Elsevier

The Lancet

Volume 381, Issue 9867, 23 February–1 March 2013, Pages 629-638
The Lancet

Articles
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

https://doi.org/10.1016/S0140-6736(13)60141-5Get rights and content

Summary

Background

We report the 5-year results of the SYNTAX trial, which compared coronary artery bypass graft surgery (CABG) with percutaneous coronary intervention (PCI) for the treatment of patients with left main coronary disease or three-vessel disease, to confirm findings at 1 and 3 years.

Methods

The randomised, clinical SYNTAX trial with nested registries took place in 85 centres in the USA and Europe. A cardiac surgeon and interventional cardiologist at each centre assessed consecutive patients with de-novo three-vessel disease or left main coronary disease to determine suitability for study treatments. Eligible patients suitable for either treatment were randomly assigned (1:1) by an interactive voice response system to either PCI with a first-generation paclitaxel-eluting stent or to CABG. Patients suitable for only one treatment option were entered into either the PCI-only or CABG-only registries. We analysed a composite rate of major adverse cardiac and cerebrovascular events (MACCE) at 5-year follow-up by Kaplan-Meier analysis on an intention-to-treat basis. This study is registered with ClinicalTrials.gov, number NCT00114972.

Findings

1800 patients were randomly assigned to CABG (n=897) or PCI (n=903). More patients who were assigned to CABG withdrew consent than did those assigned to PCI (50 vs 11). After 5 years’ follow-up, Kaplan-Meier estimates of MACCE were 26·9% in the CABG group and 37·3% in the PCI group (p<0·0001). Estimates of myocardial infarction (3·8% in the CABG group vs 9·7% in the PCI group; p<0·0001) and repeat revascularisation (13·7% vs 25·9%; p<0·0001) were significantly increased with PCI versus CABG. All-cause death (11·4% in the CABG group vs 13·9% in the PCI group; p=0·10) and stroke (3·7% vs 2·4%; p=0·09) were not significantly different between groups. 28·6% of patients in the CABG group with low SYNTAX scores had MACCE versus 32·1% of patients in the PCI group (p=0·43) and 31·0% in the CABG group with left main coronary disease had MACCE versus 36·9% in the PCI group (p=0·12); however, in patients with intermediate or high SYNTAX scores, MACCE was significantly increased with PCI (intermediate score, 25·8% of the CABG group vs 36·0% of the PCI group; p=0·008; high score, 26·8% vs 44·0%; p<0·0001).

Interpretation

CABG should remain the standard of care for patients with complex lesions (high or intermediate SYNTAX scores). For patients with less complex disease (low SYNTAX scores) or left main coronary disease (low or intermediate SYNTAX scores), PCI is an acceptable alternative. All patients with complex multivessel coronary artery disease should be reviewed and discussed by both a cardiac surgeon and interventional cardiologist to reach consensus on optimum treatment.

Funding

Boston Scientific.

Introduction

Coronary artery bypass graft surgery (CABG) has been the standard of care for revascularisation of patients with complex coronary artery disease since its introduction in 1968.1 When percutaneous coronary intervention (PCI) was introduced in 1977,2 it was thought to be appropriate only for patients with single-vessel disease, but as operator ability and device technologies have advanced, the use of PCI has expanded to treat patients with increasingly complex disease, such as multivessel and left main coronary disease.

The optimum method for revascularisation of these patients has been a matter of debate, with many published trials comparing outcomes of CABG and PCI with drug-eluting stents (DES).3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13 Most of these trials have been limited by non-randomised patient selection, inclusion of less complex disease, or insufficient statistical power. The SYNergy between percutaneous coronary intervention with TAXus and cardiac surgery (SYNTAX) trial14 assessed the optimum revascularisation treatment for patients with de-novo left main coronary disease or three-vessel disease (or both), by randomly assigning patients to either PCI with a first-generation paclitaxel-eluting stent or CABG. For the primary endpoint of major adverse cardiac and cerebrovascular events (MACCE) at 1 year, PCI did not meet the goal of non-inferiority compared with CABG, because the PCI group had a significantly higher rate of repeat revascularisation than did the CABG group.15 Rates of death and myocardial infarction were similar between the two groups, and stroke was significantly increased in the CABG group compared with the PCI group. At 3 years, rates of MACCE, myocardial infarction, and repeat revascularisation were significantly higher in the PCI group than in the CABG group, whereas rates of the composite safety endpoint of death or stroke or myocardial infarction, and stroke alone, were not significantly different between treatment groups.16

Here we present the final results of the SYNTAX trial after 5 years of follow-up, with the aim to confirm the 1-year and 3-year findings.

Section snippets

Study design and patients

The design and methods for this trial have been previously described14, 15, 16 and are briefly summarised here. SYNTAX was a randomised clinical trial with nested registries that took place in 85 centres in the USA and Europe. A heart team, consisting of a cardiac surgeon and interventional cardiologist, at each centre screened consecutive patients with de-novo three-vessel disease or left main coronary disease or both. If regarded as equally suitable for revascularisation with either

Results

Of 1800 patients enrolled in the randomised cohort, 897 were assigned to CABG and 903 to PCI. 805 (89·7%) patients in the CABG group and 871 (96·5%) in the PCI group completed 5 years’ follow-up (figure 1). After randomisation, more patients who were assigned CABG withdrew consent than did those assigned to PCI (50 patients in the CABG group vs 11 in the PCI group); of those who withdrew consent, 21 patients assigned to CABG and two assigned to PCI did so before receiving treatment.

Patient

Discussion

Results of this final 5-year analysis of the SYNTAX trial show that CABG remains the standard of care for patients with complex coronary lesions, driven by favourable rates of MACCE, cardiac death, myocardial infarction, and repeat revascularisation in the CABG group compared with the PCI group. Results from SYNTAX have been previously reported at the primary endpoint of 1 years’ and at 3 years’ follow-up.15, 16 The new, 5-year findings show the continuing separation in event rates between the

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