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EXCEL: PCI may be acceptable in patients with diabetes, less complex left main CAD

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WASHINGTON, D.C. — Three-year data from the EXCEL trial indicate that PCI with an everolimus-eluting stent may be acceptable or even preferable to CABG for treatment of patients with diabetes, left main coronary artery disease and a low to intermediate SYNTAX score, according to data presented at the American College of Cardiology Scientific Sessions.

Optimal revascularization strategy in patients with diabetes who have left main CAD remains unclear, A. Pieter Kappetein, MD, PhD, of Erasmus Medical Centre, Rotterdam, Netherlands, noted during a presentation. However, a subset analysis from the SYNTAX trial suggested that drug-eluting stents may be beneficial in patients with left main disease with low or moderate CAD complexity.

In the EXCEL trial, Kappetein and colleagues randomly assigned 1,905 patients with left main CAD and a SYNTAX score of 32 or lower to PCI with EES or CABG. In this subgroup analysis of patients with diabetes, the primary endpoint was a composite of death, stroke or MI at 3 years. Secondary endpoints included the primary endpoint at 30 days and the composite rate of death, stroke, MI or ischemia-driven revascularization at 3 years.

A. Pieter Kappetein

Of 548 patients with diabetes and unprotected left main disease, 286 were randomly assigned PCI with EES (Xience, Abbott Vascular) and 268 to CABG. Of all patients with diabetes, 49 were treated with diet only, 358 were treated with oral agents and 147 were treated with insulin.

At 3 years, the risk for death, stroke or MI was higher among patients with diabetes compared with those without diabetes (19.9% vs. 13%; HR = 1.6; 95% CI, 1.25-2.04). The primary endpoint occurred at similar rates in the PCI and CABG groups (20.3% and 19.6%, respectively; HR = 0.99; 95% CI, 0.68-1.45). Kappetein noted, however, that data from 5-year follow-up are needed before researchers can draw firm conclusions.

Outcomes, including death, stroke, MI and unplanned revascularization were worse in patients with diabetes who were treated with insulin, as compared with those not treated with insulin or patients without diabetes (26.6% vs. 25.9% vs. 19%; P < .01).

Thirty-day outcomes favored PCI over CABG in terms of the primary endpoint (5.3% vs. 9.8%; HR = 0.53; 95% CI, 0.28-1), Kappetein noted.

“What we can conclude from this subset from the EXCEL study is that treatment of patients with left main CAD and diabetes with low or intermediate SYNTAX scores had similar primary endpoints of death, stroke or MI at 3 years with fewer adverse events within 30 days,” he said, noting that longer-term follow-up is still necessary and that the decision to perform PCI in this patient population should be made by the entire heart team. – by Melissa Foster

Reference:

Kappetein AP. Abstract 1135M-03. Presented at: American College of Cardiology Scientific Session; March 17-19, 2017; Washington, D.C.

Disclosure: EXCEL was sponsored by Abbott Vascular. Kappetein reports no relevant financial disclosures.