Ten Year Survival after Coronary Artery Bypass Grafting versus Percutaneous Coronary Intervention: The SYNTAX Extended Survival (SYNTAXES) Study

Objectives: Ten-year survival outcomes from contemporaneous randomized trials comparing percutaneous coronary intervention (PCI) with drug eluting stents and coronary artery bypass grafting (CABG) in patients with de novo three vessel (3VD) or left main coronary artery disease (LMCAD) have not been reported.

Methods: The randomized synergy between PCI with TAXUS and cardiac surgery (SYNTAX) trial reported comparable survival rates between PCI with paclitaxel-eluting stents and CABG at 5 years. Therefore, the SYNTAX extended survival study (SYNTAXES) aims to determine 10-year survival in the SYNTAX randomized patients (n = 1,800; CABG = 897, PCI = 903). Follow-up was performed in accordance with local law and regulations of each of the currently 76-participating institutions. Cumulative time-to-death is estimated by Kaplan–Meier analysis and compared with log-rank tests. Hazard ratios (HR) with 95% confidence intervals (CI), of CABG versus PCI, are established by Cox’s proportional hazard models. Prespecified subgroup analyses of CABG versus PCI are performed in cohorts of patients with three vessel disease, left main disease, in patients with and without medically treated diabetes and according to SYNTAX scores.

Results: From March, 2005, to April, 2007, 1,800 patients were randomly assigned to the PCI (n = 903) or CABG (n = 897) group. Vital status information at 10 years was complete for 841 (93%) patients in the PCI group and 848 (95%) patients in the CABG group. At 10 years, 244 (27%) patients had died after PCI and 211 (24%) after CABG (HR = 1.17 [95% CI: 0.97–1.41], p = 0.092). Among patients with three-vessel disease, 151 (28%) of 546 had died after PCI versus 113 (21%) of 549 after CABG (HR = 1.41 [95% CI: 1.10–1.80]), and among patients with left main coronary artery disease, 93 (26%) of 357 had died after PCI versus 98 (28%) of 348 after CABG (0.90 [0.68–1.20], p for interaction = 0.019). There was no treatment-by-subgroup interaction with diabetes (p for interaction = 0.66) and no linear trend across SYNTAX score tertiles (p = 0.30).

Conclusion: At 10 years, no significant difference existed in all-cause death between PCI using first-generation paclitaxel-eluting stents and CABG. However, CABG provided a significant survival benefit in patients with three-vessel disease, but not in patients with left main coronary artery disease.