Manel Sabaté, MD, PhD, Hospital Clinico San Carlos, Madrid, Spain, presented that the use of a sirolimus-eluting stent in diabetic patients more effectively reduced in-segment late lumen loss and restenosis than a bare metal stent, according to results of the DIABETES trial. DIABETES assessed the efficacy of sirolimus-eluting stents following successful coronary stent implantation in 160 diabetic patients with de novo coronary stenoses, half of whom received bare-metal stents.
There was an 82% (P<.0001) re duc tion in late lumen loss in the sirolimus-eluting stent group compared to the bare-metal stent group, from 0.44 mm to 0.08 mm. The restenosis rate was reduced 76%, from 33% in the bare metal stent group to 7.7% in the sirolimus-eluting stent group.
There were no differences in cardiac death, Q-wave MI or non-Q-wave MI. There was a significant difference in target lesion revascularization (TLR) (7.5% vs. 31.3%; P<.0001) and major adverse coronary events (11.3% vs. 36.3%; P<.0001). Almost 90% of patients in the sirolimus-eluting stent group were free from major adverse coronary events at nine months.
There were no differences in baseline characteristics. Mean age of patients was 66 years and 62.5% of patients were men. One-third of patients were insulin dependent and two-thirds were not. Reference diameter was 2.34 mm on average. Excluding chronic total occlusions, lesion length was on average 15 mm. There was no difference in procedural characteristics between the groups.
Inclusion criteria were diabetic patients (non-insulin dependent or insulin dependent) with coronary lesions in native arteries and symptoms or objective evidence of ischemia.
Patients were excluded if they were diabetic without pharmacological treatment, or if they had stenoses located in true bifurcations, SVG, LIMA or unprotected left main vessel, in-stent restenosis, chronic renal or hepatic insufficiency, previous brachytherapy or DES implantation; recent AMI with CPK above normal levels; or malignancy. Abciximab was recommended for all patients.