多支病变中CABG比药物支架有更低的死亡和心肌梗死

来源：医心网发布时间：2008-02-02 09:07

Fewer deaths, MI, with CABG than DES for multivessel disease in NY State

　　一个新研究发现2003年10月1日至2004年12月31日期间在纽约州多支病变患者中CABG比药物洗脱支架有更低的18个月死亡率，这是首个大规模多中心再血管化策略对比，应引起临床医生对这两种治疗策略选择进行重新审视。

　　该研究中多支病变患者CABG和DES相比死亡率降低了20-29％，死亡和心肌梗死降低了25%-29%，再血管化比例也显著降低，研究发表在2008年1月的新英格兰医学杂志上。主要作者Edward L Hannan (University at Albany, NY)说，“很明显医生和患者应注意到该研究，有其他单中心研究得出相似结论即即使在DES应用的年代长期预后仍是CABG更好。” Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles, CA)对该研究发表了评论。“该研究结果强调CABG因为其降低死亡率、再次血运重建和缓解心绞痛方面的获益，多支病变和左主干治疗的金标准，在FREEDOM、SYNTAX和VA CARDS等试验结果发表前医生应将CABG做为多支病变和左主干病变治疗的更好策略。”

　　但该研究是注册研究，研究没有涉及病情非常严重不能作CABG 而作了PCI的患者，也没有支架患者的完成资料，另外没有左主干患者的亚组分析。

　　Ron Waksman (Washington Hospital, DC)评论指出最近他们也得到了相似的发现，“问题是并不是所有三支病变都是一样的，可以是弥漫长病变、CTO等等，也可以是三个局限的病变，随机分组非常重要，这也是我们要等待SYNTAX试验得出结论的原因。”

　　但外科医生已经警告其患者多支病变中DES的不足，“这些结果和其他早期CABG与裸支架比较研究一致，即支持CABG，也显示了CABG在生存方面的益处。”

　　CABG有更少的不良事件

　　该研究中CABG组7437例，DES组9963例，比较两组的死亡和心肌梗死，三支病变CABG校正的死亡相对危险度0.8，双支病变为0.71，死亡和心肌梗死联合终点结果也相似，CABG组再血管化也显著降低。

　　两支和三支病变CABG和PCI对比

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
终点　　　　　　　　CABG (%) 　　　　　　　DES (%)　　　　　　　p

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－
生存
三支病变　　　　　　　94 　　　　　　　　　　　92.7　　　　　　　0.03
双支病变　　　　　　　96 　　　　　　　　　　　94.6 　　　　　　0.003
无MI生存
三支病变　　　　　　　92.1 　　　　　　　　　　89.7 　　　　　　<0.001
双支病变　　　　　　　94.5 　　　　　　　　　　92.5 　　　　　　<0.001

－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－

　　80岁以上老年患者或射血分数小于40%的患者CABG也有更好的生存，尽管无显著性差异，但糖尿病亚组中也支持CABG。Hannan指出糖尿病将是未来研究的一个特殊亚组，有研究指出在糖尿病患者中CABG更好，“我们需要这方面的数据，需要识别哪一特定亚组能从支架中获益，或CABG和支架没有显著差异，因为如果没有显著差异，那么患者可能会选择支架，因为其创伤更小。”

　　Waksman教授认为糖尿病中的研究结果是不一致的，注册研究有其固有的局限性和缺陷，在有争议的患者中需要更多的研究。Kaul等指出两组绝对危险的差异很小，三支病变中死亡差异是1.3％，死亡和心肌梗死联合是2.4％，双支病变中死亡差异是1.4％，死亡和心肌梗死联合是2.0％，也就是说更长期随访可能得出CABG更明显的获益，因为CABG益处需要长期才能体现，而DES可能会有晚期血栓的问题。

　　也有人指出CABG和支架组是否完全再血管化还缺乏资料，也没有二联抗血小板治疗的资料，Joseph P Carrozza (Harvard Medical School, Boston, MA)在述评中指出Hannan等的研究要注意延长二联抗血小板治疗的问题，DES治疗的患者较短期的二联抗血小板治疗可能会导致更多的死亡。对于完全再血管化问题作者承认“有些地方我们资料不足，还需要进一步研究。”他们正在进行这方面的研究，结果将于近期发表，多支病变仅置入一个支架的患者预后也差于全部病变置入支架，如果DES组能做到完全再血管化，那么结果可能会更好。

