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Edge Effect From Drug-Eluting Stents as Assessed With Serial Intravascular Ultrasound

2012; Lippincott Williams & Wilkins; Volume: 5; Issue: 2 Linguagem: Inglês

10.1161/circinterventions.111.966259

1941-7632

Kohei Wakabayashi, Ron Waksman, Neil J. Weissman,

Cerebrovascular and Carotid Artery Diseases

HomeCirculation: Cardiovascular InterventionsVol. 5, No. 2Edge Effect From Drug-Eluting Stents as Assessed With Serial Intravascular Ultrasound Free AccessReview ArticlePDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessReview ArticlePDF/EPUBEdge Effect From Drug-Eluting Stents as Assessed With Serial Intravascular UltrasoundA Systematic Review Kohei Wakabayashi, MD, PhD, Ron Waksman, MD and Neil J. Weissman, MD Kohei WakabayashiKohei Wakabayashi From the MedStar Health Research Institute at Washington Hospital Center, Washington, DC. , Ron WaksmanRon Waksman From the MedStar Health Research Institute at Washington Hospital Center, Washington, DC. and Neil J. WeissmanNeil J. Weissman From the MedStar Health Research Institute at Washington Hospital Center, Washington, DC. Originally published1 Apr 2012https://doi.org/10.1161/CIRCINTERVENTIONS.111.966259Circulation: Cardiovascular Interventions. 2012;5:305–311IntroductionSeveral studies have demonstrated effective reduction of intimal hyperplasia within a drug-eluting stent (DES) when compared with a bare metal stent (BMS), thereby resulting in a lower incidence of target lesion revascularization.1–3 Restenosis at the stent edges, however, is not appreciably reduced by DES. Thus, to understand stent edge effect in DES, it is important to improve the efficacy of this technology. The concern that stent edge effects alter intimal hyperplasia in the stent but not at the edges has existed for many years, and often is described as the "candy wrapper phenomenon." This phenomenon was first described in radioactive stents4,5 and is due to local inhibition of intimal growth and endothelial healing6 only within the stent. Many DES trials, therefore, sought to better understand the edge effect using intravascular ultrasound (IVUS) to assess the vessel response post stent implantation.Many studies have documented DES edge effect in older- and newer-generation DES. One challenge facing IVUS studies that assess DES edge effect is a high degree of patient-to-patient variability, along with potential variability among the different DES types. Because of these variables and the relatively small size of most sequential IVUS studies, there is no general consensus regarding stent edge effect in DES. We therefore reviewed the literature to find common findings and tendency. This review focused on 4 DES types approved by the United States Food and Drug Administration: the Cypher sirolimus-eluting stent (SES) (Cordis), the Taxus paclitaxel-eluting stent (PES) (Boston Scientific), the Endeavor zotarolimus-eluting stent (ZES) (Medtronic CardioVascular Inc.), and the XIENCE V everolimus-eluting stent (EES) (Abbott Vascular).Mechanical Edge Effect Post Stent ImplantationEdge stenosis can occur from several different mechanisms: a vascular response from peri-stent vascular injury, plaque shift, and thrombus or hematoma formation post stent implantation. Before discussing DES and the impact of adding a drug to a stent platform, it is helpful to fully understand the edge effect from BMS implantation.In a comprehensive study of BMS,7 the major changes at the edge were plaque and media (P&M) increase and lumen area decrease observed within the first 1 to 2 mm from the stent edge. The degree of P&M increase within the first 2 mm of the stent edge was correlated with the degree of intimal hyperplasia within the stent. This relationship did not hold true beyond 2 mm of the