Everolimus-eluting stents noninferior to CABG for left main coronary disease: The EXCEL trial

1. Rate of death, stroke, and MI at three years were equivalent in patients with left main coronary disease treated with either everolimus-eluting stent or coronary-artery bypass grafting (CABG).

2. Ischemia-driven revascularization at three years was equivalent in the two groups.

Evidence Rating Level: 1 (Excellent)

Study Rundown: Randomized trials have suggested that for selected patients with left main coronary disease drug-eluting stents may be an acceptable alternative to CABG. One important parameter in the selection of such patients is arterial anatomic complexity. In the Evaluation of XIENCE versus Coronary Artery Bypass Surgery for Effectiveness of Left Main Revascularization (EXCEL) trial, patients with left main coronary artery disease of low to intermittent anatomical complexity were randomized to undergo percutaneous coronary intervention (PCI) with everolimus-eluting stents (PCI group) or CABG.

The primary end point was the rate of a composite of all-cause mortality, stroke, or MI at 3 years. Major secondary end points included the rate of a composite of all-cause mortality, stroke, or MI at 30 days and at 3 years. At 3 years, the primary end point demonstrated significant noninferiority in the PCI group. The 30-day secondary endpoint demonstrated significant noninferiority and superiority in the PCI group. The 3-year secondary endpoint demonstrated significant noninferiority in the PCI group.

This study draws strength from well-delineated patient selection and selection of discrete treatment arms, but the generalizability of its findings could be considered limited by their 3-year follow-up term.

Click to read the study, published in NEJM

Relevant Reading: Design and rationale for a randomized comparison of everolimus-eluting stents and coronary artery bypass graft surgery in selected patients with left main coronary artery disease: the EXCEL trial.

In-Depth [randomized controlled trial]: This large-scale trial involved patients with left main coronary artery disease of low to intermittent arterial anatomic complexity. A total of 1905 patients were randomized in a 1:1 ratio to undergo PCI with everolimus-eluting stents (n = 948) or CABG (n = 957). At 3 years, a primary end-point event had occurred in 15.4% of the patients in the PCI group and in 14.7% of the patients in the CABG group (HR 1.00; 95%CI 0.79 to 1.26; p = 0.98 for superiority; p = 0.02 for noninferiority). The secondary end-point event of death, stroke, or MI at 30 days occurred in 4.9% of the patients in the PCI group and in 7.9% in the CABG group (p < 0.001 for noninferiority, p = 0.008 for superiority). The secondary end-point event of death, stroke, MI, or ischemia-driven revascularization at 3 years occurred in 23.1% of the patients in the PCI group and in 19.1% in the CABG group (p = 0.01 for noninferiority, p = 0.10 for superiority).

Image: PD

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