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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

Pilar Jiménez-Quevedo, MD^_*,1, Manel Sabaté, MD, PhD^_*,_*, Dominick J. Angiolillo, MD, Marco A. Costa, MD, PhD, Fernando Alfonso, MD, PhD^_*, Joan Antoni Gómez-Hospital, MD, PhD, Rosana Hernández-Antolín, MD, PhD^_*, Camino Bañuelos, MD^_*, Javier Goicolea, MD, PhD, Francisco Fernández-Avilés, MD, PhD^||, Theodore Bass, MD^_*,,,,||, Javier Escaned, MD, PhD^_*, Raul Moreno, MD^_*, Cristina Fernández, MD, PhD^_*, Carlos Macaya, MD, PhD^_* for the DIABETES Investigators

^_* San Carlos University Hospital, Madrid, Spain
University of Florida Cardiovascular Imaging Core Laboratories, Jacksonville, Florida
"Prínceps d’Espanya" University Hospital, Barcelona, Spain
"Do Meixoeiro" University Hospital, Vigo, Spain
^|| Clínico University Hospital, Valladolid, Spain

View larger version (31K): [in a new window]   Figure 1 (Top panels) Histograms of neointima hyperplasia (NIH) volume in the sirolimus-eluting stent (SES) group (left) and the bare-metal stent (BMS) group (right). A non-Gaussian distribution is demonstrated in both groups (Kolmogorov-Smirnov test: p < 0.0001 for SES group; p = 0.02 for BMS group). The median test evidenced significant differences between groups. (Bottom panels) Histograms of percent volume obstruction in the SES group (left) and the BMS group (right). A non-Gaussian distribution is demonstrated in both groups (Kolmogorov-Smirnov test: p < 0.0001 for SES group; = 0.03 for BMS group). The median test evidenced significant differences between groups.

View larger version (30K): [in a new window]   Figure 2 Patterns of vascular changes at proximal (top panels) and distal edges (bottom panels). In the bare-metal stent group (left), negative remodeling (reduction in external elastic membrane [EEM] volume), led to a reduction in luminal volume despite small reductions in plaque volume. In the sirolimus-eluting stent group (right), vessel enlargement (increase in EEM volume) encompassed an increase in plaque volume, resulting in a net gain in lumen volume. *p = 0.09; p = 0.04; p = 0.05; p = 0.001; ¶p = 0.03 (post-procedure versus 9-month follow-up p values).

View larger version (117K): [in a new window]   Figure 3 (Top) Intravascular imaging of a stent completely apposed immediately after the implantation. (Bottom) Same artery imaging at nine-month follow-up: Late acquired incomplete stent apposition is evidenced.