Bypass Surgery or Stenting for Left Main Coronary Artery Disease in Patients With Diabetes
Milan Milojevic1, Patrick W Serruys2, Joseph F Sabik3
1Erasmus Medical Center, Rotterdam, the Netherlands.
Insights
In patients with left main coronary artery disease (LMCAD), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) showed similar 3-year outcomes, even for those with diabetes. This study confirms PCI is a viable option for diabetic LMCAD patients.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- The EXCEL trial compared percutaneous coronary intervention (PCI) with coronary artery bypass grafting (CABG) for left main coronary artery disease (LMCAD).
- Previous trials suggested CABG may be superior for diabetic patients with LMCAD, but EXCEL's diabetic subgroup was not fully analyzed.
- This analysis investigates if PCI outcomes differ from CABG in diabetic versus non-diabetic LMCAD patients.
Purpose of the Study:
- To evaluate the impact of diabetes on the 3-year outcomes of LMCAD patients treated with PCI versus CABG.
- To determine if PCI with everolimus-eluting stents is non-inferior to CABG in diabetic patients with LMCAD.
Main Methods:
- A pre-specified subgroup analysis of the randomized EXCEL trial.
- 1,905 patients with LMCAD and low/intermediate SYNTAX scores (≤32) were randomized to PCI or CABG.
- Patients were stratified by diabetes status, and outcomes were compared at 3 years.
Main Results:
- Diabetic patients had a significantly higher 3-year composite primary endpoint rate (death, stroke, MI) than non-diabetic patients (20.0% vs. 12.9%).
- PCI and CABG demonstrated similar 3-year primary endpoint rates in both diabetic (20.7% vs. 19.3%) and non-diabetic (12.9% vs. 12.9%) patients.
- All-cause death at 3 years was higher with PCI (13.6%) versus CABG (9.0%), but no significant interaction between diabetes and treatment was observed for death or other endpoints.
Conclusions:
- The 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent between diabetic and non-diabetic patients with LMCAD and low/intermediate SYNTAX scores.
- PCI is a safe and effective revascularization strategy for diabetic patients with LMCAD.
- The EXCEL trial provides crucial data on the long-term efficacy of PCI versus CABG in diabetic populations.
Background:
The randomized EXCEL (Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization) trial reported a similar rate of the 3-year composite primary endpoint of death, myocardial infarction (MI), or stroke in patients with left main coronary artery disease (LMCAD) and site-assessed low or intermediate SYNTAX scores treated with percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG). Whether these results are consistent in high-risk patients with diabetes, who have fared relatively better with CABG in most prior trials, is unknown.
Objectives:
In this pre-specified subgroup analysis from the EXCEL trial, the authors sought to examine the effect of diabetes in patients with LMCAD treated with PCI versus CABG.
Methods:
Patients (N = 1,905) with LMCAD and site-assessed low or intermediate CAD complexity (SYNTAX scores ≤32) were randomized 1:1 to PCI with everolimus-eluting stents versus CABG, stratified by the presence of diabetes. The primary endpoint was the rate of a composite of all-cause death, stroke, or MI at 3 years. Outcomes were examined in patients with (n = 554) and without (n = 1,350) diabetes.
Results:
The 3-year composite primary endpoint was significantly higher in diabetic compared with nondiabetic patients (20.0% vs. 12.9%; p < 0.001). The rate of the 3-year primary endpoint was similar after treatment with PCI and CABG in diabetic patients (20.7% vs. 19.3%, respectively; hazard ratio: 1.03; 95% confidence interval: 0.71 to 1.50; p = 0.87) and nondiabetic patients (12.9% vs. 12.9%, respectively; hazard ratio: 0.98; 95% confidence interval: 0.73 to 1.32; p = 0.89). All-cause death at 3 years occurred in 13.6% of PCI and 9.0% of CABG patients (p = 0.046), although no significant interaction was present between diabetes status and treatment for all-cause death (p = 0.22) or other endpoints, including the 3-year primary endpoint (p = 0.82) or the major secondary endpoints of death, MI, or stroke at 30 days (p = 0.61) or death, MI, stroke, or ischemia-driven revascularization at 3 years (p = 0.65).
Conclusions:
In the EXCEL trial, the relative 30-day and 3-year outcomes of PCI with everolimus-eluting stents versus CABG were consistent in diabetic and nondiabetic patients with LMCAD and site-assessed low or intermediate SYNTAX scores.(Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization [EXCEL]; NCT01205776).
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