Trade-offs between short- and long-term outcomes for PCI and CABG in left main coronary artery disease (EXCEL)

Reference

Stone GW, Kappetein AP, Sabik JF, et al, for the EXCEL Trial Investigators. Five-year outcomes after PCI or CABG for left main coronary disease. N Engl J Med 2019;381(19):1820-1830. Thuijs DJFM, Kappetein AP, Serruys PW, et al, for the SYNTAX Extended Survival Investigators. 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(10206):1325-1334.

Synopsis

In this multicenter international trial, investigators randomized 1905 patients with left main coronary artery disease with low or intermediate anatomical complexity to receive either PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). The 2 groups were well-balanced at baseline: Approximately 80% of the study population was male and 30% had diabetes. The original trial was powered to show noninferiority of PCI to CABG at 3 years for the primary outcome of all-cause death, stroke, or MI. In the current study, the 5-year outcomes were reported. Follow-up data at 5 years were available for more than 90% in each group. Analysis was by intention to treat. Overall, there was no significant difference in the primary outcome, with events occurring in 22.0% of patients in the PCI group and 19.2% of patients in the CABG group at 5 years (difference 2.8; 95% CI -0.9 to 6.5; P = .13). There were more deaths in the PCI group (13.0% vs 9.9%; odds ratio [OR] 1.38; 1.03 - 1.85), but the rates of strokes and MIs were similar. Ischemia-driven revascularization also occurred at a higher rate in the PCI group (16.9% vs 10.0%; OR 1.84; 1.39 - 2.44). Notably, the HR of PCI compared with CABG changed in 3 specified time periods: at 0 to 30 days the HR was 0.61 (0.42 - 0.88); at 30 days to 1 year, the HR was 1.07 (0.68 - 1.70); and at 1 year to 5 years, the HR was 1.61 (1.23 - 2.12). This suggests an early benefit to PCI with reduced periprocedural risk, specifically fewer early MIs, but a greater number of events during the 1-year to 5-year period, including deaths, MIs, and the need for revascularization. Recently published 10-year outcomes from another trial (SYNTAXES) showed no treatment difference in patients with left main disease when comparing PCI with CABG, but did show mortality benefit with CABG among patients with 3-vessel disease and high-complexity coronary disease.