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CLINICAL RESEARCH: INTERVENTIONAL CARDIOLOGY

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

Manuscript received October 31, 2005; revised manuscript received December 29, 2005, accepted January 16, 2006.

^_* Reprint requests and correspondence: Dr. Manel Sabaté, Hospital Clínico San Carlos, Plaza Cristo Rey s/n, 28040 Madrid, Spain. (Email: manelsabate1{at}telefonica.net).

OBJECTIVES: 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.

Abbreviations and Acronyms   BMS = bare-metal stent   DIABETES = Diabetes and Sirolimus-Eluting Stent trial   EEM = external elastic membrane   ISA = incomplete stent apposition   IVUS = intravascular ultrasound   NIH = neointimal hyperplasia   SES = sirolimus-eluting stent

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