stent edge. The impact of a BMS on the edge segment progressively decreases at greater distances from the stent edge.7–9 These findings are consistent with the results of the BMS arm (as a control group) in several DES studies. Thus, it is generally recognized that lumen loss in close proximity to the stent was mostly caused by P&M increase (or intimal hyperplasia spread beyond the stent edges) in BMS.Edge Effect of DESPrevious reports written in English were searched comprehensively in PubMed on November 1, 2010. The following terms were used to search: intravascular ultrasound, stent, and coronary. Additionally, the following terms were searched separately: sirolimus, paclitaxel, zotarolimus, and everolimus. A total of 275 articles were identified at first search. Sixty-one articles were excluded because of their nature: review, case report, letter communication, or animal study. Nineteen studies that treated restenosis or saphenous vein graft lesions were excluded. Twenty-eight studies with different platforms, such as self-expandable stents, bioabsorbable stents, biodegradable polymers, different drugs, or oral rapamycin were excluded.In DES, drug and polymer effects have the potential to further influence the mechanical edge effect from the BMS, and the physical effects from the stent implantation. Most studies define stent "edge" as the peri-stent segments within 5 mm of the stent edge. From the BMS literature we know that edge effects vary depending on the distance from the edge (changes that occur within the first 1 to 2 mm from the stent edge are not synonymous with changes that occur 4 to 5 mm from the stent edge).9 This review will discuss edge effect using specific millimeter by millimeter assessments from the stent edge if available.Paclitaxel-Eluting StentsThe TAXUS II trial10 studied the vessel response of the slow- and moderate-release formulation of PES compared with BMS. In this trial, there was an increase in vessel area and P&M area for the segments closest to the edge of the PES 6 months after implantation. The luminal area at the distal edge of PES was significantly greater than that of BMS at follow up owing to the occurrence of positive vessel remodeling in volume analysis. Within the PES cohorts, there was greater decrease in lumen area at the proximal compared with the distal edges both in moderate- (P=0.01) and slow-release groups (P=0.03).The TAXUS IV, TAXUS V, and TAXUS VI trials11,12 were prospective, multicenter, randomized studies that compared the outcomes of PES versus BMS implantation in patients who underwent percutaneous coronary intervention. A prospective IVUS subgroup was prespecified in each trial. The TAXUS IV trial11 confirmed and expanded the results from TAXUS II, showing no aggravation of edge stenosis. Nonetheless, there were some differences between the 2 studies. In TAXUS IV there was a decrease in vessel area and lumen area at the distal edge of the PES, with a slight increase in P&M area. The luminal area at the distal edge nearest the PES was greater than that of the BMS at follow up, owing to the occurrence of less negative vascular remodeling in PES as compared with BMS. The integrated analysis of the IVUS subgroups from TAXUS IV, V, and VI trials12 provides detailed information of the stent edge effect with a relatively large sample size (PES: n=287; BMS: n=260). Less lumen reduction due to less negative remodeling was observed at the distal edge of PES compared with that of BMS, despite an almost similar amount of P&M. A comparable change was observed at the proximal edges of both the PES and BMS. The beneficial effect of the PES was most notable in the area closest to its distal edge.ASPECT (ASian Paclitaxel-Eluting Stent Clinical Trial)13 assessed the effectiveness of a polymer-free PES (high dose and low dose) compared with BMS. Lumen reduction appeared less in the segments immediately adjacent to the edge of the high-dose PES compared with the BMS or the low-dose PES, although formal statistical analysis was not reported.The DiabeDES (Diabetes and Drug-Eluting Stent) trial14 assessed intimal hyperplasia after SES and PES implantation in diabetic patients. Lumen volume decreased at the proximal edge of the PES (P=0.028) because of plaque progression (P=0.006) during 8 months of follow up. At the PES distal edge there was an insignificant lumen volume decrease (P=0.092). A millimeter by millimeter analysis was performed along the length of the edge, which showed that the lumen reduction was due to plaque progression, most notably at the first millimeter immediately proximal and distal to the stent edge.Vascular responses to PES in ST-segment elevation myocardial infarction were addressed in the IVUS substudy of the prospective, multicenter Harmonizing Outcomes With Revascularization and Stents in Acute Myocardial Infarction (HORIZONS-AMI) trial, randomization 3:1 to PES or BMS.15 At the proximal edge, lumen reduction (mean change in lumen cross sectional area: −0.7 in PES, −0.6 in BMS mm2) due to negative remodeling was observed in both PES and BMS (mean change in external elastic membrane cross sectional area: −0.5, −0.8 mm2). However, at the distal edge, less lumen reduction (−0.2 mm2) with no remodeling (0 mm2) was observed in PES, while lumen reduction (−0.4 mm2) with negative remodeling (−0.8 mm2) was observed in BMS.Using IVUS, the BETAX (BEside TAXus) Study16 aimed to specifically assess the temporal changes occurring at the edges of PES. Lumen area with positive remodeling was observed at both proximal and distal edges (Table 1). The pattern of vessel response in millimeter by millimeter analysis along the length of the stent edge was different from the other studies in many respects. These differences may be due to selection bias, a relatively small sample size, stent platform, or procedural differences, as suggested by Fitzgerald et al.17Table 1. Edge Effect of Paclitaxel-Eluting StentsStudy NameFirst AuthorPatients, nFollow Up, mProximal Edge Up to 5 mmDistal Edge Up to 5 mmAnalysisEEM, mmP&M, mmLumen, mmEEM, mmP&M, mmLumen, mmTAXUS II*SerruysModerate-release 1076↑ ↓ 1–2, 3–5↑ 1–5↓ 1–5↑ 1–5↑ ↓ 1–4, 5↓ ↑ 1–4, 5mm by mmSlow-release 106↑ ↓ 1–2, 3–5↑ 1–5↓ 1–5↑ 1–5↑ 1–5↓ ↑ 1, 2–5TAXUS IV†Weissman889↓ ↑ 1–4, 5↑ 1–5↓ 1–5↓ 1–5↑ 1–5↓ 1–5mm by mmTAXUS IV, V, VI‡Weissman2879↓ 1–5↑ 1–5↓ 1–5↑ ↓ 1, 2–5↑ 1–5↓ 1–5mm by mmASPECT§HongLow dose 286↓ 1–5↑ ↓ 1–2, 3–5↓ 1–5↑ ↓ 1, 2–5↑ 1–5↓ 1–5mm by mmHigh dose 28↑ ↓ 1–3, 4–5↑ ↓ 1–3, 4–5↑ 1–5↑ ↓ 1, 2–5↑ ↓ 1–3, 4–5↓ 1–5DiabeDES∥Jensen348↑ ↓ 1–2, 3–5↑ 1–5↓ 1–5↑ ↓ 1–3, 4–5↑ 1–5↓ 1–5mm by mmHORIZON –AMI**Maehara16313↓↑↓→↑↓VolumeBETAX††García-García246↑ 1–5↑ ↓ 1–4, 5↓ ↑ 1, 2–5↑ 1–5↑ ↓ 1–2, 3–5↑ 1–5mm by mmEndeavor IV‡‡Waseda988↓↑↓→↑↓VolumeArrows indicate an increase or decrease from baseline to follow-up.EEM indicates external elastic membrane; P&M, plaque and media.*Data from Serruys PW, et al.10†Data from Weissman NJ, et al.11‡Data from Weissman NJ, et al.12§Data from Hong MK, et al.13∥Data from Jensen LO, et al.14**Data from Maehara A, et al.15††Data from García-García HM, et al.16‡‡Data from Waseda K, et al.26In summary, the consecutive serial IVUS studies from the TAXUS trials demonstrated no negative edge effects due to the paclitaxel in a PES compared with BMS. Release speed of paclitaxel does not appear to be related to the edge effect, but higher-dose paclitaxel seems to have an advantageous effect on the distal lumen. The beneficial effect of less lumen reduction with less negative vessel remodeling was observed at the PES distal edge when compared with BMS. However, it should be noted