International Circulation: I’m here with Professor Eric Eeckhout at CIT 2009. I would like to talk in general first about clinical trials. We know there were a lot of landmark studies that were issued at ESC congresses in recent years. This has influenced clinical guidelines and practice. But in China， large scale， multicentre clinical trials are really rare， so can you give us the benefit of your experience and perhaps some of your advice on that issue?

国际循环：近年来在美国ACC/AHA/TCT及欧洲ESC/EuroPCR等年会上公布的一些里程碑性的研究对指南的制定和修订均起到了非常重要的作用。但中国目前这样的大规模、多中心临床试验还很少，您能否给中国的同行提一些意见或建议？

Dr. Eeckhout: I think we should stay open-minded. I think we have seen in the US and also in Europe， a lot of important landmark trials in the field of PCI. At the start of this century the landmark trial with the drug-eluting stent， the first trials to be presented in 2001， and we have then seen a lot of randomized trials confirming these results， over time， very quickly and then we have seen very important trials in contemporary PCI technique; multi-vessel， left main， stenting versus CABG. All of these trials have been completed and one year’s results have been presented last year at the ESC conference. It is a lot of information and I think we can talk about it for quite some time. What would this mean for a country like China? I think there is a lot of place for potentially repeating a SYNTAX-like trial because we had a hard time to have this in Europe， but potentially with new stent technology with biodegradable polymers， drug-eluting stents that turn into bare-metal stents after 9 to 6 months. There is new technology in drug-eluting balloons - there is a lot of PCI technology. I think it has to be challenged again against CABG.

Dr. Eeckhout：“解放思想”，这是我最想告诉中国同行的一句话。正如您所说，在冠状动脉介入治疗领域，每年都有一些具有里程碑意义的临床试验在美国或欧洲的心血管年会上公布。自从2001年ESC年会上公布第一项药物洗脱支架临床试验以来，已陆续有大量的随机对照试验结果发表，包括各种最新的PCI技术、PCI在多支病变或左主干病变中的应用及支架置入术与CABG的对比研究等，这些试验为我们提供了大量的信息。大量的病例资源是中国特有的优势，我觉得可以利用这一优势重复开展一些类似于SYNTAX研究的临床试验，但可以选择新一代药物洗脱支架如生物可降解聚合物支架（6-9个月后变成金属裸支架）进行验证。另外在技术方面，药物洗脱球囊也是未来研究的方向之一。

International Circulation: This leads into my next question. For patients with left main lesion or multi-vessel lesions， obviously there are different opinions on CABG or drug-eluting stents. Could you share some of your experience in this area?

国际循环：目前对于无保护左主干病变，究竟是置入药物洗脱支架还是CABG治疗对患者获益更大还存在争议。能否和我们分享一下您在这方面的经验？

Dr. Eeckhout: Indeed I alluded to that in the first question. The main issue is SYNTAX. SYNTAX is this large randomized trial. TAXUS Express Stent， to be mentioned， is a first generation drug-eluting stent， not even what they are using now. TAXUS Express Stents are compared to surgery in multi-vessel and left main disease， well the results were presented last summer at the ESC conference and it seemed to be at first sight that everyone was happy. The surgeons were satisfied because there were more events with PCI but also the interventional cardiologists were satisfied because there was no safety issue， there was no difference in terms of micro-infarction mortality. There was even， as you may know，  relatively more strokes in the CABG group. So people were quite satisfied that when the complication came out， we know the paper was published in the NEJM about two or three weeks ago， a lot of interventional cardiologists were quite disappointed， because as you can see from the last line of this article， it is written that surgery is still the treatment of choice and I think that many/several interventional cardiologists do not adhere to this principle.

Dr. Eeckhout：2008年ESC年会上公布了SYNTAX试验中期结果，该试验是首个针对左主干和三支血管病变比较CABG与PCI有效性及安全性的大规模随机对照研究，主要终点是12个月的主要不良心脑血管事件，包括死亡、脑卒中、心肌梗死及靶血管再次血运重建。1年随访结果表明，PCI组和CABG组的安全性（包括死亡、脑卒中和心肌梗死）是相当的（7.6% vs. 7.7%），PCI组靶血管再次血运重建率显著高于CABG组(13.7%对5.9%)，而CABG组脑卒中发生率显著高于PCI组(2.2% vs. 0.6%)。PCI和CABG组全因死亡率(4.3% vs. 3.5%)及心肌梗死发生率(4.8% vs. 3.2%)均无显著差异，CABG组症状性桥血管闭塞率与PCI组支架血栓发生率也无显著差异。无论心内科医生还是心外科医生都对这一结果表示满意，在心外科医生看来，PCI治疗的靶血管再次血运重建率依然显著高于CABG治疗；而在心内科医生看来，PCI治疗不存在安全性问题，也没有显著增加微梗死相关的死亡率，而且CABG组脑卒中的发生率相对更高。2009年2月，SYNTAX试验的最终结果在新英格兰医学杂志上发表以后，许多介入医生对此深感失望，因为文章最后的结论指出CABG仍然是左主干病变合理的选择。可以想象，很多介入医生在临床实践中不会完全遵循这一结论。

International Circulation: How will this affect us?

国际循环：SYNTAX试验结果对于指导临床实践会产生多大的影响？

Dr. Eeckhout: Well I think it will have a major impact in the US because， as you know， in the US if you have a randomized trial and you publish this kind of data in the trial， for many reasons， people have to stick to this information. So I think there will be a decrease of multi-vessel /left main PCI in the States except for compassionate use. I think， knowing the old continent， nothing will change in Europe because practice will stay the same and I am confident that nothing will change in China and in Asia in general. People will continue to do left main stenting and multi-vessel stenting. I wouldn’t say we should have an unlimited behavior. I think we should be careful. I think we should really be careful about distal left main stenting because surgery is still doing better. I still think that putting more than ten centimeters of drug-eluting stent in a vessel certainly if it is longitudinal， is certainly not the way to go. So I think we must be really careful as interventional cardiologists when we choose and propose， I would say propose，  stenting rather than surgery to a left main or a multi-vessel diseased patient.

Dr. Eeckhout：在不同的国家和地区，影响是不一样的。在美国，受到多种因素的制约，一项随机对照试验结果发表以后，研究结论对指导临床实践在某种程度上具有一定的强制性，医生必须要遵守。因此，我认为在美国未来多支血管病变或左主干病变进行PCI治疗的比例会下降。但在欧洲和亚洲，我认为影响不会很大，中国总体上也是这样，介入医生会继续为多支血管病变或左主干病变患者置入支架。我的意思并不是说医生的执业行为不应受到限制，而是说我们要小心行事。尤其对于左主干远端分叉病变，外科手术的效果依然要优于介入治疗。另外，我认为在一支血管内置入超过10cm的药物洗脱支架也是不可取的。因此，当我们为患者制定治疗决策或提出建议时，必须小心谨慎。

International Circulation: It’s a topic here at CIT and I would like to ask you your opinion on this. What is more important: angiographic measures or clinical outcomes in assessing drug-eluting stent efficacy?

国际循环：对于评价新一代药物洗脱支架的有效性与安全性，您认为造影随访结果还是临床随访结果更加重要？

Dr. Eeckhout: For the first-in-man you need everything for sure. The FDA， also the European legislation， certainly also the Chinese and all other legislations require for first-in-man data in detail， they need animal studies and then they need angiograp