Patrick W. Serruys教授专访:FAME研究和SYNTAX研究启示
SYNTAX研究是一个里程碑式的试验。它是一个所有患者的试验,没有排除或选入标准,所有患者都基于外科专家与介入心脏病学专家的讨论,称之为“medical conference of the heart team”。研究者使用两种或三种评分系统对患者进行评估: Euro-Score评分系统、Parsonnet评分系统和SYNTAX评分。其中一个是关于并存病变,另一个多是关于病变的解剖学。
International Circulation: I’m here today with Professor Patrick Serruys at CIT 2009. Welcome, it is a great honor to speak to you today. So according to FAME trial, the routine measurement of fractional flow reserve (FFR) during angioplasty in patients with multivessel disease significantly improves clinical outcomes. What can we learn from the FAME trial? Does it mean that physiologic assessment of stenosis is much better than the traditional angiography?
Prof. Serruys: I think people like Nico Pijls and Bernard De Bruyne who pioneered this technique almost more than fifteen years ago have repeatedly demonstrated that the fractional flow reserve is certainly more reliable than the visual assessment and even the quantitative assessment of the angiography. It is more reliable in terms of demonstrating flow limiting lesions and therefore they have some impact on the prognosis of the patient in the long term. And I think that in FAME for the first time in the field of two and three vessel disease they tried to demonstrate the good sense of being selective in dilating some lesions and leaving the other lesions untouched. They demonstrate their point by an impact on MACCE (major adverse cardiac and cerebral events). Of course if instead of treating 2.7 lesions you treat just 1.9 to 1, which are necessary to be treated - which need to be treated then obviously you can avoid a certain number of problems.
International Circulation: What else? Any other significant lessons we can learn from FAME. Any other lessons or what do you feel are some key information?
Professor Serruys: Of course it is the first year follow up so we have to see if it is translated into the long term prognosis but previously they did something similar with a trial called DEFER which had the long term follow up also confirmed the fact that if you are very selective in treating the lesions, you have good long term and short term follow up. The questions is of course to what extent can you apply complex population, the SYNTAX score of FAME is about 14.5, the SYNTAX score of SYNTAX is above 27 so we’re not talking about the same population. So the practicality of measuring the fractional flow reserve in every patient might be more difficult than in these other simple populations.
International Circulation: What about patients with multivessel lesions, how can we detect targeting lesions in those patients?
Professor Serruys: Basically you should start by if you do not have a non-invasive test to show the region of ischemia, I think the first conventional test is to have the best Qc (Pulmonary Capillary Blood Flow) that you could have. In FAME they have the diameter stenosis of 60-61% classically as an average and in these lesions which are not super narrow, I think it is a good decision to advance a pressure wire and measure the fractional flow reserve during hyperemia.
International Circulation: You mentioned the SYNTAX trial just now, first of all can you comment on it. Do you agree that it is a landmark trial?
Professor Serruys: Yes, I think it is a very important trial. In my career, it is the fourth trial that I did since 1987 with the CABG trial. I think there are four major components. It is an all comers trial, that is very important. There are no selection and no exclusion or inclusion criteria. So the third very important point is that everything is based between a discussion between the surgeon and the intervention cardiologist. That is what we call the concept of the medical conference of the heart team. And the surgeon and the interventional cardiologist look at the patient with two or three instruments: the Euro-Score, the Parsonnet score, and the SYNTAX score. One is about the co morbidities; the other is more about the anatomy of the lesions. And then it is clear that after these discussions, for a certain number of cases the interventional cardiologists just say to the surgeon “I cannot do it, it is too complex, too risky. It will take too much time” and then the patient will go to the registry for surgery. Only the patients amenable for surgery go into this registry. Vice versa in the small number of patients because the first group the surgical registry are about 1/3 of the patients. And then there is a small group of less than two hundred patients where it is the surgeon that says too much co-morbidities, or a problem with aorta, whatever, so the patient has to do an angioplasty. And then finally we have 1800 patients where the patients were randomized. In that population, globally, the MACCE spread of the three vessel disease mixed with the main stem, the gap in MACCE grade was about 5.5% but the rules of engagement, the statistical game, was that we could not go about these small differences to prove the non inferiority. So globally we did not reach the non inferiority but I think the major introduction, the major asset for these trials was the fact that we used the SYNTAX score. By looking at the specific SYNTAX score we could see which patients could be treated by PCI and which patient should be treated by surgery.
International Circulation: And sometimes there are different people looking at trials at a different way. Since ESC last year and we are talking more about SYNTAX, have you found it that perhaps there is any difference in view between the interventionalists and the surgeon and how to interpret SYNTAX, can you talk about that?
Professor Serruys: That is a good question. I mean I think the first time the trial was presented I think that people left the room with the idea that an interventionalist cardiologist failed. That sometimes it was the surgeon leaving the room saying that the taboo on the main stent has been broken. So everybody has his interpretation. For me, the key point, the really key point is that with the SYNTAX score we have a kind of detailed common language and we can really communicate with some subtle ease. Before that it was the left main and the three vessel disease and it could be everything. It could be a mixed pack of difficult and simple case. Now we have an accreditation, a grading of these kinds of patients. That I think is maybe the best legacy of the trial.
早在15年前Nico Pijls和Bernard De Bruyne这些前辈就提倡应用血流储备分数(FFR)测量技术,并反复声明其比直观指标甚至血管造影定量指标更可靠,尤其是判定缺血性病变时,其对患者的长期预后有一定影响。FAME研究中多支血管病变患者常规血流储备分数测量指导血管成形术能明显改善临床疗效。在此研究中第一次尝试对两支和三支血管病变有选择性的扩张某些病变而不处理其他病变,并通过对MACCE(主要心脑不良血管事件)的影响证实了这种做法。显然,相对于治疗2.7个病变,只治疗1~1.9个必须治疗的病变,能避免许多问题。
当然,这只是FAME研究第1年随访结果,还需要继续观察其对长期预后的影响,FAME研究与DEFER研究有相似之处,如果高度选择性地治疗病变将会获得好的长期和短期随访疗效。问题在于它适用的复杂人群的范围。FAME研究的SYNTAX评分约为14.5,SYNTAX研究的SYNTAX评分在27以上,这是不同的研究群体。因此,对每个患者均进行血流储备分数测量可能比在这些病变较简单的群体中实施起来更加困难。
多支血管病变患者要检测靶病变,如果未通过非侵入性试验判定缺血区域,首先应常规检测Qc(肺毛细血管血流量),FAME研究中,患者病变平均直径狭窄60~61%,并非极严重的狭窄,用压力导丝测定血流储备分数是一个很好的方法。
SYNTAX研究是一个里程碑式的试验。它是一个所有患者的试验,没有排除或选入标准,所有患者都基于外科专家与介入心脏病学专家的讨论,称之为“medical conference of the heart team”。研究者使用两种或三种评分系统对患者进行评估: Euro-Score评分系统、Parsonnet评分系统和SYNTAX评分。其中一个是关于并存病变,另一个多是关于病变的解剖学。经讨<