经皮冠状动脉介入治疗与冠状动脉旁路移植术治疗无保护左主干狭窄（NOBLE）：一项前瞻性、随机、开放标签、非劣效性试验。

Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial.

机构信息

Department of Cardiology, Oulu University Hospital, Oulu, Finland.

Department of Cardiology, Aarhus University Hospital, Skejby, Aarhus, Denmark.

出版信息

Lancet. 2016 Dec 3;388(10061):2743-2752. doi: 10.1016/S0140-6736(16)32052-9. Epub 2016 Oct 31.

DOI:10.1016/S0140-6736(16)32052-9

PMID:27810312

Abstract

BACKGROUND

Coronary artery bypass grafting (CABG) is the standard treatment for revascularisation in patients with left main coronary artery disease, but use of percutaneous coronary intervention (PCI) for this indication is increasing. We aimed to compare PCI and CABG for treatment of left main coronary artery disease.

METHODS

In this prospective, randomised, open-label, non-inferiority trial, patients with left main coronary artery disease were enrolled in 36 centres in northern Europe and randomised 1:1 to treatment with PCI or CABG. Eligible patients had stable angina pectoris, unstable angina pectoris, or non-ST-elevation myocardial infarction. Exclusion criteria were ST-elevation myocardial infarction within 24 h, being considered too high risk for CABG or PCI, or expected survival of less than 1 year. The primary endpoint was major adverse cardiac or cerebrovascular events (MACCE), a composite of all-cause mortality, non-procedural myocardial infarction, any repeat coronary revascularisation, and stroke. Non-inferiority of PCI to CABG required the lower end of the 95% CI not to exceed a hazard ratio (HR) of 1·35 after up to 5 years of follow-up. The intention-to-treat principle was used in the analysis if not specified otherwise. This trial is registered with ClinicalTrials.gov identifier, number NCT01496651.

FINDINGS

Between Dec 9, 2008, and Jan 21, 2015, 1201 patients were randomly assigned, 598 to PCI and 603 to CABG, and 592 in each group entered analysis by intention to treat. Kaplan-Meier 5 year estimates of MACCE were 29% for PCI (121 events) and 19% for CABG (81 events), HR 1·48 (95% CI 1·11-1·96), exceeding the limit for non-inferiority, and CABG was significantly better than PCI (p=0·0066). As-treated estimates were 28% versus 19% (1·55, 1·18-2·04, p=0·0015). Comparing PCI with CABG, 5 year estimates were 12% versus 9% (1·07, 0·67-1·72, p=0·77) for all-cause mortality, 7% versus 2% (2·88, 1·40-5·90, p=0·0040) for non-procedural myocardial infarction, 16% versus 10% (1·50, 1·04-2·17, p=0·032) for any revascularisation, and 5% versus 2% (2·25, 0·93-5·48, p=0·073) for stroke.

INTERPRETATION

The findings of this study suggest that CABG might be better than PCI for treatment of left main stem coronary artery disease.

FUNDING

Biosensors, Aarhus University Hospital, and participating sites.

摘要

背景

冠状动脉旁路移植术（CABG）是治疗左主干冠状动脉疾病患者血运重建的标准治疗方法，但经皮冠状动脉介入治疗（PCI）在该适应证中的应用正在增加。我们旨在比较 PCI 和 CABG 治疗左主干冠状动脉疾病。

方法

在这项前瞻性、随机、开放标签、非劣效性试验中，来自北欧的 36 个中心招募了患有左主干冠状动脉疾病的患者，并按 1:1 的比例随机分配至接受 PCI 或 CABG 治疗。纳入的患者有稳定型心绞痛、不稳定型心绞痛或非 ST 段抬高型心肌梗死。排除标准为发病 24 小时内的 ST 段抬高型心肌梗死、被认为对 CABG 或 PCI 风险过高、或预计生存时间少于 1 年。主要不良心脏或脑血管事件（MACCE）是所有原因死亡、非手术性心肌梗死、任何再次冠状动脉血运重建和中风的复合终点，是本研究的主要终点。要求 PCI 不劣于 CABG，即在随访 5 年期间，95%CI 的下限不超过 1.35 的风险比（HR）。如果没有特别说明，将采用意向治疗原则进行分析。本试验在 ClinicalTrials.gov 注册号为 NCT01496651。

结果

2008 年 12 月 9 日至 2015 年 1 月 21 日，共随机分配了 1201 例患者，598 例接受 PCI，603 例接受 CABG，每组各有 592 例患者按意向治疗进行分析。PCI 的 5 年 MACCE 发生率为 29%（121 例事件），CABG 的发生率为 19%（81 例事件），HR 为 1.48（95%CI 为 1.11-1.96），超过了非劣效性的界限，CABG 明显优于 PCI（p=0.0066）。按实际治疗情况分析，MACCE 的发生率分别为 28%和 19%（1.55，1.18-2.04，p=0.0015）。与 CABG 相比，PCI 的 5 年 MACCE 发生率分别为 12%和 9%（1.07，0.67-1.72，p=0.77），全因死亡率；7%和 2%（2.88，1.40-5.90，p=0.0040），非手术性心肌梗死；16%和 10%（1.50，1.04-2.17，p=0.032），任何再次血运重建；5%和 2%（2.25，0.93-5.48，p=0.073），中风。