Radioactive Stents Delay but Do Not Prevent In-Stent Neointimal Hyperplasia

Kay, Ian; Wardeh, Alexander J.; Kozuma, Ken; Foley, David P.; Knook, A.H.M.; Thury, Attila; Sianos, George; Giessen, Willem J. van der; Levendag, Peter C.; Serruys, Patrick W.

doi:10.1161/01.cir.103.1.14

Cited by 66 publications

(35 citation statements)

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“…14 Therefore, our findings provide considerable reassurance with regard to persistent inhibition of late restenosis or rebound hyperplasia, such as was previously observed with radioactive stents. 8 In fact, minimal hyperplasia in humans up to 2 years after the procedure constitutes the first evidence that behavior in humans is at variance with the porcine model, where 90-day data actually demonstrate the recurrence of considerable NIH (Andrew J. Carter, unpublished data). For the first time in interventional cardiology, a new antirestenosis therapy performs better in humans than in the animal models.…”

Section: Discussionmentioning

confidence: 99%

“…1,2,3 Histological follow-up in the porcine model, however has indicated that late neointimal hyperplasia can recur at 90 and 180 days (Andrew J. Carter, DO, unpublished data, 2001). Thus, there are sufficient concerns about delayed healing with consequent risks of late restenosis 4 and thrombosis, 5 late malapposition, 6 edge effect, 7 and, on the other hand, delayed restenosis, 8 to warrant additional late follow-up catheterization. The objective of this study was to determine angiographic, intravascular ultrasound (IVUS), and clinical outcome up to 2 years after implantation of sirolimus-eluting stents in de novo coronary lesions.…”

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Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation

et al. 2002

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Background-Early results of sirolimus-eluting stent implantation showed a nearly complete abolition of neointimal hyperplasia. The question remains, however, whether the early promising results will still be evident at long-term follow-up. The objective of our study was to evaluate the efficiency of sirolimus-eluting stent implantation for up to 2 years of follow-up. Methods and Results-Fifteen patients with de novo coronary artery disease were treated with 18-mm sirolimus-eluting Bx-Velocity stents (Cordis) loaded with 140 g sirolimus/cm 2 metal surface area in a slow release formulation. Quantitative angiography (QCA) and intravascular ultrasound (IVUS) were performed according to standard protocol. Sirolimus-eluting stent implantation was successful in all 15 patients. During the in-hospital course, 1 patient died of cerebral hemorrhage after periprocedural administration of abciximab, and 1 patient underwent repeat stenting after 2 hours because of edge dissection that led to acute occlusion. Through 6 months and up to 2 years of follow-up, no additional events occurred. QCA analysis revealed no significant change in stent minimal lumen diameter or percent diameter stenosis, and 3-dimensional IVUS showed no significant deterioration in lumen volume. In 2 patients, additional stenting was performed because of significant lesion progression remote from the sirolimus-eluting stent. Conclusion-Sirolimus-eluting stents showed persistent inhibition of neointimal hyperplasia for up to 2 years of follow-up.

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Section: Discussionmentioning

confidence: 99%

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Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation

et al. 2002

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“…57,62 Concern regarding this phenomenon has prompted many clinical trials investigating stents eluting antimitotic agents to treat enrolled patients with oral antithrombotic agents for up to 6 months after implantation of these stents. Lack of a long-term effect on restenosis as described with radioactive stents 63 may also become apparent in the future. The added cost of these stents may, at least initially, limit their use to patients at high risk for in-stent stenosis and is an issue yet to be addressed.…”

