Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes…

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 31 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 135 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 49 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 158 [95% CI 124201]); 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=00002). All-cause mortality was estimated in 9% after PCI versus 9% after CABG (HR 108 [95% CI 074159]; p=068); non-procedural myocardial infarction was estimated in 8% after PCI versus 3% after CABG (HR 299 [95% CI 166539]; p=00002); and repeat revascularisation was estimated in 17% after PCI versus 10% after CABG (HR 173 [95% CI 125240]; p=00009).

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.

Biosensors.

Left main coronary artery disease: secular trends in patient characteristics, treatments, and outcomes.

J Am Coll Cardiol. 2016; 68: 1233-1246

Randomized trial of stents versus bypass surgery for left main coronary artery disease: 5-year outcomes of the PRECOMBAT study.

J Am Coll Cardiol. 2015; 65: 2198-2206

Coronary artery bypass graft surgery versus percutaneous coronary intervention in patients with three-vessel disease and left main coronary disease: 5-year follow-up of the randomised, clinical SYNTAX trial.

Lancet. 2013; 381: 629-638

Five-year outcomes in patients with left main disease treated with either percutaneous coronary intervention or coronary artery bypass grafting in the synergy between percutaneous coronary intervention with taxus and cardiac surgery trial.

Circulation. 2014; 129: 2388-2394

Percutaneous coronary intervention versus coronary artery bypass grafting in patients with three-vessel or left main coronary artery disease: 10-year follow-up of the multicentre randomised controlled SYNTAX trial.

Lancet. 2019; 394: 1325-1334

Five-year outcomes after PCI or CABG for left main coronary disease.

N Engl J Med. 2019; 381: 1820-1830

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

Lancet. 2016; 388: 2743-2752

2018 ESC/EACTS Guidelines on myocardial revascularization.

Eur Heart J. 2019; 40: 87-165

Clinical end points in coronary stent trials: a case for standardized definitions.

Circulation. 2007; 115: 2344-2351

Standardized end point definitions for coronary intervention trials: the Academic Research Consortium-2 consensus document.

Circulation. 2018; 137: 2635-2650

Everolimus-eluting stents or bypass surgery for left main coronary artery disease.

N Engl J Med. 2016; 375: 2223-2235

Mortality after coronary artery bypass grafting versus percutaneous coronary intervention with stenting for coronary artery disease: a pooled analysis of individual patient data.

Lancet. 2018; 391: 939-948

Stroke rates following surgical versus percutaneous coronary revascularization.

J Am Coll Cardiol. 2018; 72: 386-398

Outcomes of left main revascularization in patients with acute coronary syndromes and stable ischemic heart disease: analysis from the EXCEL trial.

Am Heart J. 2019; 214: 9-17

Relative spatial distributions of coronary artery bypass graft insertion and acute thrombosis: a model for protection from acute myocardial infarction.

Am Heart J. 2010; 160: 195-201

Bypass surgery or stenting for left main coronary artery disease in patients with diabetes.

J Am Coll Cardiol. 2019; 73: 1616-1628

Predicting adverse outcomes after myocardial infarction among patients with diabetes mellitus.

Circ Cardiovasc Qual Outcomes. 2016; 9: 372-379

Everolimus-eluting stents or bypass surgery for left main coronary disease.

N Engl J Med. 2017; 376: 1088-1089

Why NOBLE and EXCEL are consistent with each other and with previous trials.

Circulation. 2017; 135: 822-824

Incidence, characteristics, predictors, and outcomes of repeat revascularization after percutaneous coronary intervention and coronary artery bypass grafting: the SYNTAX trial at 5 years.

JACC Cardiovasc Interv. 2016; 9: 2493-2507

Fourth universal definition of myocardial infarction (2018).

J Am Coll Cardiol. 2018; 72: 2231-2264

Impact of large periprocedural myocardial infarction on mortality after percutaneous coronary intervention and coronary artery bypass grafting for left main disease: an analysis from the EXCEL trial.

Eur Heart J. 2019; 40: 1930-1941

Rational and design of the European randomized optical coherence tomography optimized bifurcation event reduction trial (OCTOBER).

Am Heart J. 2018; 205: 97-109

Intravascular ultrasound in the evaluation and treatment of left main coronary artery disease: a consensus statement from the European Bifurcation Club.

EuroIntervention. 2018; 14: e467-e474

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Percutaneous coronary angioplasty versus coronary artery bypass grafting in the treatment of unprotected left main stenosis: updated 5-year outcomes...