EXCEL: QoL Substudy Reports PCI, CABG Yield Similar Outcomes in Unprotected Left Main Disease
A prospective quality of life (QoL) substudy of EXCEL has shown that over 36 months both PCI and CABG were associated with significant improvements in QoL compared with baseline. The results were presented by Suzanne J. Baron, MD, MSC, at TCT 2017 on Oct. 30 and simultaneously published in the Journal of the American College of Cardiology.
The previously reported main results from EXCEL showed that rates of death, stroke and myocardial infarction (MI) were similar at 36 months with revascularization with the second-generation everolimus-eluting stent XIENCE or CABG in patients with unprotected left main coronary artery disease (LMCAD) and a SYNTAX score ≤32. However, EXCEL also showed that patients who underwent CABG were more likely to experience an MI within the first 30 days and that patients who underwent PCI had a significantly higher rate of revascularization by 36 months.
Of the 1,905 patients randomized in the international, multicenter study, 1,788 participated in the QoL substudy, conducted to understand whether other factors, including patient-reported health status, should be considered when selecting the revascularization strategy for patients with LMCAD.
Assessments were made at baseline and one, 12 and 36 months using five different tools, including the Short Form (SF)-12, Rose Dyspnea Scale, Patient Health Questionnaire-8 and EuroQol (EQ)-5D.
The results showed that an early difference at one month favoring PCI was attenuated by 12 months and at 36 months there was no significant difference between PCI and CABG for QoL. The clinical outcomes at 36 months showed no significant differences in rates of cardiovascular mortality, all-cause mortality, MI or stroke with PCI or CABG. But with PCI there was a higher rate of ischemia-driven revascularization than with CABG (12.6 percent vs. 7.2 percent; p < 0.01).
According to Baron et al., this is the first study to compare the effects of PCI with a contemporary drug-eluting stent (DES) against CABG on patient-reported outcomes in the setting of LMCAD. They note that the FREEDOM and SYNTAX trials, conducted with first-generation DES, showed that CABG resulted in slightly better long-term angina relief than PCI.
The investigators offer several potential explanations for the differences in long-term health status outcomes between PCI and CABG observed in the QoL substudy of EXCEL. These include the fact that while the rate of repeat revascularization was higher with PCI than CABG in EXCEL, this difference was substantially lower than in the FREEDOM and SYNTAX trials. In addition, EXCEL excluded patients with anatomically complex disease and the duration of its QoL substudy was shorter at three years than the five years for FREEDOM and SYNTAX. They also state there was no meaningful difference by subgroups for the effect of revascularization strategy on health status. In contrast to previous studies, EXCEL showed no significant interaction between the extent of angina relief with either strategy and either the SYNTAX score or baseline angina frequency.
Among patients with LMCAD with low or intermediate disease complexity, the authors conclude that, "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 with LMCAD."
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