Section: Complications and Controversiesmentioning

confidence: 99%

Coated Stents for the Prevention of Restenosis: Part II

2002

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T his is the second part of a 2-part article that reviews the literature on coated stents and their effects on in-stent restenosis after percutaneous coronary intervention (PCI). Part I of this review discussed the pathophysiology of in-stent restenosis, specific stent coatings, and animal studies investigating coated stents. Part II discusses nonrandomized studies and clinical trials in humans. Studies in humans have examined stents coated with biocompatible materials and drug-eluting stents. Complications and controversies associated with this new technology are also addressed. Human StudiesThe risk of developing in-stent restenosis is related to a variety of factors, both clinical and procedural. [1][2][3][4][5][6][7] On the basis of these risk factors, patients enrolled in both nonrandomized studies and clinical trials have been classified as having a high, intermediate, or low risk of restenosis. Therefore, the binary restenosis rates (Ͼ50% diameter stenosis angiographically) and major adverse cardiac event (MACE) rates in human studies vary greatly depending on the overall risk profile of patients enrolled in these studies. Non-Randomized Studies Stents Coated with Biocompatible MaterialsThe biocompatibility of stents coated with several materials, including carbon, gold, silicon carbide, and phosphorylcholine, has been investigated in humans. The Carbostent (Sorin Biomedica Cardio) is a metal stent coated with a carbon film that is thought to be less thrombogenic than uncoated steel stents. 8 Antoniucci et al 9 investigated the long-term biocompatibility of the Carbostent in a group of 112 patients with an intermediate risk of developing restenosis. Six-month follow-up revealed low MACE and restenosis rates of 12% and 11%, respectively. A second study in another group of 112 patients at high risk for restenosis resulted in a MACE rate of 20% and a binary restenosis rate of 25% by 6 months. 10 These results suggest that the Carbostent is well tolerated in vivo and possibly inhibits neointimal hyperplasia, especially in high-risk patients (Table 1).Gold has been touted as a biocompatible material and has been thought to be ideal for coating coronary stents because of its radio-opaque properties. 1 Two studies evaluating the biocompatibility of gold-coated stents suggested equivalency with uncoated steel stents. 11,12 However, two other studies concluded that these stents may increase neointimal hyperplasia compared with uncoated stents, although patients at a higher risk for restenosis were enrolled. 13,14 Follow-up angiography at 6 months demonstrated a relatively high lumen late loss (postintervention minimum luminal diameter minus the minimum luminal diameter at follow-up) and diameter stenosis in both studies (Table 1). Overall, there have been conflicting results in observational studies examining goldcoated stents, and the restenosis rates seem to be no better than those obtained with uncoated steel stents.Silicon carbide is an inert semiconductor that can be coated onto prosthetic surfaces and has be...

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“…However, undergoing radiation brachytherapy or using radioactive stents have also shown that proliferation at the stent edges may be associated with higher-than-expected restenosis rates at the stent margins. As more evidence supported that radioactive stents delayed but do not prevented in-stent neointimal hyperplasia [19], scientists gradually paid much more attention on the novel designs of drug eluting stents.…”

Section: Bare Metal Stentsmentioning

confidence: 99%

Current status of research and application in vascular stents

Yang

Maitz

2013

Chin. Sci. Bull.

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Cardiovascular diseases have been the leading cause of death in modern society. Using vascular stents to treat these coronary and peripheral artery diseases has been one of the most effective and rapidly adopted medical interventions. During the twenty-five years' development of vascular stents, revolutionary cardiovascular stents like drug eluting stents and endothelial progenitor cells capture stents have emerged. In this review, the evolution of vascular stents is summarized, aiming to provide a glimpse into the future of vascular stents. Advanced designs, focusing on the investigations of new substrates, new platforms, new drugs and new biomolecules are currently under evaluation with promising clinical studies. The concept of "time sequence functional stent" has been raised in this paper. It presents anti-proliferative properties in the first phase after implantation and subsequently support endothelialization. It also shows long-term inertness without release of toxic ions or toxic degradation products. The success of this concept is briefly presented with a clinical study in this model stents.

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Radioactive Stents Delay but Do Not Prevent In-Stent Neointimal Hyperplasia

Abstract: Neointimal proliferation is delayed rather than prevented by radioactive stent implantation. Clinical outcome 1 year after the implantation of stents with an initial activity of 6 to 12 microCi is not favorable when compared with conventional stenting.

Cited by 66 publications

References 18 publications

Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation

Persistent Inhibition of Neointimal Hyperplasia After Sirolimus-Eluting Stent Implantation

Coated Stents for the Prevention of Restenosis: Part II

Current status of research and application in vascular stents

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