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[ACC2009]众多患者的首选——PCI,来自SYNTAX分析的论据
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Orland,FL——对于严重的冠心病人来说,搭桥手术在预后方面要优于支架治疗。ACCi2峰会公布的研究结果显示,尽管CABG对于复杂冠脉解剖的病人仍然是首选,但当考虑到生活质量和经济学因素,对简单或中等复杂病变的患者来说PCI要优于CABG,一份对SYNTAX研究进一步分析的报告指出,当考虑生活质量和经济学因素时CABG相对于PCI的优势就不明显了。而冠脉病变的复杂程度成为了决定选择PCI还是CABG的决定因素。
David Cohen(Saint-Luke’s Mid America Heart Institute)说:“医生、患者、指南的制定者及医疗费用承担者都会发现到这条信息在医疗决策的制定及治疗方案的选择方面有很大的帮助。从患者的角度出发,术后生活质量的差异是需要认真考虑的,同样考虑到目前的医疗保健体系中的诸多限制,能够证明一种治疗方式花费更少的证据能够被写到指南中去。
SYNTAX的主体研究入选了1800名确诊的冠脉三支病变和严重左主干病变的患者,随机分为CABG组(n=897)和接受药物洗脱支架治疗的PCI组(n=903)。1年随访结果显示,死亡率、心脏病发作和卒中的发生率在两组中相似,但PCI组再次接受手术治疗的几率要高于CABG组。
进一步分析的目的是观察这两种治疗方式之间在生活质量方面有没有差异。除此之外研究者还观察了患者心脏病对症状、体力限度、疼痛、生活能力方面的影响。另外,研究者收集了实验过程中心血管手术、住院、门诊、医生出诊和药物方面的经济学数据。
他们发现,尽管CABG组的胸痛缓解率要优与PCI组,在1年随访过程中支架和搭桥手术都能改善总体生活质量。在美国的医疗体系下,外科手术初期费用要比介入治疗多6000美元。但是,PCI组在接下来的1年随访中的花费要增加2500美元/人,这主要是因为额外的心脏手术和长期抗血小板治疗。
一份官方的费用/效益分析指出对与整体人群来说,CABG组的临床获益与其高花费并不相称。但是,冠脉病变的复杂程度(由斑块位置、数量、病变长度、是否有钙化、是否有易碎的血凝块等决定)对费用/效益比具有重要的影响。对于简单的三支病变或是左主干病变来说,PCI可以使患者支出较少的花费并获得更好的生活预期。对于中度复杂病变的患者来说也发现了相似的结论。而对于严重的三支病变患者生活预期在CABG组要更好一些,并且两组间在1年的花费上是几乎相等的。
Cohen认为:“最重要的信息是我们不只有一种选择。PCI和CABG治疗左主干和三支病变的花费/效益比取决于冠脉病变的复杂程度但是”。“应该指出我们的分析仅仅限于美国的医疗卫生系统。考虑到医疗模式和医疗资源费用的不同,在其它国家花费/效益比可能会不同。”
对SYNTAX研究中患者的五年随访正在计划中。
(谭凯 吕树铮 首都医科大学附属北京安贞医院)
英文原文:
SYNTAX ANALYSIS FAVORS PCI IN MANY PATIENTS
Quality of Life, Economics Shed New Light on CABG-PCI balance
Orlando, FL – For patients with severe coronary artery disease, bypass surgery may hold an edge over stenting in clinical outcomes. But when quality of life and economics are considered, percutaneous coronary intervention (PCI) gains the upper hand in straightforward and intermediate cases, while bypass surgery is the best choice for those with the most complex coronary anatomy, according to research presented during the i2 Summit at the American College of Cardiology’s 58th annual scientific session.
A new report from the Synergy between PCI with Taxus and Cardiac Surgery (SYNTAX) trial shows that the advantages of bypass surgery are less obvious once quality of life and economic data are included in the analysis. Instead, the complexity of coronary artery disease becomes a major factor in determining whether stenting or surgery is the preferred treatment.
“Clinicians, patients, guideline issuers and payers will find this information helpful in making clinical decisions, as well as in setting treatment priorities,” said David J. Cohen, M.D., MSc, director of cardiovascular research at Saint-Luke’s Mid America Heart Institute and a professor of medicine at the University of Missouri. “From a patient’s perspective, quality of life differences are very important to consider. Similarly, given current constraints within the healthcare system, evidence that one approach is less costly could also be incorporated into treatment guidelines.”
The main SYNTAX trial enrolled 1,800 patients with a build-up of cholesterol plaque in either three coronary arteries or the critically important left main coronary artery, randomly assigning 897 to coronary artery bypass grafting (CABG) and 903 to PCI with drug-coated stents. At the one-year mark, rates of death, heart attack or stroke were similar for the PCI and CABG groups, while the number of repeat heart procedures was significantly higher in the PCI group.
The new study set out to determine whether there were differences in the quality of life with the two procedures. Researchers measured not only overall quality of life but also the impact of a patient’s heart disease on symptoms, physical limitations, pain, vitality and other factors. In addition, they collected economic data throughout the study on cardiovascular procedures, hospitalizations, outpatient testing, physician visits and medications.
They found that both stenting and CABG improved the overall quality of life over one year of follow-up, although chest pain relief was slightly better with CABG. Under the U.S. healthcare system, surgery was initially about
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