EXCEL Substudy Compares Quality-of-Life Outcomes in Left Main Disease Treated With PCI Versus CABG

October 30, 2017—Results from the EXCEL trial comparing the quality of life (QOL) of patients with left main coronary artery disease (LMCAD) receiving percutaneous coronary intervention (PCI) versus coronary artery bypass graft surgery (CABG) found significant and similar QOL improvement at 3 years, although a greater benefit was observed with PCI at 1 month. The data were presented at TCT 2017, the 29^th annual Transcatheter Cardiovascular Therapeutics scientific symposium held October 30 to November 2 in Denver, Colorado. The study was published simultaneously online by Suzanne J. Baron, MD, et al in Journal of the American College of Cardiology.

The EXCEL trial randomized patients with LMCAD of low to intermediate complexity to undergo revascularization by PCI with a second-generation everolimus-eluting stent or CABG.

Originally presented at TCT 2016, EXCEL demonstrated rates of death, stroke, and myocardial infarction that were similar with both PCI and CABG at a median of 3 years. However, the timing of clinical events and rates of repeat revascularization differed between the two groups. Those findings were published by Gregg W. Stone, MD, et al in The New England Journal of Medicine (2016;375:2223–2235).

The QOL substudy was composed of 1,788 of the 1,905 patients with LMCAD who were randomized to undergo CABG or PCI in the EXCEL trial. QOL was assessed at baseline and 1, 12, and 36 months using the Seattle Angina Questionnaire, the SF-12, the Rose Dyspnea Scale, the Patient Health Questionnaire-8, and the EQ-5D. Differences between PCI and CABG were assessed using longitudinal random-effect growth curve models.

As summarized in the 2017 TCT announcement, both disease-specific and generic health status measures in the PCI group improved significantly by 1 month. These improvements were largely sustained at 12 and 36 months. Patients assigned to CABG demonstrated only small improvements or even declines in health status on several scales (especially measures of physical limitation) at 1 month. However, by 12 and 36 months, health status had improved significantly across all scales in the CABG group to levels commensurate with the PCI group. In contrast to previous studies of PCI versus CABG, there was no evidence of a preferential benefit of CABG in any patient subgroups.

In the TCT press release, Dr. Baron commented, “Among patients with LMCAD with low or intermediate coronary artery disease complexity, PCI using a second-generation everolimus-eluting stent and CABG result in substantial and similar quality of life improvement through 36 months, with a greater early benefit observed with PCI. Taken together with the 3-year clinical data from EXCEL, these results suggest that PCI and CABG provide comparable intermediate-term outcomes for appropriately selected patients. Further studies are needed to evaluate the durability of health-status benefits with PCI compared with CABG beyond 3 years in patients with LMCAD.” Dr. Baron is from Saint Luke's Mid America Heart Institute in Kansas City, Missouri.