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.
BACKGROUND
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Hur
Seung-Ho
SH
Center for Cardiovascular Technologies, Stanford University Medical Center, Stanford, CA 94305-563, USA.
Ako
Junya
J
Shimada
Yoshihisa
Y
Tsujino
Ichizo
I
Hassan
Ali H M
AH
Abizaid
Alexandre
A
Shiran
Avinoam
A
Lewis
Basil S
BS
Guagliumi
Giulio
G
Cohen
Sidney A
SA
Honda
Yasuhiro
Y
Fitzgerald
Peter J
PJ
Sousa
J Eduardo
JE
D019917:Blood Vessel Prosthesis Implantation; D023903:Coronary Restenosis / Q000000981:diagnostic imaging* / Q000188:drug therapy*; D003925:Diabetic Angiopathies / Q000150:complications*; D004305:Dose-Response Relationship, Drug; D054855:Drug-Eluting Stents; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D006965:Hyperplasia; D007166:Immunosuppressive Agents / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D020123:Sirolimus / Q000008:administration & dosage; D017539:Tunica Intima / Q000000981:diagnostic imaging* / Q000187:drug effects / Q000473:pathology; D018084:Ultrasonography, Interventional
D007166:Immunosuppressive Agents; D020123:Sirolimus