丹麦奥胡斯大学医院Evald Høj Christiansen研究团队近日取得一项新成果。他们的最新研究比较了经皮冠状动脉成形术与冠状动脉旁路移植术治疗无保护左主干狭窄的疗效。该研究成果2019年12月23日在线发表于国际一流学术期刊《柳叶刀》。

经皮冠状动脉介入治疗（PCI）越来越多地用于左冠状动脉主干疾病患者的血运重建，取代了常规的冠状动脉旁路移植术（CABG）。NOBLE试验旨在评价PCI治疗左主干病变是否优于CABG，并报告中位随访3.1年后的结果。研究组现在报告最新的随访5年的试验结果。

这项前瞻性、随机、开放性、非劣效性的NOBLE试验在北欧9个国家的36家医院进行。2008年12月9日至2015年1月21日，研究组共招募了1201名左冠状动脉主干病变需要血运重建的患者，将其按1：1随机分组，其中598名接受PCI治疗，603名接受CABG治疗。心脑血管不良事件（MACCE）包括全因死亡、非手术性心肌梗死、重复血运重建和中风的综合结果。

每组有592名患者纳入最终分析。中位随访4.9年后，PCI组的K-M5年预测MACCE发生率为28%，CABG组为19%，不符合非劣效标准，CABG的疗效显著优于PCI。PCI组和CABG组的全因死亡率分别为9%和9%，非手术性心肌梗死发生率分别为8%和3%，重复血运重建率分别为17%和10%。

总之，在左主干病变患者的血运重建中，与CABG相比，PCI术后5年的临床疗效较差。两种手术后的死亡率相差不大，但PCI术后的患者非手术性心肌梗死和重复血运重建的发生率较高。

附：英文原文

Title: Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes from the randomised, non-inferiority NOBLE trial

Author: Niels R Holm, Timo Mkikallio, M Mitchell Lindsay, Mark S Spence, Andrejs Erglis, Ian B A Menown, Thor Trovik, Thomas Kellerth, Gintaras Kalinauskas, Lone Juul Hune Mogensen, Per H Nielsen, Matti Niemel, Jens F Lassen, Keith Oldroyd, Geoffrey Berg, Peteris Stradins, Simon J Walsh, Alastair N J Graham, Petter C Endresen, Ole Frbert, Uday Trivedi, Vesa Anttila, David Hildick-Smith, Leif Thuesen, Evald H Christiansen, Niels R Holm, Timo Mkikallio, Mitchell Lindsay, Mark S Spence, Andrejs Erglis, Ian B A Menown, Thor Trovik, Markku Eskola, Hannu Romppanen, Tholmas Kellerth, Lisette O Jensen, Gintaras Kalinauskas, Rikard B A Linder, Markku Pentikainen, Anders Hervold, Adrian Banning, Azfar Zaman, James Cotton, Erlend Eriksen, Sulev Margus, Lone J H Mogensen, Per H Nielsen, Matti Niemel, Kari Kervinen, Jens F Lassen, Keith Oldroyd, Geoff Berg, Simon J Walsh, Colm G Hanratty, Indulis Kumsars, Peteris Stradins, Terje K Steigen, Ole Frbert, Alastair NJ Graham, Petter C Endresen, Matthias Corbascio, Olli Kajander, Uday Trivedi, Juha Hartikainen, Ves Anttila, David Hildick-Smith, Leif Thuesen, Evald H Christiansen

Issue&Volume: December 23, 2019

Abstract:

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.

DOI: 10.1016/S0140-6736(19)32972-1

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(19)32972-1/fulltext