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[CIT2012]药物洗脱球囊的发展现状及DES置入术后的抗血小板治疗——美国斯克里普斯临床中心介入心脏病学研究所所长Dacid E. kandzari教授访谈

作者:  DacidE.kandzari   日期:2012/3/19 10:23:53

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目前在美国,药物洗脱球囊尚未获得批准用于冠状动脉和外周血管的介入治疗。从更广泛的角度来说,我们必须认识到,药物洗脱球囊最初是在下肢血运重建领域进行研究的,(尽管已经开始)在冠状动脉介入中的应用资料还非常少。

  Dacid E. kandzari, MD.:美国加利福尼亚斯克里普斯临床中心介入心脏病学研究所所长。
  International Circulation: What is the effect of drug-eluting balloons in preventing events in long-term follow-up? Is there a necessity for high-risk patients to use drug-eluting balloons?
  Dr Kandzari: Today in the United States we do not have drug-eluting balloons approved for use in either coronary or peripheral interventions. But more widely speaking, it is important to recognize that drug-eluting balloons have been principally studied for lower extremity revascularization and we have (albeit emerging) still less data for their use in coronary interventions. Plausibly there are a number of opportunities for drug-eluting balloons particularly in high-risk patients – patients with very extensive, diffuse multivessel disease in which stent implantation could result in extensive stent length – and the other opportunity would be in bifurcations especially in instant restenosis situations. One of the considerations for the use of drug-eluting balloons in these high-risk patients however would also be the potential for drug-drug interactions. Most drug-eluting balloons to date, but not all, utilize the drug paclitaxel. Many of our drug-eluting stents utilize everolimus, sirolimus, and zotarolimus alternative drugs. The potential for drug-drug interaction or the potential for using a paclitaxel-eluting balloon, for example, for the treatment of a drug-eluting stent with a permanent polymer, are safety issues that still remain outstanding. All together we have very limited data with regard to the late-term use of drug-eluting balloons, their late-term efficacy and sustainability for avoiding adverse events. I think, to be sure, there is a great deal of promise and opportunity for them.
  《国际循环》:药物洗脱球囊预防不良事件的远期效果如何?对高危患者是否有必要使用药物洗脱球囊?
  Dr Kandzari:目前在美国,药物洗脱球囊尚未获得批准用于冠状动脉和外周血管的介入治疗。从更广泛的角度来说,我们必须认识到,药物洗脱球囊最初是在下肢血运重建领域进行研究的,(尽管已经开始)在冠状动脉介入中的应用资料还非常少。但我们相信在高危患者中有许多机会用到药物洗脱球囊——如非常广泛、弥散的多支血管病变,如全部置入支架将导致支架过长——其他如分叉病变、尤其是再狭窄的情况下。在使用药物洗脱球囊时必须考虑的问题之一是,这些高危患者存在发生药物-药物相互作用的潜在可能。截至目前,多数药物洗脱球囊使用的是紫杉醇。我们使用的许多药物洗脱球囊携载了依维莫司、西罗莫司和佐他莫司等替代药物。例如,在治疗永久性聚合物药物洗脱支架置入后再狭窄的病例时,就存在药物间相互作用的可能性,这是目前仍然十分突出的安全性问题。总之,对于药物洗脱球囊的晚期使用,以及其预防不良事件的晚期有效性和可持续性,我们目前的资料还很少。但我确信,药物洗脱球囊有很好的应用前景和机会。
  International Circulation: There is still a concern of thrombosis risk with DES in STEMI patients. Do you think DES should be the first choice for STEMI patients?
  Dr Kandzari: We should recognize that no matter what type of stent we use, whether it be a drug-eluting stent or a bare-metal stent, ST-elevation myocardial infarction, and probably only paralleled by chronic kidney disease and to a lesser extent diabetes, are the three biggest risk factors for stent thrombosis. As we have seen in trials like HORIZONS through long-term follow-up comparing a bare-metal stent versus a paclitaxel-eluting stent, not only do the outcomes of stent thrombosis not statistically differ between the two stent types, but the event rates are high again no matter what type of stent we use. With that background, I think the use of a drug-eluting stent has not only proven efficacious in avoiding repeat revascularization but relative to bare metal stents, it has proven fairly safe. There are even more recent contemporary data that are a little more hypothesis-generating rather than conclusive, but they seem to suggest that drug-eluting stents, at least for selective DES, have a potential advantage and even a safety outcome as well. For the broader use of drug-eluting stents however, one of the challenges of treating patients with STEMI is that there is little opportunity for discussion between the doctor and the patient regarding other comorbidities, regarding the need for forthcoming unplanned surgeries, regarding the adherence or opportunity for compliance or adherence to dual antiplatelet therapy. These are some of the challenges in a broad blanket conclusion to using drug-eluting stents in all ST-elevation myocardial infarction patients. Maybe our best step forward is from the HORIZONS trial, which applies a very simple model or scoring system for lesion length, for the vessel diameter and for the presence or absence of diabetes, and if the patients score especially with all three of these variables (i.e. they have a small vessel, a long lesion and they are diabetic) clearly the relative advantage of a drug-eluting stent and avoiding repeat revascularization is going to be even greater. There is a still a bit of individualized therapy for the selection of drug-eluting stents. As a general standard of care, I think the data is fairly sufficient to support that.
  《国际循环》:对于DES治疗STEMI患者,仍有很多学者担心起血栓形成的风险。您认为应将DES视为STEMI患者的第一选择吗?
  Dr Kandzari:我们应认识到,不论使用哪种支架,不论是药物洗脱支架还是裸金属支架,ST段抬高心肌梗死和慢性肾脏疾病以及糖尿病,是支架内血栓形成的3个最主要的危险因素。正如我们在HORIZONS等临床试验中所看到的,裸金属支架和紫杉醇洗脱支架的长期随访结果对比显示,不仅支架内血栓形成的发生率没有统计学差异,而且其他事件发生率也与所使用的支架类型无关。鉴于这种背景,我认为药物洗脱支架并未被证明比裸金属支架能够更有效地预防再次血运重建;并且与裸金属支架相比,其安全性也是相同的。近期研究的一些短期数据与其说是结论,不如说是更偏向于来自理论上的推断:这些数据似乎提示药物洗脱支架,尤其是特定类型的DES,安全性与裸金属支架相似,而疗效似乎更有优势。至于更广泛地使用DES治疗STEMI或者,主要的挑战在于医生和患者很少有机会去充分讨论关于患者的其他合并症、未来不确定的外科手术、治疗依从性或对双联抗血小板治疗的坚持程度等问题。这些是对所有STEMI患者均使用DES的问题作出结论前存在的一些挑战。我们向前迈进的最好依据可能是来自HORIZONS试验的启示,该研究使用了一种非常简单的模型或评分系统,该系统包含病变长度、血管直径和有无糖尿病,如果1例患者的评分涵盖了所有3项参数(即血管细小、长病变、合并糖尿病),那么显然置入DES及其预防再次血运重建的相对优势可能更大。还有一些支持选择DES的个体化疗法。作为总的治疗原则,我认为目前的数据足以支持上述观点。

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DES支架内血栓药物洗脱球囊 Dacid E. kandzari

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