Hlatky Mark A, Boothroyd Derek B, Bravata Dena M, Boersma Eric, Booth Jean, Brooks Maria M, Carrié Didier, Clayton Tim C, Danchin Nicolas, Flather Marcus, Hamm Christian W, Hueb Whady A, Kähler Jan, Kelsey Sheryl F, King Spencer B, Kosinski Andrzej S, Lopes Neuza, McDonald Kathryn M, Rodriguez Alfredo, Serruys Patrick, Sigwart Ulrich, Stables Rodney H, Owens Douglas K, Pocock Stuart J
Stanford University School of Medicine, Stanford, CA, USA.
Lancet. 2009 Apr 4;373(9670):1190-7. doi: 10.1016/S0140-6736(09)60552-3. Epub 2009 Mar 19.
Coronary artery bypass graft (CABG) and percutaneous coronary intervention (PCI) are alternative treatments for multivessel coronary disease. Although the procedures have been compared in several randomised trials, their long-term effects on mortality in key clinical subgroups are uncertain. We undertook a collaborative analysis of data from randomised trials to assess whether the effects of the procedures on mortality are modified by patient characteristics.
We pooled individual patient data from ten randomised trials to compare the effectiveness of CABG with PCI according to patients' baseline clinical characteristics. We used stratified, random effects Cox proportional hazards models to test the effect on all-cause mortality of randomised treatment assignment and its interaction with clinical characteristics. All analyses were by intention to treat.
Ten participating trials provided data on 7812 patients. PCI was done with balloon angioplasty in six trials and with bare-metal stents in four trials. Over a median follow-up of 5.9 years (IQR 5.0-10.0), 575 (15%) of 3889 patients assigned to CABG died compared with 628 (16%) of 3923 patients assigned to PCI (hazard ratio [HR] 0.91, 95% CI 0.82-1.02; p=0.12). In patients with diabetes (CABG, n=615; PCI, n=618), mortality was substantially lower in the CABG group than in the PCI group (HR 0.70, 0.56-0.87); however, mortality was similar between groups in patients without diabetes (HR 0.98, 0.86-1.12; p=0.014 for interaction). Patient age modified the effect of treatment on mortality, with hazard ratios of 1.25 (0.94-1.66) in patients younger than 55 years, 0.90 (0.75-1.09) in patients aged 55-64 years, and 0.82 (0.70-0.97) in patients 65 years and older (p=0.002 for interaction). Treatment effect was not modified by the number of diseased vessels or other baseline characteristics.
Long-term mortality is similar after CABG and PCI in most patient subgroups with multivessel coronary artery disease, so choice of treatment should depend on patient preferences for other outcomes. CABG might be a better option for patients with diabetes and patients aged 65 years or older because we found mortality to be lower in these subgroups.
冠状动脉旁路移植术（CABG）和经皮冠状动脉介入治疗（PCI）是多支冠状动脉疾病的替代治疗方法。尽管在多项随机试验中对这两种手术进行了比较，但它们对关键临床亚组死亡率的长期影响尚不确定。我们对随机试验数据进行了协作分析，以评估手术对死亡率的影响是否因患者特征而改变。
我们汇总了来自10项随机试验的个体患者数据，根据患者的基线临床特征比较CABG与PCI的有效性。我们使用分层随机效应Cox比例风险模型来测试随机治疗分配对全因死亡率的影响及其与临床特征的相互作用。所有分析均按意向性治疗进行。
10项参与试验提供了7812例患者的数据。6项试验中PCI采用球囊血管成形术，4项试验中采用裸金属支架。在中位随访5.9年（四分位间距5.0 - 10.0）期间，3889例分配接受CABG的患者中有575例（15%）死亡，而3923例分配接受PCI的患者中有628例（16%）死亡（风险比[HR]0.91，95%CI 0.82 - 1.02；p = 0.12）。在糖尿病患者中（CABG组，n = 615；PCI组，n = 618），CABG组的死亡率显著低于PCI组（HR 0.70，0.56 - 0.87）；然而，在无糖尿病患者中，两组死亡率相似（HR 0.98，0.86 - 1.12；相互作用p = 0.014）。患者年龄改变了治疗对死亡率的影响，年龄小于55岁的患者风险比为1.25（0.94 - 1.66），55 - 64岁的患者为0.90（0.75 - 1.09），65岁及以上的患者为0.82（0.70 - 0.97）（相互作用p = 0.002）。治疗效果未因病变血管数量或其他基线特征而改变。
在大多数多支冠状动脉疾病患者亚组中，CABG和PCI后的长期死亡率相似，因此治疗选择应取决于患者对其他结局的偏好。对于糖尿病患者和65岁及以上的患者，CABG可能是更好的选择，因为我们发现这些亚组中的死亡率较低。
