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

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.

Carotid artery disease and stroke during coronary artery bypass surgery.

Stroke is a devastating complication during coronary artery bypass grafting. Screening may identify patients at highest risk. Surgical timing, sequence strategies and carotid stenting remain unresolved. Selective use of techniques could prevent adverse neurological sequelae while achieving complete myocardial revascularization.

Additive and logistic EuroSCORE performance in high risk patients.

We compared the performances of the additive and logistic EuroSCORE in predicting mortality in high-risk cardiac surgical patients, at a single institution. Both models were applied to 6535 patients, operated on at the Western Infirmary, Glasgow from March 1994 to August 2004. Calibration and discrimination were assessed using the Hosmer-Lemeshow [HL] Chi-square test and areas under the ROC curve. Overall mortality was 2.95%. Predicted mortalities were 4.1% [additive] and 5.2% [logistic]. Actual mortality was 0.6% in the low risk (additive EuroSCORE 1-2), 2.1% in the medium risk (EuroSCORE 3-5) and 7% in the high-risk groups (EuroSCORE 6 plus). Actual mortality increased beyond a predicted risk of 8-10%. At the low risks both systems slightly over-estimated mortality, with the logistic EuroSCORE being more accurate. At EuroSCOREs between 10-20, the additive EuroSCORE under-estimated risk, while the logistic EuroSCORE over-estimated mortality. Both systems were inaccurate at high risk. The HL statistics were 11.15 [P<0.64] for the additive and 37.78 [P<0.47] for the logistic models. ROC curve areas were 0.749+/-0.04 [additive] and 0.746+/-0.03 [logistic]. The additive EuroSCORE model remains a simple system for cardiac risk assessment. The logistic EuroSCORE was not more accurate even in high-risk patients.