BACKGROUND Percutaneous coronary intervention (PCI) is increasingly used in revascularisation of patients with left main coronary artery disease in place of the standard treatment, coronary artery bypass grafting (CABG). The NOBLE trial aimed to evaluate whether PCI was non-inferior to CABG in the treatment of left main coronary artery disease and reported outcomes after a median follow-up of 3·1 years. We now report updated 5-year outcomes of the trial. METHODS The prospective, randomised, open-label, non-inferiority NOBLE trial was done at 36 hospitals in nine northern European countries. Patients with left main coronary artery disease requiring revascularisation were enrolled and randomly assigned (1:1) to receive PCI or CABG. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, repeat revascularisation, and stroke. Non-inferiority of PCI to CABG was defined as the upper limit of the 95% CI of the hazard ratio (HR) not exceeding 1·35 after 275 MACCE had occurred. Secondary endpoints included all-cause mortality, non-procedural myocardial infarction, and repeat revascularisation. Outcomes were analysed in the intention-to-treat population. This trial is registered with ClinicalTrials.gov, NCT01496651. FINDINGS Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were enrolled and allocated to PCI (n=598) or CABG (n=603), with 17 subsequently lost to early follow-up. 592 patients in each group were included in this analysis. At a median of 4·9 years of follow-up, the predefined number of events was reached for adequate power to assess the primary endpoint. Kaplan-Meier 5-year estimates of MACCE were 28% (165 events) for PCI and 19% (110 events) for CABG (HR 1·58 [95% CI 1·24-2·01]); the HR exceeded the limit for non-inferiority of PCI compared to CABG. CABG was found to be superior to PCI for the primary composite endpoint (p=0·0002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 1·08 [95% CI 0·74-1·59]; p=0·68); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 2·99 [95% CI 1·66-5·39]; p=0·0002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 1·73 [95% CI 1·25-2·40]; p=0·0009). INTERPRETATION In revascularisation of left main coronary artery disease, PCI was associated with an inferior clinical outcome at 5 years compared with CABG. Mortality was similar after the two procedures but patients treated with PCI had higher rates of non-procedural myocardial infarction and repeat revascularisation. FUNDING Biosensors.

中文翻译：

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经皮冠状动脉成形术与冠状动脉搭桥术治疗无保护的左主干狭窄：随机，非劣效性NOBLE试验更新的5年结果。

背景技术经皮冠状动脉介入治疗（PCI）越来越多地用于左主干冠状动脉疾病患者的血运重建，以代替标准治疗，冠状动脉搭桥术（CABG）。这项NOBLE试验旨在评估PCI在左主干冠状动脉疾病治疗方面是否不劣于CABG，并报告了中位随访3·1年的结果。现在，我们报告该试验的5年更新结果。方法前瞻性，随机，开放标签，非劣效性NOBLE试验在北欧9个国家的36家医院进行。招募了需要进行血管重建的左主冠状动脉疾病患者，并随机分配（1：1）接受PCI或CABG。主要终点是主要的不良心脏或脑血管事件（MACCE），这是全因死亡率的综合结果，非程序性心肌梗塞，重复血运重建和中风。PCI相对于CABG的非劣效性定义为发生275 MACCE后危险比（HR）的95％CI的上限不超过1·35。次要终点包括全因死亡率，非程序性心肌梗塞和重复血运重建。分析意向治疗人群的结局。该试验已在ClinicalTrials.gov（NCT01496651）上注册。结果在2008年12月9日至2015年1月21日之间，共入组1201​​例患者，分配PCI（n = 598）或CABG（n = 603），随后有17例因早期随访而丢失。每组中有592例患者被纳入该分析。在平均4·9年的随访中，达到了预定义的事件数，以具有足够的能力评估主要终点。Kaplan-Meier对MACCE的5年估计值是PCI占28％（165个事件），CABG占19％（110个事件）（HR 1·58 [95％CI 1·24-2·01]）；与CABG相比，HR超过了PCI的非劣效性极限。发现CABG在主要复合终点方面优于PCI（p = 0·0002）。估计PCI后全因死亡率为9％，而CABG后为9％（HR 1·08 [95％CI 0·74-1·59]； p = 0·68）。非手术性心肌梗死估计在PCI后为8％，而在CABG后为3％（HR 2·99 [95％CI 1·66-5·39]； p = 0·0002）；PCI后的再次血运重建估计为17％，而CABG后为10％（HR 1·73 [95％CI 1·25-2·40]； p = 0·0009）。解释在左主冠状动脉疾病的血运重建中，与CABG相比，PCI在5年时的临床结局较差。两次手术后的死亡率相似，但接受PCI治疗的患者非手术性心肌梗塞和再次血运重建的发生率更高。资助生物传感器。