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》。
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
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.
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.
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).
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.