International Circulation:   What is the difference between the Nevo stent and the Cypher stent? What are some of the design innovations?

国际循环：Nevo支架和Cypher支架之间有何差别？设计创新有哪些？

Prof. Spaulding: There are several innovations. The first innovation is the platform. The platform is a chromium/cobalt platform that is an open-cell thin strut design. Therefore it is very flexible and will be easier to deliver compared to the Cypher stent. The two other new features on the stent are reservoir technology and the use of a biodegradable polymer. The advantage of the biodegradable polymer is that the polymer and the drug are embedded in the stent and therefore there is a reduction of the contact between the polymer and the surface and therefore in animal studies it reduces inflammation and could potentially reduce stent thrombosis in clinical trials. The other new feature is a biodegradable polymer that is completely absorbed after 3~4 months. In animal studies there has been less inflammation and therefore it is potentially a source of a reduction of stent thrombosis. Those are the differences.

On the other hand， what has remained the same is the use of sirolimus， which is one of the most effective and very well proven drugs， and the kinetics of release of that drug have been very carefully tailored so that the tissue content is similar or even slightly better than what was obtained with Cypher.

Prof. Spaulding: （Nevo支架）有一些创新，首先是平台方面的创新。这是一种铬/钴平台，属于一种开环薄型支撑设计，因而非常柔韧，比Cypher支架更易放置。这种支架还有另外两个特点，即采用了储存槽技术并应用生物可降解聚合物。生物可降解聚合体的优点：聚合体和药物被埋入支架中，使得聚合体与表面之间的接触减少，从而在动物研究中发现可减少炎症的发生，并有可能在临床试验中减少支架血栓形成。这种聚合物还有一个新特点是：是一种3~4个月后可以被完全吸收的生物可降解聚合体。在动物研究中，炎症较少发生，因而很可能有助于减少支架血栓的发生。以上这些就是Nevo支架和Cypher支架不同的地方。

另一方面，两者的相同之处是西罗莫司的使用，它是最有效的、并得到充分证明的药物之一。Nevo支架中，对这一药物的释放动力学进行了非常仔细的调整，从而使组织含量相似于甚至略优于使用Cypher支架可达到的含量.

International Circulation: What are the advantages of the reservoir technology?

国际循环: 储存槽技术的优点是什么？

Prof. Spaulding: There are essentially two advantages of the reservoir design. The first advantage is that it reduces the contact between the polymer and the surface and therefore it potentially reduces inflammation. The second thing is that the polymer is in the stent and it will not be damaged when you implant the stent， especially in very heavily calcified tortuous lesions.

Another additional feature for the future is the ability to be able to use these reservoirs to be able to deliver other drugs. Perhaps in the near future we can have stents that not only deliver sirolimus， but also other drugs tailored to the needs of the patient. For example， we can use a drug that can be used in acute myocardial infarction to reduced tissue injury， a drug thatn reduce thrombus， a drug that can be tailored to diabetic patients， etc.

Prof. Spaulding: 储存槽设计主要有两个优点。第一个优点是它减少了聚合体和表面之间的接触，从而有可能减少炎症的发生。第二点是聚合体存在支架中，在置入支架时它不会被损坏，尤其是在严重钙化迂曲的病变中。

对于将来而言，另一个特点是能够使用这些储存槽运送其它药物。或许在不久的将来，我们可以拥有不仅能够运送西罗莫司还可以运送其它药物的以满足患者需要的特制支架。例如，可用于急性心肌梗死以减轻组织损伤的药物，可以减少血栓形成的药物，糖尿病患者所需要的药物，等等。

International Circulation: Why was the Taxus Liberte selected as the comparator stent for this head-to-head trial?

国际循环: 为什么选用Taxus Liberte作为这一头对头试验的比较支架？

Prof. Spaulding: There was a lot of debate a few years ago when we designed the trial. The Taxus Liberte was the stent that was the most widely used in the world so we decided to compare ourselves to the reference on the market. That is the main reason.

Prof. Spaulding: 几年前在我们设计这个试验时存在诸多争论。Taxus Liberte支架当时在全世界的应用最为广泛，所以我们决定利用它作为市场上的比较对象，将我们的支架与其进行比较。这是主要原因。

International Circulation: There are going to be follow-on studies as well?

国际循环: 还会有后继研究吗？

Prof. Spaulding: That is correct. The other studies are the Nevo Res II study， which is a randomized trial， and the comparator will be the Xience V and the Nevo Res III study will be a registry that will be performed in the U.S.

Prof. Spaulding: 是的。其它研究包括，Nevo Res II研究，这是一项随机试验，其比较对象是Xience V支架；还有Nevo Res III研究，将在美国注册实施。

International Circulation: In patients with complex coronary disease and diabetes which one has the best risk-to-benefit ratio， PCI or CABG?

国际循环: 在复杂冠动脉疾病和糖尿病的患者中，PCI和CABG何者的风险-受益比率最佳？

Prof. Spaulding: I work in France and we have just finished four months of difficult debates over the recommendations for reimbursement for drug-eluting stents that we put in for diabetic patients. For diabetic patients with mulitivessel disease CABG is the gold standard and is superior. However， there are many patients with diabetes in whom there is clearly an indication for PCI. Firstly， there are many patients in whom CABG is not possible because they are high-risk patients. Secondly， I believe that a patient with a single vessel disease or two simple lesions on two different arteries can be treated by PCI using drug-eluting stents with the data that we have now.

The message regarding diabetic patients is that they are a very complex group and a very difficult group of patients to treat. When you are treating diabetic patients， you must meet with the surgeon， the non-interventional cardiologist to talk about medical treatment instead of surgery or PCI， and then choose between PCI and CABG based on the evaluation of the Euroscore， which will give you an idea of comorbidities， and the Syntax score， which will give you an idea of the coronary artery lesions. Once you decide to do PCI， it should be performed with the most effective drug-eluting stents.

Prof. Spaulding: 我在法国工作，我们刚刚结束了长达四个月的艰难辩论，其主题就是为糖尿病患者放置药物洗脱支架的报销赔付提供建议。对于有多支血管病变的糖尿病患者，CABG是金标准，且优于PCI。但是有许多糖尿病患者明显具有接受PCI的指征。第一，有许多患者因为属于高危患者而无法接受CABG。第二，根据我们目前掌握的资料，我认为对于单支血管病变或者在两支不同的动脉有两个单纯病变的患者，可以用药物洗脱支架行PCI治疗。

关于糖尿病患者需要知道的是，他们是一组非常复杂的人群，也是一组治疗非常困难的患者。当你治疗糖尿病患者时，你必须与外科医生、非介入心脏病专家开会商讨除了手术或PCI以外的药物治疗，然后根据Euroscore和Syntax score在PCI和CABG之间进行选择，Euroscore会为你提供合并症情况，而Syntax score提供的是冠状动脉病变情况。一旦决定行PCI，则应该使用最有效的药物洗脱支架。

International Circulation: It appears to be more critical to with diabetic patients that you have a team approach.

国际循环: 对于糖尿病患者似乎团队工作方式更关键。

Prof. Spaulding. Yes， definitely. It is team approach， especially with diabetic patients. Perhaps there was a lot of focus on the team approach being a team with an interventional cardi