　　几乎所有做了评论的专家都同意只有随机试验才能回答这一问题，尽管Hannan指出注册研究也有一定作用，因为随机试验入选患者例数少，难以作亚组分析。Hannan等认为现在的问题如何对医院进行调整，患者作了诊断性造影，然后更可能对非常严重的病变同期完成PCI，而不是再次手术行CABG，外科医生和其他非介入的心脏病医生都呼吁需要谨慎对待。

　　Guyton大力支持这一说法，“这些结果能得出说服力的结论是在进行冠状动脉血运重建前需要对患者预后进行一个充分的讨论，对于多支病变患者不应该做完造影就接着作PCI，尽管正如本研究显示的DES和CABG相比相对死亡风险增加22%－35%，但仍选择PCI，很多患者是不应该作的，我们要给患者更多的信息以帮助患者做出选择。

　　（武警总医院　韩玮　编译）

　　（来源：www.theheart.org）

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2008-02-02 09:11:17 By melody

Fewer deaths, MI, with CABG than DES for multivessel disease in NY State   January 23, 2008  Shelley Wood   Albany, NY - More patients with multivessel disease will die within 18 months if treated with drug-eluting stents (DES) than they will if they undergo CABG surgery—that’s the upshot of an analysis of all patients undergoing those procedures in the State of New York between October 1, 2003 and December 31, 2004. The study is the first large-scale, multicenter comparison of the two modern-day revascularization strategies and should cause physicians to rethink the information and advice they give to patients choosing between the two procedures, experts say.   In the study, patients with either two- or three-vessel disease were 20% to 29% less likely to die and 25% to 29% less likely to die or have an MI if treated with CABG instead of DES; rates of repeat revascularizations were also significantly lower. Results are published in the January 24, 2008 issue of the New England Journal of Medicine. "Certainly, physicians and patients need to be aware of this study," lead author Dr Edward L Hannan (University at Albany, NY) told heartwire. "There are other studies, confined to single hospital settings, that concluded the same thing: that even in the era of DES, the longer-term outcomes favor CABG surgery."   Dr Sanjay Kaul (Cedars-Sinai Medical Center, Los Angeles, CA), commenting on the study for heartwire and who was uninvolved in the study, was more blunt about the results.   "Bottom line: these data underscore the fact that CABG remains the gold standard for patients with multivessel CAD and for left main stenosis, because of its survival advantage, freedom from repeat intervention, and relief of angina," he told heartwire. "Until the results of the ongoing clinical trials such as FREEDOM, SYNTAX, and VA CARDS come out, clinicians would be well-advised that CABG remains the ’winning strategy’ in patients with multivessel and left main disease."   Others, however, warn against making too much of registry results. In this particular study, there are no data on whether patients who got PCI did so because they were too sick to undergo CABG, and there are no data on "completeness" of revascularization in stented patients. Moreover, an important subgroup, patients with left main disease, were not included in the study.   "Overall, the data are the data: they’re probably right," Dr Ron Waksman (Washington Hospital, DC) commented, noting that a recent paper from his group showed similar findings. "The problem is that most people will generalize from these conclusions after publication, and there is three-vessel disease and there is three-vessel disease. Not all three-vessel disease is the same. You can have diffuse long lesions, total occlusions, etc,  and you can have three focal lesions in three vessels. This is where randomization is very important, and I would suggest that we wait for the results of the SYNTAX trial before jumping to conclusions. It’s going to give us a much more accurate answer to this question."   Surgeons, however, point out that they have been warning patients and their peers about the inferiority of DES for multivessel disease for some time. "These results favoring CABG over DES are consistent with earlier studies comparing CABG with bare-metal stents," Dr Robert Guyton, chief of cardiothoracic surgery at Emory University, Atlanta, GA, reminded heartwire. "And it has been shown before that there is no survival benefit or MI benefit of DES over bare-metal stents."   Event rate lower in CABG-treated patients   The study compared death and death/MI in 7437 patients treated with CABG and 9963 treated with DES. After 18 months, the adjusted hazard ratio for death was 0.80 among CABG-treated patients with three-vessel disease and 0.71 for CABG-treated patients with two-vessel disease. Adjusted hazard ratios for the end point of death/MI were similarly reduced for CABG-treated patients as compared with DES-treated patients. Revascularization rates were also dramatically and significantly lower in CABG-treated patients.   