Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial
Percutaneous coronary angioplasty versus coronary artery bypass grafting in treatment of unprotected left main stenosis (NOBLE): a prospective, randomised, open-label, non-inferiority trial
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DOI：
10.1016/s0140-6736(16)32052-9
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发表时间：
2016-12-03
期刊：
影响因子：
168.9
通讯作者：
Christiansen, Evald H.
中科院分区：
文献类型：
--
作者：
Makikallio, Timo;Holm, Niels R.;Christiansen, Evald H.
背景冠状动脉旁路移植术(CABG)是左主干病变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)在这一适应症中的应用正在增加。目的比较经皮冠状动脉介入治疗和冠状动脉旁路移植术治疗左主干病变的疗效。方法在这项前瞻性、随机、开放、非劣势试验中，在北欧的36个中心入选左主干病变患者，随机1：1接受经皮冠状动脉介入治疗或冠状动脉旁路移植术。符合条件的患者有稳定型心绞痛、不稳定型心绞痛或非ST段抬高的心肌梗死。排除标准为24小时内ST段抬高的心肌梗死，认为冠状动脉搭桥术或经皮冠状动脉介入治疗的风险太高，或预期生存时间少于1年。主要终点是主要不良心脏或脑血管事件(MACCE)，包括全因死亡率、非程序性心肌梗死、任何重复的冠状动脉血管重建术和中风。冠状动脉搭桥术的非劣势要求95%可信区间的下限不超过风险比(HR)1。35岁，经过长达5年的随访。如果没有特别说明，在分析中使用了意向治疗原则。这项试验注册了ClinicalTrials.gov标识符，编号为NCT01496651。在2008年12月9日至2015年1月21日期间，1201名患者被随机分配，598名患者接受经皮冠状动脉介入治疗，603名患者接受冠脉搭桥术，每组592人进入意向治疗分析。Kaplan-Meier对MACCE的5年估计为：冠状动脉介入治疗(121例)为29%，冠脉搭桥术(81例)为19%，HR为1。48(95%可信区间1。11-1。96)，超过非劣势极限，冠状动脉旁路移植术明显优于经皮冠状动脉介入术(p=0。0066)。治疗前的估计为28%，而不是19%(1。55，1。18-2。04，p=0。0015)。比较经皮冠状动脉介入治疗和冠脉搭桥术，5年估计为12%和9%(1。07，0。67比1。72，p=0。77)全因死亡率为7%，而不是2%(2。88，1。40比5。90，p=0。0040)对于非程序性心肌梗死，16%对10%(1。50，1。04-2。17，p=0。032)，5%与2%(2%)。25，0。93-5。48，p=0。解释：本研究结果提示，冠状动脉旁路移植术治疗左主干冠状动脉病变可能优于经皮冠状动脉介入术。
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.