’t take anti-platelet therapy, they should not have drug eluting stents, say, a patient who needs a cancer surgery in the next few months, because clopidogrel has to be stopped.
Prof. Gary S. Mintz: 首先让我们回顾一下历史。大约2年前,每个人都对药物洗脱支架非常热忱,直到欧洲心血管学会的报告提示药物洗脱支架可能导致死亡率上升。但后来证实这些研究都是不正确的。研究数据被提前发表,并且分析不充分,后来大约1年后,也就是去年10月在TCT上,一个接着一个的研究证明药物洗脱支架安全或至少比裸金属支架安全。因此,我们必须认可以下事实:对于药物洗脱支架,的确存在晚期血栓形成的风险增加情况,且在裸金属支架中并未观察到。我们认可这些事实。不过,人们也要注意到当金属支架发横狭窄时,患者到医院来进行后继治疗来治疗狭窄,这些操作的每一项均与风险相关,包括死亡的风险。所以这两件事情实际上互相平衡。药物洗脱支架可导致晚期血栓形成发生率轻度升高,但是裸金属支架,反过来需要多次操作,同样会导致并发症风险升高,因此这两种情况达到了互相平衡。另外,我们知道药物洗脱支架同样需要抗血小板治疗1年,有些患者甚至需要更长的时间,并发症的风险,比如与病变复杂程度有关的非常晚期血栓形成,并且如果患者没有应用最佳的抗血小板治疗,他们不该应用药物洗脱支架。比如,有一个患者在接下来的几个月中可能接受癌症手术。这时患者不应该应用药物洗脱支架,因为氯吡格雷不得不停药。如果病变十分复杂,可能还需要超过12个月的氯吡格雷。
< International Circulation >: Today, numerous people received PCI, what do you think of the future of PCI?
《国际循环》:今天,很多很多人接受了PCI治疗,您认为PCI治疗的未来如何?
Prof. Gary S. Mintz: As long as the coronary heart diseases exist, the PCI therapy will come to stay, and will become moreand more the preferential treatment of patients. But patients still require aggressive medical therapy because they have to understand the PCI does not make the disease vanish, but remit the tight blocking of blood supply. It relieves the symptoms rather than the ischemia, so if people have coronary disease, they need the PCI as well as the medical therapy.
Prof. Gary S. Mintz: 我想只要存在冠心病,PCI治疗就会一直存在,并且会称为越来越多患者的首选治疗。但是患者仍需要积极的内科药物治疗;人们需要知道PCI并没有将疾病消退,它只是将血供紧张情况暂时缓解。我们只是缓解了症状,并没有缓解缺血。如果你的患者患有冠心病,采用PCI后,内科药物治疗当然也不能少。
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