International Circulation： Although most of clinical trials demonstrated drug-eluting stents (DES) is safe for CAD patients， we still focus on the safety of DES. What is your opinion about the safety of DES?

《国际循环》：尽管许多临床研究证实DES安全，我们依旧关注DES安全性问题，您如何看待这个问题？

Windecker：I think all the safety debates were initiated during the ESC meeting about two years ago in 2006， and I think there has been an interesting evolution in 2006 and 2007 that was really the concern that immediately weight of death or myocardial infarction will be increased with DES as exposed to bare metal stents. And I think that has changed with data accumulating that first of all in leading indications that there were small evidence of any difference in death and myocardial infarction. And those findings will then also extend to off-label studies large-scale registries. Actually the prevailing finding was that maybe mortality is even somewhat decreased than those patients treated with drug-eluting stents as compared to bare metal stents. So， I think in 2008， people are quite comfortable of that as related to the end-point of death and myocardial infarction that there’s no increased incidence with drug-eluting stents but what we have recognized is that at least the first generation of drug-eluting stents， ten percent higher incidence of what we called very late stent thrombosis and that is a disaster event if the event-associated mortality and morbidity is very high. Yet on the other hand， it is a low-frequency event and therefore probably the balance of benefit on the one side and this harm on the other side comes out in a way that it does not translate in wound or harm with respect to death or myocardial infarction. But obviously here that’s working on improvements， I would not think that we can comment on improvements regarding the long-term safety of new-generation drug-eluting stents， and I think that’s a consistent finding that new stent designs with lower strut thickness. At least it’s associated with lower incidence of periprocedure myocardial infarction. And that should be an advance itself.

The new designs as related to the stent platform that use lower strut thickness as compared to the first-generation eluting stents， are already out， for example endeavor . And therefore they both received FDA approval. As I mentioned I think that they are pretty consistent that they are associated with lower incidence of peri-procedure infarction. But in the data， the preliminary data we found that long-term follow up is also encouraging. Also I think it’s prevalent to make a statement on that. In a new-generation drug-eluting stents using biodegradable polymers there are more efforts in removing the polymer entirely and there are also efforts on completely biodegradable stents. Some of them are already available and some of them will become available very shortly and the other ones completely biodegradable will still need some years on work. 

Windecker教授：新一代支架现已面世，与第一代药物洗脱支架相比，它的支架层更薄。因此，它已经经过了FDA的认证。正如我提到的，研究结果一致表明，这类支架的围手术期心梗发生率更低。在初步数据里，我们还发现长期随访的结果也令人满意。我想很快就会有这方面的报道。新一代药物洗脱支架采用生物降解高分子材料，研究者致力于达到材料完全清除的效果。同时，还有完全可降解支架方面的研究。这些产品有些已经面世，有些很快会面世，而完全生物可降解支架则预计需要数年的时间才能开发成功。

关于安全性的问题是在2年前也就是2006年的ESC年会上提出来的，我认为从2006到2007年有一个很有意思的转变，关注点放到了药物洗脱支架与裸金属支架相比，会提高死亡或心肌梗死的机会的问题上。而我认为，随着数据的积累，首先，主要的研究已表明，没有证据支持两种支架在死亡和心梗风险方面具有差异。上述结果也将推广到大规模回顾性研究中。事实上，现在普遍的结果是，接受药物洗脱支架治疗的患者的死亡率在某种程度上要低于裸金属支架治疗的患者。因此，我想在2008年，因为药物洗脱支架没有增加死亡和心梗终点的发生率，所以人们会很乐意接受这项技术。但是，我们已经认识到，至少在第一代药物洗脱支架，我们所称的非常迟发性支架血栓的发生率要高出一万倍，这是灾难性的事件，因为它会导致极高的发病率和死亡率。但另一方面，该时间的发生低频较低，因此，在它带来的收益和损害之间要寻找一个平衡点，尽力避免导致死亡或心肌梗死的结局。不过，现在各方都在努力改善这个缺陷。在此，我还不能对新一代药物洗脱支架的长期安全性作任何评价。这方面的研究结果一致表明，设计壁层更薄的支架，其围手术期心梗的发生率更低。我想这是一个进步。

International Circulation： Could you please to talk about percutaneous left ventricular assist devices for treatment of patients with cardiogenic shock?

《国际循环》：您可否谈谈处理心源性休克患者时介入性左室支持装置的使用？

Windecker：The cardiogenic shock is still a very malignant disease characterized by a high incidence of mortality. And the treatment of the patients with acute myocardial infarction complicated with cardiac shock is revascularization percutaneously or with coronary artery bypass surgery. However， despite these efforts in opening up the arteries， we are quite often confronted with hemodynamic compromise. That is， we opened up the arteries but still the patients are not doing well. The advent of percutaneous left ventricular assisting devices is welcome because during the critical period when the patients are in hemodynamic compromise. Left ventricular assisting devices can provide circulatory support to assist the intrinsic left ventricular function and can completely replace the intrinsic left ventricular function. There are various left ventricular assisting devices available， but it is very extreme that they can completely replace the intrinsic left ventricular function. Therefore these devices are useful for stabilizing the patients during the procedures. The hope is that during this period the patients have time to recover from procedure to gain enough residual left ventricular function in order to survive. However， unfortunately that is not in all patients in the case， and more aggressive therapies will come into play and more has to think about switching to continuous left ventricular assist device or at the very end of transplantation. Nevertheless I think it is a very useful method in extending therapy options to patients， one that may make survive something what they would not be able to survive and then also offer them extended therapy in case they do not have enough residual left ventricular function.

Windecker教授：心源性休克仍然是非常恶性的疾病，特点是死亡率高。急性紧急梗死伴心源性休克的病人首选治疗是经皮血管重建加冠状动脉搭桥手术。但是，尽管有这些开放动脉的术式，我们还是常常会遇到血液动力学功能障碍的情况，即使开放动脉，但患者的情况仍然没有改善。因此，经皮（介入式）左室支持装置的优点在此便得以发挥，因为在患者血液动力学不稳定的关键时期，这种装置可以提供循环支持，通过循环支持改善心脏的左室入口功能，甚至可以完全取代其功能，因为现有的各种介入左室支持装置的效力很高，可以取代本身的左室功能。因此，我认为这些装置可用于术中稳定患者的情况。从而，患者有希望在手术恢复期恢复足够的左室残余功能，并得以存活。但是，不幸的是，并非所有患者都能够达到这一点，因此需要进行更积极的治疗，考虑采用不间断左室支持装置，或到最后采取移植的手段。不过，我认为这种装置还是非常有用的，为患者提供了更多的治疗选择，也增大了患者生存的机会，如果没有这种装置，患者可能就无法继续存活。它为左室残余功能不足的患者提供了很好的治疗选择。

International Circulation： Acute coronary syndromes are associated with high morbidity and mortality. Early diagnosis and risk stratification are essential for initiation of optimal medical and invasive management. Could you talk about the major advance in diagnosis and treatment of ACS?

《国际循环》：