Percutaneous coronary intervention versus coronary artery bypass grafting for unprotected left main stenosis: 10-year final results from the randomised, open-label, non-inferiority NOBLE trial.

We aim to provide long-term outcome data comparing PCI with newer generation drug-eluting stents and CABG, which are scarce.

我们的目标是提供长期的结果数据，比较新一代药物洗脱支架的经皮冠状动脉介入治疗（PCI）与冠状动脉旁路移植术（CABG），这类数据目前较为稀缺。

Methods

This previously published, prospective, randomised, open-label, non-inferiority trial enrolled patients with unprotected left main coronary artery stenosis at 36 hospitals in Denmark, Estonia, Finland, Germany, Latvia, Lithuania, Norway, Sweden, and the UK.

这项先前发表的前瞻性、随机、开放标签、非劣效试验，在丹麦、爱沙尼亚、芬兰、德国、拉脱维亚、立陶宛、挪威、瑞典和英国的36家医院招募了无保护左主干冠状动脉狭窄的患者。

Eligibility was determined by a multidisciplinary heart team and defined by clinical criteria (chronic or acute coronary syndrome and a life expectancy of >1 year) and angiographic criteria (left main coronary artery diameter stenosis ≥50% or fractional flow reserve ≤0·80 in the left main ostium, mid-shaft, or bifurcation).

资格由多学科心脏团队确定，并根据临床标准（慢性或急性冠状动脉综合征以及预期寿命>1年）和血管造影标准（左主干冠状动脉直径狭窄≥50%或左主干开口、中段或分叉处的分数流量储备≤0.80）定义。

Patients with ST elevation myocardial infarction within 24 h or considered at too high risk for CABG or PCI were excluded.

在ST段抬高型心肌梗死发生后24小时内或被认为冠状动脉旁路移植术(CABG)或经皮冠状动脉介入治疗(PCI)风险过高的患者被排除在外。

Patients with angiographically confirmed significant left main coronary artery disease were randomly assigned (1:1) to PCI or CABG using an online system and stratified by site, sex, distal left main coronary artery bifurcation lesions, and diabetes.

通过血管造影确认有显著左主冠状动脉疾病的患者被随机分配(1:1)到PCI或CABG，使用在线系统，并根据地点、性别、远端左主冠状动脉分叉病变和糖尿病进行分层。

The primary outcome was the difference in 10-year all-cause mortality in the intention-to-treat(ITT) population, which was analysed using Kaplan-Meier estimates and unadjusted Cox regression.

主要结果是意向治疗（ITT）人群中10年全因死亡率的差异，使用Kaplan-Meier估计和未调整的Cox回归进行分析。

Patients were censored at the date of death, emigration, withdrawal, or loss to follow-up.

患者在死亡、移居、撤回或失访的日期被截断。

Variation in all-cause mortality was assessed in prespecified subgroups.

在预先设定的亚组中评估了全因死亡率的变化。

The trial is registered with ClinicalTrials.gov, NCT01496651 (active, not recruiting).

该试验已在ClinicalTrials.gov上注册，注册号为NCT01496651（活动状态，未招募）。

Results

From Dec 9, 2008, to Jan 21, 2015, 1201 patients were randomly assigned to PCI (n=598) or CABG (n=603). 17 patients were lost to follow-up before 1 year. 592 patients in each group were included in the ITT population.

2008年12月9日至2015年1月21日期间，共有1201名患者被随机分配至经皮冠状动脉介入治疗（PCI，n=598）组或冠状动脉旁路移植术（CABG，n=603）组。在随访1年之前，有17名患者失访。每组各有592名患者被纳入意向治疗（ITT）人群。

Mean age was 66·2 years (SD 9·9) in the PCI group and 66·2 years (9·4) in the CABG group. 256 (22%) of 1184 participants were female and 928 (78%) were male.

PCI组患者的平均年龄为66.2岁（标准差9.9），CABG组患者的平均年龄为66.2岁（标准差9.4）。在1184名参与者中，有256名（22%）为女性，928名（78%）为男性。

There was no difference in all-cause mortality at 10 years (136 [23%] of 592 in the PCI group and 145 [25%] of 592 in the CABG group; hazard ratio0·93 [95% CI 0·74-1·18]; p=0·56).

在10年的全因死亡率上没有差异（PCI组592人中有136人[23%]，CABG组592人中有145人[25%]；风险比为0.93[95%置信区间0.74-1.18]；p=0.56）。

No significant difference in all-cause mortality with SYNTAX score was identified.

使用SYNTAX评分并未发现全因死亡率有显著差异。

interpretation

There was no significant difference in all-cause mortality at 10 years between PCI and CABG for patients with unprotected left main coronary artery disease and no additional complex lesions, indicating that PCI is equally as safe as CABG in patients eligible for both treatments.

在未受保护的左主干冠状动脉疾病患者中，对于没有额外复杂病变的患者，10年全因死亡率在经皮冠状动脉介入治疗（PCI）和冠状动脉旁路移植术（CABG）之间没有显著差异，表明在适合两种治疗的患者中，PCI与CABG一样安全。

These results will aid heart teams in developing an individualised patient-centred strategy.

这些结果将有助于心脏团队制定个性化的以患者为中心的策略。

funding

Biosensors and Aarhus University Hospital.

生物传感器和奥胡斯大学医院。