Lee Pil Hyung, Kang Se Hun, Han Seungbong, Ahn Jung-Min, Bae Jae Seok, Lee Cheol Hyun, Kang Soo-Jin, Lee Seung-Whan, Kim Young-Hak, Lee Cheol Whan, Park Seong-Wook, Park Duk-Woo, Park Seung-Jung
aDepartment of Cardiology, University of Ulsan College of Medicine, Asan Medical Center, Seoul bDepartment of Applied Statistics, Gachon University, Seongnam, Korea.
Coron Artery Dis. 2017 Dec;28(8):675-682. doi: 10.1097/MCA.0000000000000543.
The aim of this study was to determine how trial-based findings of EXCEL and NOBLE might be interpreted and generalizable in 'real-world' settings with comparison of data from the large-scaled, all-comer Interventional Research Incorporation Society-Left MAIN Revascularization (IRIS-MAIN) registry.
We compared baseline clinical and procedural characteristics and also determined how the relative treatment effect of percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) was different in EXCEL and NOBLE, compared with those of the multicenter, IRIS-MAIN registry (n=2481). The primary outcome for between-study comparison was a composite of death, myocardial infarction (MI), or stroke.
There were between-study differences in patient risk profiles (age, BMI, diabetes, and clinical presentation), lesion complexities, and procedural characteristics (stent type, the use of off-pump surgery, and radial artery); the proportion of diabetes and acute coronary syndrome was particularly lower in NOBLE than in other studies. Although there was interstudy heterogeneity for the protocol definition of MI, the risks for serious composite outcome of death, MI, or stroke were similar between PCI and CABG in EXCEL [hazard ratio (HR): 1.00; 95% confidence interval (CI): 0.79-1.26; P=0.98] and in the matched cohort of IRIS-MAIN (HR: 1.08; 95%CI: 0.85-1.38; P=0.53), whereas it was significantly higher after PCI than after CABG in NOBLE (HR: 1.47; 95%CI: 1.06-2.05; P=0.02), which was driven by more common MI and stroke after PCI.
In the comparison of a large-sized, all-comer registry, the EXCEL trial might represent better generalizability with respect to baseline characteristics and observed clinical outcomes compared with the NOBLE trial.
本研究旨在通过比较大规模、所有患者均可纳入的介入研究协会-左主干血运重建（IRIS-MAIN）注册研究的数据，确定EXCEL和NOBLE基于试验的研究结果在“现实世界”环境中如何解释以及是否具有普遍性。
我们比较了基线临床和手术特征，并确定了与多中心IRIS-MAIN注册研究（n=2481）相比，经皮冠状动脉介入治疗（PCI）和冠状动脉旁路移植术（CABG）在EXCEL和NOBLE中的相对治疗效果有何不同。研究间比较的主要结局是死亡、心肌梗死（MI）或中风的复合结局。
研究间在患者风险特征（年龄、体重指数、糖尿病和临床表现）、病变复杂性和手术特征（支架类型、非体外循环手术的使用和桡动脉）方面存在差异；NOBLE中糖尿病和急性冠状动脉综合征的比例尤其低于其他研究。尽管MI的方案定义存在研究间异质性，但EXCEL中PCI和CABG之间死亡、MI或中风的严重复合结局风险相似[风险比（HR）：1.00；95%置信区间（CI）：0.79-1.26；P=0.98]，在IRIS-MAIN的匹配队列中也相似（HR：1.08；95%CI：0.85-1.38；P=0.53），而在NOBLE中，PCI后该风险显著高于CABG后（HR：1.47；95%CI：1.06-2.05；P=0.02），这是由PCI后更常见的MI和中风所致。
在大型、所有患者均可纳入的注册研究比较中，与NOBLE试验相比，EXCEL试验在基线特征和观察到的临床结局方面可能具有更好的普遍性。
