<International Circulation>: What are some of your thoughts on the FREEDOM trial?
　　Dr. Stone: The results of the FREEDOM of trial were very similar to what we saw with the three-vessel arm subset of the SYNTAX trial. In these study， there were patients principally with three-vessel disease—in FREEDOM， with diabetes， in SYNTAX， with or without—who were treated with first generation， drug-eluting stents. Compared with CABG， these patients overall fared better with bypass surgery. It was primarily in patients with more complex diseases where surgery was more favorable. In the FREEDOM trial， there was quite a substantial reduction of stroke with PCI when compared to surgery， however， that was offset by an increase in all-cause mortality， which barely reached statistical significance at five years， and more importantly， an increase in spontaneous MI in the post-procedural period. I think the results of the two studies are fairly consistent. At least from the data we have， with first-generation stents and without optimal techniques， without FFR guided lesion selection， without routine use of intravascular ultrasound， with very complex and advanced coronary artery disease， with or without diabetes， patients should most likely be treated with surgery. However， in patients with less complex coronary disease or left main disease， and with a low or intermediate SYNTAX score， angioplasty maybe a very reasonable option. The EXCEL trial is currently analyzing this question. In this study， they are using state-of-the-art drug eluting stents. That is an important differentiator for these trials. The current drug-eluting stents， in particular the everolimus eluting stents， reduce stent thrombosis by about 70% when compared with both first-generation and bare metal stents. They are also associated with reduced rates of MI and， compared to some of earlier stents， restenosis and target vessel revascularization. These studies， as is often the case， they need to be reviewed with the most current technology.

　　《国际循环》：您如何评价FREEDOM试验？

　　Stone博士：FREEDOM试验的结果与我们在SYNTAX试验中三支血管病变亚组观察到的结果相近。这两项试验中，均纳入了主要为三支血管病变——FREEDOM试验中合并糖尿病、SYNTAX试验中有或无糖尿病——而接受第一代药物洗脱支架置入的患者。这些患者整体疗效甚至比冠状动脉旁路移植术（CABG）更好。这一结果是在通常认为应优先选择外科手术的复杂病变患者中取得的。FREEDOM试验结果显示，PCI治疗组与手术组相比，卒中发生率显著更低，但这种获益部分被全因死亡率升高所抵消，5年时刚达到统计学差异；更重要的是，PCI术后自发性心肌梗死（MI）的发生率升高。我认为这2项试验的结果相当一致。至少从我们目前所获得的数据来看，对于有或无糖尿病的非常复杂和严重的冠心病，若无最佳技术、FFR指导的病变选择和血管腔内超声的常规应用，多数应采用外科手术而非使用第一代药物洗脱支架的介入治疗。而对于复杂程度较低的冠状动脉病变或左主干病变，以及低-中SYNTAX积分的患者，血管成形术可能是一种非常合理的选择。EXCEL试验正在分析这一问题，该试验使用了当前最先进的药物洗脱支架，这也是类似试验中非常重要的一个区分因素。当前最新的药物洗脱支架，尤其是依维莫司洗脱支架，其支架内血栓形成的发生率较第一代药物洗脱支架和金属裸支架降低近70%；且MI、再狭窄和靶血管血运重建的发生率较一些先前的支架亦显著降低。这些研究需要采用当前最先进的技术加以审核。
　　<International Circulation>: Do you think FREEDOM will change the way that you practice?
　　Dr. Stone: I think it will cement what we saw in the three-vessel disease arm of SYNTAX. That is， patients with predominately three-vessel disease， and now with diabetes， will be referred to surgery or certainly a surgeon should be involved if consulting with the patient as to the benefits and risks of the surgery， as opposed to PCI. There will be an active discussion of patients 1) with less advanced coronary artery disease， in which I think PCI is still very appropriate and 2) there will be a lot of patients who prefer a less invasive approach and a lot of patients who are concerned about the risk of stroke， which will be less with PCI than surgery. Clearly， after all cause mortality， stroke is the most feared complication. In some patients， they actually fear stroke more than death and will do anything to try to avoid stroke. In FREEDOM， the risk of stroke was more than doubled when compared with PCI， especially in the early post-procedural period. There will also be discussion of individualizing care for patients and how the complexity of CAD relates to bypass surgery versus intervention and patient and physician preferences. I believe that FREEDOM adds an important piece of evidence-based medicine to the puzzle， especially as it relates to comparison of bypass surgery to first-generation drug eluting stents.

　　《国际循环》：您认为FREEDOM试验结果是否会改变您的医疗实践？
　　Stone博士：我认为FREEDOM试验结果进一步巩固了我们在SYNTAX试验三支血管病变亚组取得的证据，即合并糖尿病的三支血管病变患者应首选外科手术治疗，或者说在与患者就外科手术与PCI相比的利弊进行沟通的团队中理应包括一名外科医生。和患者应进行充分讨论：①冠状动脉病变复杂程度较低的患者，我认为PCI是非常合理的选择；②大量患者会选择微创的治疗方式，还有许多患者更多地考虑PCI较手术更低的卒中风险。显然，卒中是继全因死亡之后第二位的最可怕的并发症。部分患者对卒中非常恐惧，以至于为避免卒中愿付出任何代价。FREEDOM试验中，手术组卒中风险较PCI组增加超过2倍，尤其是发生于术后早期的卒中。讨论还应涉及患者的个体化治疗、冠心病复杂程度与CABG和介入治疗有何关联、以及患者和医生的倾向性等问题。我相信FREEDOM试验为解决上述困惑增加了一项非常重要的循证医学证据，特别是对于旁路移植手术与第一代药物洗脱支架的对比。

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