Adjusted survival rates for patients with three- and two-vessel disease －－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－ End point　　　　　　　　　　　CABG (%)  　　　　　　　DES (%)　　　　　　　p －－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－ Survival       　　3-vessel disease 　　　　　　　94 　　　　　　　　　　　92.7　　　　　　　0.03 　　2-vessel disease 　　　　　　　96 　　　　　　　　　　　94.6 　　　　　　0.003 MI-free survival   　　3-vessel disease 　　　　　　　92.1 　　　　　　　　　　89.7 　　　　　　<0.001 　　2-vessel disease　　　　　　　94.5 　　　　　　　　　　92.5 　　　　　　<0.001 －－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－－   Patients 80 years and older and patients with ejection fractions less than 40% were also significantly more likely to survive 18 months or survive free of MI if they received CABG. By contrast, there were no significant differences in outcomes between CABG- and DES-treated diabetics, although the results trended in favor of CABG for this subgroup.   Hannan singled out the diabetics as one group that warranted special attention in further studies, given that other reports have more clearly favored CABG over stenting for this group. "We need to explore this in more detail and try to identify precisely which groups either benefit more from stenting or at least for which there is no significant difference between CABG and stenting, because if there is no significant difference in outcomes, patients might opt for stenting because it’s a much less invasive procedure."   Waksman views the diabetic data differently, pointing out that it is a "bizarre" finding that serves as an example of the "deficiencies" of registry-derived data and the potential pitfalls they produce. "You need to look for things that seem to contradict prior literature, and in this case, the diabetes results are very disturbing."   Kaul had other observations about the results, noting that the absolute risk differences between the two groups are relatively modest, ranging from 1.3% for death to 2.4% for death/MI in the patients with three-vessel disease and from 1.4% for death to 2.0% for death/MI in patients with two-vessel disease. That said, "it is quite likely that larger differences would be evident at longer follow-up, because treatment benefits with CABG take longer to materialize and the risk of late stent thrombosis associated with DES begins to emerge after one to two years," Kaul points out. Another point to keep in mind is the lack of data regarding the completeness of revascularization for both CABG, in terms of grafts, and PCI, in terms of number of stents used, Kaul noted, and the lack of information on use of dual antiplatelet therapy. An accompanying editorial by Dr Joseph P Carrozza (Harvard Medical School, Boston, MA) points out that Hannan et al’s study preceded awareness of the need for extended duration of dual antiplatelet therapy: shorter-term antiplatelet drug use might have driven up deaths in the DES-treated patients, Carrozza notes.     "That’s something we don’t have information for, and something that needs to be investigated," Hannan conceded. As to the issue of complete vs incomplete revascularization, Hannan said that this is an issue his group is actively investigating, and a paper addressing this topic is currently under review for publication. Patients with multivessel disease who receive only one stent will have worse results than patients who receive stents for all occluded segments, he explained: DES results would likely be stronger if only patients with "complete revascularization" are compared with CABG-treated patients.   Everyone who spoke with heartwire agreed that the best answers will come from randomized controlled trials, although Hannan pointed out that registries will always play a role, given that randomized trials can never enroll enough patients to provide insights into specific subgroups. Hannan also believes the information is relevant now in the ongoing debate over how to restructure current hospitals, whereby patients who undergo diagnostic catheterizations and are diagnosed with significant occlusions are treated in the same session by PCI. Increasingly, surgeons and noninterventional cardiologists have been calling for the need to "stop the train."   Guyton could not agree more. "These results bring home again the need for full discussion with the patient of outcomes and options prior to coronary revascularization," he told heartwire. "In the case of multivessel disease, the patient should not have a cath and then proceed to PCI while sedated on the cath table. Some patients would choose PCI despite the 22% to 35% relative higher mortality with DES compared with CABG in 18 months shown in this study, but many would not. The patient needs to make the choice with as much information as we can provide." [ 本帖最后由 melody 于 2008-2-2 09:13 编辑 ]

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