that despite the benefits of paclitaxel over a BMS for preservation of the distal lumen, the majority of studies indicated that lumen area at both the PES proximal and distal edges still demonstrated some decrease during the follow up period.Sirolimus-Eluting StentsThe first-in-man registry18 of SES performed a serial volumetric IVUS analysis of the stent edges and compared the efficacy of SES for de novo coronary artery lesions (n=43) versus in-stent restenosis (n=37). In de novo lesions, lumen reduction due to both negative remodeling and P&M increase was found at the proximal stent edge, while lumen enlargement due to positive remodeling was found at the distal stent edge.In the IVUS substudy of E-SIRIUS (European, multicenter, randomized, double blind trial of the sirolimus-coated Bx-Velocity stent in the treatment of patients with de novo coronary artery lesions),19 lumen reduction was observed at the proximal edge both in SES and BMS, while significantly less lumen reduction was observed at the distal edge of SES compared with BMS (P=0.006).Degertekin et al20 addressed coronary remodeling after SES implantation compared with BMS. In this study, the lumen loss at the proximal edge was similar between SES and BMS, −3.6% versus −2.8% (P=NS). However, the mechanism for lumen loss at the proximal edge was different in the SES versus BMS. Plaque increase was observed in the SES at the proximal edge but not in the BMS (11.8% versus −4.5%, P=0.054), and vessel remodeling was positive in the SES and negative in the BMS (1.7% versus −6.4%, P=0.057). At the distal edge, tendency toward enlargement due to positive remodeling was observed in the lumen of SES, while lumen loss was detected in the BMS (1.5% versus −8.0%, P=NS).In serial IVUS assessments from the DiabeDES trial,14 there were no significant changes in vessel, lumen, or plaque volumes at the proximal edge of SES, while significant lumen enlargement (P=0.037) was observed at distal edge at follow up. In a much smaller study, Asano et al21 evaluated the edge effect of SES in only 33 lesions and found lumen decreases with significant P&M increases (P<0.01) without significant vessel remodeling (P=0.9).Some SES trials have specific patient populations. Diabetic patients were studied with serial IVUS in the DIABETES (Diabetes and Sirolimus-Eluting Stent) trial,22 and their outcomes when treated with SES versus BMS were compared. The SES diabetic patients demonstrated a significant increase in vessel and lumen volume at both the proximal and distal edges of the SES. Conversely, in the BMS group, negative vessel remodeling resulted in reduced lumen volume.In a substudy of patients with acute myocardial infarction, serial IVUS from the MISSION intervention study23 evaluated the edge effect of SES compared with BMS. This is the only study in which stent edge was defined as the segment 5 to 10 mm distal or proximal to the stent instead of the conventional definition of 0 to 5 mm. At the proximal edge, negative remodeling and lumen reduction were observed in both SES and BMS. However, at the distal edge, enlargement of lumen with positive remodeling was observed in SES, while lumen reduction with negative remodeling was observed in BMS. Change of mean lumen area during follow up was significantly different between BMS versus SES (−0.8±1.6 versus 0.2±0.8, P=0.04).In summary, these IVUS studies demonstrated no negative stent edge effects in SES compared with BMS. Across most studies, lumen enlargement (or the lack of lumen reduction as compared with BMS) occurred in the distal edge of SES because of positive remodeling. In general, there was lumen reduction at proximal edge of the stent (in both BMS and SES) in most of these studies.Zotarolimus-Eluting StentsThe analysis is limited to the zotarolimus-eluting