Vascular effects of sirolimus-eluting versus bare-metal stents in diabetic patients: three-dimensional ultrasound results of the Diabetes and Sirolimus-Eluting Stent (DIABETES) Trial.
OBJECTIVE
A predefined intravascular ultrasound (IVUS) substudy was performed to evaluate the vascular effects of sirolimus-eluting stent (SES) versus bare-metal stent (BMS).


BACKGROUND
The Diabetes and Sirolimus-Eluting Stent (DIABETES) trial is a prospective, multicenter, randomized, controlled trial aimed at demonstrating the efficacy of the SES compared with BMS in diabetic patients.


METHODS
Serial intravascular ultrasound analyses were performed in 140 lesions (SES = 75; BMS = 65) immediately after stent implantation and at nine-month follow-up. Vessel, luminal, and stent mean areas and volumes were evaluated at both edges and within the stented segment. Qualitative assessment of residual dissections and stent apposition were also performed.


RESULTS
Baseline clinical and angiographic characteristics were similar between groups. At 9 months, in-stent neointimal hyperplasia (NIH) mean area and volume were significantly reduced in the SES group (median NIH area 0.01 mm2 [0.0 to 0.1] vs. 2.0 mm2 [1.0 to 2.9] and median NIH volume 0.11 mm3 [0 to 2.1] vs. 35.3 mm3 [16.6 to 62.6]; both p < 0.0001). In the SES group, stent edges evidenced significant increase in lumen dimensions mainly due to significant increase in vessel volume, whereas those of the BMS group presented vessel shrinkage leading to significant lumen reduction. Late acquired incomplete stent apposition was observed in 11 lesions (14.7%) in the SES group and 0 in the BMS group (p = 0.001). At one year, no stent thromboses occurred in malapposed stents.


CONCLUSIONS
The SES implantation effectively inhibits NIH in diabetic patients. The antirestenotic effect of SES is also appreciated at the stent edges. Late acquired stent malapposition is a frequent phenomenon in diabetic patients treated with SES.
Jiménez-Quevedo
Pilar
P
San Carlos University Hospital, Madrid, Spain.
Sabaté
Manel
M
Angiolillo
Dominick J
DJ
Costa
Marco A
MA
Alfonso
Fernando
F
Gómez-Hospital
Joan Antoni
JA
Hernández-Antolín
Rosana
R
Bañuelos
Camino
C
Goicolea
Javier
J
Fernández-Avilés
Francisco
F
Bass
Theodore
T
Escaned
Javier
J
Moreno
Raul
R
Fernández
Cristina
C
Macaya
Carlos
C
D000368:Aged; D017023:Coronary Angiography; D003327:Coronary Disease / Q000000981:diagnostic imaging / Q000628:therapy*; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000628:therapy*; D004867:Equipment Design; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D006965:Hyperplasia / Q000517:prevention & control; D021621:Imaging, Three-Dimensional; D008297:Male; D008670:Metals; D008875:Middle Aged; D020123:Sirolimus / Q000008:administration & dosage* / Q000627:therapeutic use; D015607:Stents; D016896:Treatment Outcome; D017539:Tunica Intima / Q000000981:diagnostic imaging; D018084:Ultrasonography, Interventional
D008670:Metals; D020123:Sirolimus