An underpowered, randomized controlled trial has concluded that drug-eluting stents are associated with higher mortality and fewer nonfatal MIs than CABG in patients with diabetes.
The primary outcome measure was a composite of nonfatal MI or death, but slow enrollment meant the study was severely underpowered to draw a conclusion. The study was terminated early at 2 years compared with the planned 3.7 years and, as a result, enrolled only 25% of the intended sample size.
At 2 years, researchers observed differences regarding all-cause mortality (CABG, 5% vs. PCI, 21%; HR=0.3; 95% CI, 0.11-0.8) and risk for nonfatal MI (CABG, 15% vs. PCI, 6.2%; HR=3.32; 95% CI, 1.07-10.3). These components of the composite endpoint offset one another, giving a combined risk for death or nonfatal MI of 18.4% for CABG vs. 25.3% for PCI (HR=0.89; 95% CI, 0.47-1.71).
There were no differences on the basis of HbA1c or insulin use, with the exception of all-cause mortality (CABG, 3.5% vs. PCI, 28.3%; P=.05) in the largest subgroup (HbA1c <8%).
Stephen G. Ellis, MD, of the Cleveland Clinic and author of an accompanying editorial, wrote that CABG is preferable to PCI in patients with diabetes and multivessel disease with complex anatomy (SYNTAX scores >22) and perhaps even in all patients with diabetes and multivessel disease.
“That said, we still need further data regarding the important interaction between lesion number and complexity and clinical outcomes with the two approaches,” he said. “Furthermore, patients will continue to have unique risk patterns and values. The best recommendations will contextualize an individual’s needs relative to the body of data generally favoring surgery.”
Disclosure: Ellis and Kamalesh report no relevant financial disclosures.
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