Two-year intravascular ultrasound observations in diabetic patients treated with single and double dose sirolimus-eluting stents: results of the double dose diabetes (3D) study

• Published in: The Journal of invasive cardiology 2008-08, Vol.20 (8), p.411-416
• Main Authors: Hur, Seung-Ho, Ako, Junya, Shimada, Yoshihisa, Tsujino, Ichizo, Hassan, Ali H M, Abizaid, Alexandre, Shiran, Avinoam, Lewis, Basil S, Guagliumi, Giulio, Cohen, Sidney A, Honda, Yasuhiro, Fitzgerald, Peter J, Sousa, J Eduardo
• Format: Article
• Language: English
• Subjects: Blood Vessel Prosthesis Implantation; Coronary Restenosis - diagnostic imaging; Coronary Restenosis - drug therapy; Diabetic Angiopathies - complications; Dose-Response Relationship, Drug; Drug-Eluting Stents; Feasibility Studies; Female; Humans; Hyperplasia; Immunosuppressive Agents - administration & dosage; Male; Middle Aged; Prospective Studies; Sirolimus - administration & dosage; Tunica Intima - diagnostic imaging; Tunica Intima - drug effects; Tunica Intima - pathology; Ultrasonography, Interventional
• ISSN: 1557-2501

Diabetes has been reported as an independent predictor of restenosis after drug-eluting stent implantation. The purpose of this study was to assess the long-term impact of increased drug dose in sirolimus-eluting stents (SES) on neointimal hyperplasia (NIH) in diabetic patients using volumetric intravascular ultrasound analysis. The 3D trial is a multicenter, prospective, randomized, feasibility study of double-dose (280 microg/cm2) or conventional single-dose (140 microg/cm2) SES for the treatment of de novo coronary lesions in diabetic patients. To evaluate long-term efficacy, complete serial volumetric analyses (baseline, 6-month and 2-year follow up) were performed in 39 diabetic patients (17 single-dose, 22 double-dose). Each volume was divided by stent length to acquire volume index, expressed as mm3/mm. Percent neointimal volume was calculated as (neointimal volume/stent volume) x 100 at follow up. Volumetric analysis showed similar results over time between the 2 stent groups (p = NS for all). At 2-year follow up, minimal increases in NIH area and percent NIH were observed in both groups, which translated into a decrease in lumen volume index compared to baseline (p < 0.05 for all). No late-acquired incomplete stent apposition was observed in either group. The current single dose of sirolimus in SES is effective in inhibiting NIH in diabetic patients up to 2 years. In this patient subset, double-dose SES did not confer additional NIH suppression at 2-year follow up compared to conventional single-dose SES.