Endeavor stent. The Resolute platform was not included.The ENDEAVOR III trial24 compared the efficacy and safety of ZES and SES (Table 2). There was no difference at baseline and at follow up, and between the groups at stent edge segments. At the proximal stent edge of ZES, there was an increase in lumen volume with plaque reduction, while lumen volume did not change at the distal stent edge. There was no statistical difference in vessel response of stent edge segments between ZES and SES.Table 2. Edge Effect of Sirolimus-Eluting StentsStudy NameFirst AuthorPatients, nFollow Up, mProximal Edge Up to 5 mmDistal Edge Up to 5 mmAnalysisEEM, mmP&M, mmLumen, mmEEM, mmP&M, mmLumen, mmFIM registry*Degertekin434 or 6↓↑↓↑↑↑VolumeE-SIRIUS†Hoffmann318N/AN/A↓N/AN/A↓VolumeN/A‡Degertekin245.5↑↑↓↑↑↑VolumeDiabeDES§Jensen408↓ ↑ 1–2 3–5↓ ↑ 1,3 2,4,5↑ ↓ 1 2–5↑↓ 1–4 5↑↓ 1 2↑ 1–5mm by mmN/A∥Asano339↓ 1–5↑ 1–5↓ 1–5↓ 1–5↑ 1–5↓ 1–5mm by mmDIABETES**Jiménez- Quevedo759↑↑↑↑↑↑VolumeMission††Atary209↓N/A↓↑N/A↑Volume 5–10 mmEndeavor III‡‡Miyazawa428→↑↓↓↑↓VolumeArrows indicate an increase or decrease from baseline to follow-up.EEM indicates external elastic membrane; P&M, plaque and media.*Data from Degertekin M, et al.18†Data from Hoffmann R, et al.19‡Data from Degertekin M, et al.20§Data from Jensen LO, et al.14∥Data from Asano T, et al.21**Data from Jiménez-Quevedo P, et al.22††Data from Atary JZ, et al.23‡‡Data from Miyazawa A, et al.24Serial IVUS data along each millimeter of the stent edge is available in a subset of the Endeavor II trial,25 which compared the efficacy and safety of ZES with BMS. In volumetric analysis of the stent edge during follow up, significant lumen reduction (proximal P<0.0001, distal P=0.01) due to negative remodeling (proximal P 1 year is unknown. In 1 study, it was reported that no significant change in lumen or vessel volume was observed in either proximal or distal edges of SES from 6 months to 20 months.30This review indicates the beneficial effect of the drug on a DES, especially in the distal edge, and suggests the effect differs among DES type. IVUS assessment of stent edge should be continued in next generation DES to extend our knowledge about the distal benefit of DES.DisclosuresNone.FootnotesCorrespondence to Dr Neil J. Weissman, Washington Hospital Center, 100 Irving Street, NW, Suite EB 5123, Washington DC 20010. E-mail neil.j.[email protected]netReferences1. Morice MC, Serruys PW, Sousa JE, Fajadet J, Ban Hayashi E, Perin M, Colombo A, Schuler G, Barragan P, Guagliumi G, Molnàr F, Falotico R; RAVEL Study Group. 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Circulation. 2002; 106:1610–1613.LinkGoogle Scholar Previous Back to top Next FiguresReferencesRelatedDetailsCited By Hideo-Kajita A, Garcia-Garcia H, Haude M, Joner M, Koolen J, Ince H, Abizaid A, Toelg R, Lemos P, von Birgelen C, Christiansen E, Wijns W, Neumann F, Kaiser C, Eeckhout E, Teik L, Escaned J, Azizi V, Kuku K, Ozaki Y, Dan K and Waksman R (2019) First Report of Edge Vascular Response at 12 Months of Magmaris, A Second-Generation Drug-Eluting Resorbable Magnesium Scaffold, Assessed by Grayscale Intravascular Ultrasound, Virtual Histology, and Optical Coherence Tomography. A Biosolve-II Trial Sub-Study, Cardiovascular Revascularization Medicine, 10.1016/j.carrev.2019.02.019, 20:5, (392-398), Online publication date: 1-May-2019. 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April 2012Vol 5, Issue 2 Advertisement Article InformationMetrics © 2012 American Heart Association, Inc.https://doi.org/10.1161/CIRCINTERVENTIONS.111.966259PMID: 22511739 Manuscript receivedOctober 18, 2011Manuscript acceptedJanuary 12, 2012Originally publishedApril 1, 2012 Keywordsdrug-eluting stentintravascular ultrasoundedge effectPDF download Advertisement SubjectsImagingStent