Extent and distribution of in-stent intimal hyperplasia and edge effect in a non-radiation stent population☆
Section snippets
Study design and patient population
The HIPS trial was a randomized, prospective, multicenter study comparing the safety and efficacy of locally delivered versus intraluminal heparin in patients who underwent IVUS-guided Palmaz-Schatz stenting.6 In all, 179 patients were randomized at 11 centers in North America and Europe; each patient had 1 focal, de novo stenosis in a native coronary artery. The protocol was designed to reflect the current practice of stent implantation in stable patients. Therefore, patients were typical of
Results
Subjects returned for 6-month angiography and IVUS as per protocol rather than based on clinical presentation. At the time of follow-up IVUS, 90% had only class I or class II angina and 95% had negative stress tests. There was no difference in any IVUS parameter between the 2 forms of heparin delivery: local versus systemic heparin.6
Discussion
In this group of asymptomatic or minimally symptomatic nonradiation patients, IH volume 6 months after stenting of focal, de novo coronary lesions ranged from none to 123 mm3, corresponding to 0% to 86% of the stent volume. The mean IH volume was 29% of the stent volume, but there was a very high variability in volume and distribution. In addition, the neointima appeared to extend 2 mm beyond the stent causing edge lumen loss.
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Intimal hyperplasia thickness at follow-up is independent of stent sizea serial intravascular ultrasound study
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The Heparin Infusion Prior to Stenting (HIPS) trialfinal results of a prospective, randomized, controlled trial evaluating the safety of local vascular delivery and effects on late intimal hyperplasia detected by angiography and intravascular ultrasound
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Cited by (50)
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2014, JACC: Cardiovascular InterventionsCitation Excerpt :These 3 patients were treated without previous OCT to examine edge restenosis. In 2 of these patients, a geographic miss (injured or diseased segment not covered by the device, balloon-artery ratio <0.9 or >1.3) was previously reported (15). In total, 12 proximal (24%) and 21 distal (42%) edge dissection flaps were observed post-procedure.
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2013, International Journal of CardiologyCitation Excerpt :Hoffmann et al. reported that BMS edge restenosis was a combination of IH closest to the stent edge and progressively more negative remodeling at distances remote from the stent edge [6]. The mechanism was supported by an analysis from Weissman et al. who also noted that the greatest lumen loss occurred within the first 2 mm from the proximal and distal edges of the stent and was primarily due to IH [12]. However, the mechanism of edge restenosis after DES implantation is not well known.
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2012, Advanced Drug Delivery ReviewsCitation Excerpt :Recent long-term follow-up study (8.3 months) using a 7-hexanoyltaxol (a taxane analog) coated stent, showed minimal amount of neointimal proliferation, however, the peri-stent margins (vessel segments immediately adjacent to the stent ends) showed degrees of lumen narrowing similar to conventional metal stents [103]. Similarly, vascular brachytherapy, where the stented artery is exposed intraluminally to a small dose of β- or γ-radiation (dose = 30 to 55 Gy) for a brief period of time (5 to 20 min), while showing promising short-term results [104], demonstrated a rapid late lumen loss, increased rate of thrombosis requiring patients on prolonged antiplatelet therapy, and edge restenosis (artery adjacent to the stent) that required patients to undergo immediate atherectomy in long-term follow-up studies (1 to 5 yrs) [105–107]. Therefore, it is suggested that brachytherapy does not prevent restenosis, but instead prolongs the process because of a general increase in inflammation and a decrease in re-endothelization of the stented artery [104,108].
Sutureless proximal anastomosis using the PAS-port system: Six-month patency and five-year follow-up in "all-comers"
2010, Annals of Thoracic SurgerySerial Intravascular Ultrasound Analysis of Peri-Stent Remodeling and Proximal and Distal Edge Effects After Sirolimus-Eluting or Paclitaxel-Eluting Stent Implantation in Patients With Diabetes Mellitus
2009, American Journal of CardiologyCitation Excerpt :Using IVUS, edge lumen loss could be divided into plaque growth and negative remodeling. With bare-metal stents, intimal hyperplasia in the proximal or distal stent spread into the contiguous reference segments with progressively more EEM decrease and progressively less plaque or intimal hyperplasia increase at greater distances from the stent edge.13,24,25 In the present study, the Taxus stent was associated with increased edge plaque progression accompanied by lumen reduction without remodeling compared with the Cypher stent, differing most notably in only the first millimeter from the stent edge and therefore less obvious when the proximal and distal 5-mm long edge segments were analyzed as a volume.
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This study was supported by a grant from LocalMed, Inc., Palo Alto, California. Manuscript received and accepted February 19, 2001.