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CARDia: No evidence PCI was noninferior to CABG in patients with diabetes
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One-year results from the CARDia trial did not indicate that percutaneous coronary intervention with stenting was noninferior to CABG in patients with diabetes and symptomatic multivessel coronary artery disease.
Researchers enrolled 510 patients with diabetes and either multivessel coronary disease or complex single-vessel disease and randomly assigned them to either PCI (n=256) or CABG (n=254). The primary study outcome was a composite of all-cause mortality, MI and stroke, with a secondary outcome that included the addition of repeat revascularization to the primary outcome events. Patients were followed for a median of one year.
The combined rate of death, MI and stroke in the CABG group was 10.5% vs. 13% for the PCI group. The noninferiority margin of 1.3 was exceeded by the upper limit of the CI for the primary study endpoint; these findings could not indicate that PCI was noninferior to CABG, according to the researchers. All-cause mortality in the CABG group was 3.2% vs. 3.2% in the PCI group (P=.97), with repeat revascularization rates of 2% in the CABG group vs. 11.8% in the PCI group (P<.001). The composite of major adverse coronary and cerebral events combining repeat revascularization with the primary endpoint was 11.3% in the CABG group vs. 19.3% in the PCI group (P=.016). The occurrence rate of thrombolysis in MI major bleeding was higher in the CABG group vs. the PCI group (6.1% vs. 1.2%; P=.009).
In a subset of patients undergoing PCI who were assigned to drug-eluting stents (n=350), the rate of death, MI or stroke was 11.6% vs. 12.4% for the patients in the CABG group enrolled at the same time (HR=0.93; 95% CI, 0.51-1.71). For patients undergoing PCI assigned to bare metal stents, the rate was 15.9% vs. 5.7% in the CABG group (HR=2.99; 95% CI, 0.97-9.16).
“The one-year results of the CARDia trial did not demonstrate the noninferiority of PCI vs. CABG for revascularization of diabetic patients,” the researchers concluded. “However, the 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. 2010;55:432-440.