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CARDia: PCI not noninferior to CABG for patients with diabetes

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One-year data do not demonstrate that percutaneous coronary intervention is noninferior to coronary artery bypass graft surgery in patients with diabetes and coronary heart disease, according to findings from the Coronary Artery Revascularization in Diabetes (CARDia) trial.

CARDia included 510 patients with diabetes and multivessel or complex single-vessel coronary disease who were randomly assigned to PCI plus stenting and routine abciximab (n=248) or CABG (n=242).

At one year, the combined rate for death, MI and stroke was 10.5% in the CABG group vs. 13% in the PCI group (HR=1.25; 95% CI, 0.75-2.09).

“The non-inferiority margin of 1.3 was exceeded by the upper limit of the confidence interval for the primary endpoint, indicating that our results could not demonstrate that PCI is inferior to CABG,” the researchers wrote in the Journal of the American College of Cardiology.

All-cause mortality was 3.2% in both the CABG and PCI groups (HR=0.98, 95% CI, 0.37 to 2.61). The rates of death, MI, stroke or repeat revascularization were 11.3% in the CABG group and 19.3% in the PCI group (HR=1.77; 95% CI, 1.11-2.82).

Patients assigned to PCI were originally assigned to bare-metal stents but switched to sirolimus-eluting stents (Cordis, Johnson & Johnson) when they became available. In the subset of patients assigned to drug-eluting stents (69%), the composite rate of death, MI and stroke was 12.4% compared with 11.6% in those assigned to CABG (HR=0.93; 95% CI, 0.51-1.71).

Recent advances in PCI have led to uncertainties over whether CABG remains the preferred method of revascularization in patients with diabetes.

“The CARDia trial did show that multivessel PCI is feasible in patients with diabetes,” the researchers concluded. “These results suggest that there could be greater equipoise between the two strategies, with the decision to use CABG or PCI being based on information from clinical trials, clinician judgment and patient preference.”

Kapur A. J Am Coll Cardiol. 2009;doi:10.1016/j.jacc.2009.10.014.