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Vascular response to sirolimus‐eluting stents delivered with a nonaggressive implantation technique: Comparison of intravascular ultrasound results from the multicenter, randomized E‐SIRIUS, and SIRIUS trials
Author(s) -
Hoffmann Rainer,
Guagliumi Giulio,
Musumeci Giuseppe,
Reimers Bernhard,
Petronio Anna S,
Disco Clemens,
Amoroso Giovanni,
Moses Jeffrey W.,
Fitzgerald Peter J.,
Schofer Joachim,
Leon Martin B.,
Breithardt Günther
Publication year - 2005
Publication title -
catheterization and cardiovascular interventions
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.988
H-Index - 116
eISSN - 1522-726X
pISSN - 1522-1946
DOI - 10.1002/ccd.20542
Subject(s) - intravascular ultrasound , medicine , sirius , stent , restenosis , intimal hyperplasia , lumen (anatomy) , sirolimus , sirius red , cardiology , radiology , neointimal hyperplasia , fibrosis , stars , physics , astronomy , smooth muscle
Abstract Background: The effectiveness of SES to reduce the risk of restenosis was initially demonstrated in short lesions using stent implantation with routine pre‐dilatation and post‐dilatation. This intravascular ultrasound (IVUS) substudy of the E‐SIRIUS trial sought to evaluate local arterial responses to sirolimus‐eluting stents (SES) delivered with a stent implantation technique allowing direct stenting and only selectively applying high‐pressure post‐dilatation.Methods and Results: IVUS was performed immediately after intervention and at 8‐month follow‐up in 51 patients randomised to either bare‐metal stents (BMS; Bx‐Velocity™; N = 20) or SES (Cypher™ N = 31). Direct stenting was allowed (24%) and post‐dilation was performed only selectively (32%). Lumen dimensions, intimal hyperplasia and vessel remodeling were compared between SES and BMS. Subsequently, results of SES in the E‐SIRIUS IVUS substudy ( N = 31) were compared to those of SES in the IVUS substudy of the SIRIUS trial ( N = 137). SES in SIRIUS IVUS substudy were delivered with 100% pre‐dilatation and 77% post‐dilatation. Baseline stent and reference segment measurements were similar between BMS and SES in E‐SIRIUS IVUS patients. Using SES there was a 96% reduction in intimal hyperplasia volume within the stented segment (1.8 ± 4.9 vs 50.6 ± 39.7 mm 3 , P < 0.001) and a significantly larger minimal lumen cross sectional area at 8‐month follow‐up (4.5 ± 1.1 vs 2.3 ± 0.9 mm 2 , P < 0.001). No vessel remodeling was observed with the use of SES. The applied stent implantation technique resulted in a minimal stent/reference vessel area ratio of 0.75 ± 0.17 in E‐SIRIUS SES as compared to 0.84 ± 0.23 in SIRIUS SES ( P = 0.046). Mean intimal hyperplasia cross‐sectional area at follow‐up was 0.1 ± 0.2 mm 2 in the SES group of E‐SIRIUS and 0.5 ± 0.8 mm 2 in the SES group of SIRIUS ( P = 0.003).Conclusions: An implantation technique of SES which includes direct stenting and minimizes the use of high‐pressure post‐dilatation results in less optimal stent expansion. However, follow‐up results compare very favourable to those of BMS and are characterised by even less intimal hyperplasia than after a more forceful implantation of SES. © 2005 Wiley‐Liss, Inc. © 2005 Wiley‐Liss, Inc.