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
- 1 December 2005
- journal article
- research article
- Published by Wiley in Catheterization and Cardiovascular Interventions
- Vol. 66 (4) , 499-506
- https://doi.org/10.1002/ccd.20542
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 mm3, 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 mm2, 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 mm2 in the SES group of E‐SIRIUS and 0.5 ± 0.8 mm2 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.Keywords
This publication has 20 references indexed in Scilit:
- Impact of final stent dimensions on long-term results following sirolimus-eluting stent implantationJournal of the American College of Cardiology, 2004
- Long-Term Follow-Up of Incomplete Stent Apposition in Patients Who Received Sirolimus-Eluting Stent for De Novo Coronary LesionsCirculation, 2003
- Sirolimus-Eluting Stents versus Standard Stents in Patients with Stenosis in a Native Coronary ArteryNew England Journal of Medicine, 2003
- Coronary Restenosis After Sirolimus-Eluting Stent ImplantationCirculation, 2003
- A Randomized Comparison of a Sirolimus-Eluting Stent with a Standard Stent for Coronary RevascularizationNew England Journal of Medicine, 2002
- Novel Drug-Delivery StentCirculation, 2001
- Long-term vessel response to a self-expanding coronary stent: a serial volumetric intravascular ultrasound analysis from the ASSURE trialJournal of the American College of Cardiology, 2001
- Analysis of the relation between stent implantation pressure and expansionThe American Journal of Cardiology, 1999
- Vessel Size and Long-Term Outcome After Coronary Stent PlacementCirculation, 1998
- Intravascular Ultrasound Predictors of Angiographic Restenosis in Lesions Treated With Palmaz-Schatz StentsJournal of the American College of Cardiology, 1998