ABSTRACT
Background: Even though sirolimus-eluting stents (SES) have been shown to significantly improve binaryrestenosis and target lesion revascularisation rates (TLR) compared to bare metal stents in diabeticpatients, 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 blindfashion in a 1:1 ratio to SD (30 lesions) versus DD (28 lesions). Procedure success was achieved in allpatients. QCA results at 6 months were comparable between groups, including the primary endpoint of instentlate lumen loss (0.19±0.29 mm in SD versus 0.18±0.33 mm in DD, p=0.96). Furthermore, restenosiswas not found inside the stent in either group. By IVUS, there was no late/acquired incomplete stentapposition at follow-up, and% neointimal volume was 2.2±1.8% in SD versus 1.7±2.0% in DD, p=0.44. At1-year clinical follow-up, there was no significant difference between groups for major events, includingTLR which occurred in 1 patient in SD versus 3 patients in DD, p=0.61. Overall, there was only 1 subacutestent thrombosis (DD arm), and no late thromboses.Conclusions: Double dose SES did not improve the prevention of neointimal proliferation in diabetic patientswith de novo coronary lesion compare to single dose SES.