The randomised study of the double dose versus single dose sirolimus-eluting stent for the treatment of diabetic patients with de novo coronary lesions.

Background: Even though sirolimus-eluting stents (SES) have been shown to significantly improve binary restenosis and target lesion revascularisation rates (TLR) compared to bare metal stents in diabetic patients, the revascularisation rate is still higher than those of non-diabetics. Whether a double dose (DD) of sirolimus on a stent would provide a greater reduction in neointimal hyperplasia compared to single dose (SD) SES in de novo coronary lesion of diabetic patients is unknown.

Methods And Results: A total of 56 patients (58 lesions) were prospectively randomised in a double blind fashion in a 1:1 ratio to SD (30 lesions) versus DD (28 lesions). Procedure success was achieved in all patients. QCA results at 6 months were comparable between groups, including the primary endpoint of in-stent late lumen loss (0.19+/-0.29 mm in SD versus 0.18+/-0.33 mm in DD, p=0.96). Furthermore, restenosis was not found inside the stent in either group. By IVUS, there was no late/acquired incomplete stent apposition at follow-up, and% neointimal volume was 2.2+/-1.8% in SD versus 1.7+/-2.0% in DD, p=0.44. At 1-year clinical follow-up, there was no significant difference between groups for major events, including TLR which occurred in 1 patient in SD versus 3 patients in DD, p=0.61. Overall, there was only 1 subacute stent thrombosis (DD arm), and no late thromboses.

Conclusions: Double dose SES did not improve the prevention of neointimal proliferation in diabetic patients with de novo coronary lesion compare to single dose SES.