ArticlesCoronary 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
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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