Study of EXCEL Data Finds That Sex Is Not an Independent Predictor of Adverse Revascularization Outcomes
July 10, 2018—Patrick W. Serruys, MD, et al published findings from a study to assess outcomes after percutaneous coronary intervention (PCI) and coronary artery bypass grafting surgery (CABG) according to sex in the large randomized EXCEL trial of patients with unprotected left main disease. The study was published online in the Journal of the American College of Cardiology (JACC): Cardiovascular Interventions.
The investigators explained that the SYNTAX trial demonstrated that patient sex had a significant interaction effect with revascularization strategy, and that women had an overall higher mortality when treated with PCI than CABG.
The multinational, randomized EXCEL trial evaluated the effectiveness of PCI with the Xience everolimus-eluting stent (Abbott Vascular) versus CABG for left main revascularization in patients with unprotected left main disease. The primary endpoint was the composite of all-cause death, myocardial infarction (MI), or stroke at 3 years.
As summarized by the investigators, the study randomized 1,905 patients (1,464 [76.9%] men and 441 [23.1%] women). Compared with men, women were older; had higher prevalence rates of hypertension, hyperlipidemia, and diabetes; and were less commonly smokers but had lower coronary anatomic burden and complexity (mean SYNTAX score, 24.2 vs 27.2; P < .001). By multivariate analysis, sex was not independently associated with either the primary endpoint (hazard ratio [HR], 1.10; 95% confidence interval [CI], 0.82–1.48; P = .53) or all-cause death (HR, 1.39; 95% CI, 0.92–2.10; P = .12) at 3 years.
At 30 days, all-cause death, MI, or stroke had occurred in 8.9% of women treated with PCI, 6.2% of women treated with CABG, 3.6% of men treated with PCI, and 8.4% of men treated with CABG (P interaction = .003). The 3-year rate of the composite primary endpoint was 19.7% in women treated with PCI, 14.6% in women treated with CABG, 13.8% in men treated with PCI, and 14.7% in men treated with CABG (P interaction = .06). These differences were driven by higher periprocedural rates of MI in women after PCI and in men after CABG.
The investigators concluded that in patients with unprotected left main disease in the EXCEL trial, sex was not an independent predictor of adverse outcomes after revascularization. However, women undergoing PCI had a trend toward worse outcomes, a finding related to associated comorbidities and increased periprocedural complications. Further studies are required to determine the optimal revascularization modality in women with complex coronary artery disease, advised the investigators in JACC: Cardiovascular Interventions.