Short- and Intermediate-Term Results of
            <sup>32</sup>
            P Radioactive β-Emitting Stent Implantation in Patients With Coronary Artery Disease

Albiero, Remo; Adamian, Milena; Kobayashi, Nobuyuky; Ambrosi, Antonio; Vaghetti, Marco; Mario, Carlo Di; Colombo, Antonio

doi:10.1161/01.cir.101.1.18

Cited by 153 publications

(82 citation statements)

References 33 publications

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“…Whereas in-stent measurements of follow-up MLD have been relied on for the evaluation of virtually all bare metal stents to date, 5,6,37 the observation of an exuberant renarrowing at the margins of stents, despite a therapeutic effect within the stent observed in early brachytherapy trials 38 and some pilot DES trials, 39 termed "edge effect" or "candy-wrapper restenosis," led to inclusion of the zones proximal and distal to the stent for analysis. When the binary variable angiographic restenosis is used, the more inclusive in-segment analysis has the attractive ability to capture events that occur only at the edges, whereas the in-stent analysis does not.…”

Section: In-stent Versus In-segment Late Lossmentioning

confidence: 99%

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

et al. 2005

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Background-Observed rates of restenosis after drug-eluting stenting are low (Ͻ10%). Identification of a reliable and powerful angiographic end point will be useful in future trials. Methods and Results-Late loss (postprocedural minimum lumen diameter minus 8-month minimum lumen diameter) was measured in the angiographic cohorts of the SIRIUS (nϭ703) and E-SIRIUS (nϭ308) trials. Two techniques, the standard normal approximation and an optimized power transformation, were used to predict binary angiographic restenosis rates and compare them with observed restenosis rates. The mean in-stent late loss observed in the SIRIUS trial was 0.17Ϯ0.45 mm (sirolimus) versus 1.00Ϯ0.70 mm (control). If a normal distribution was assumed, late loss accurately estimated in-stent binary angiographic restenosis for the control arm (predicted 35.4% versus observed 35.4%) but underestimated it in the sirolimus arm (predicted 0.6% versus observed 3.2%). Power transformation improved the reliability of the estimate in the sirolimus arm (predicted 3.2% [CI 1.0% to 6.7%]) with similar improvements in the E-SIRIUS trial (predicted 4.0% [CI 1.2% to 7.0%] versus observed 3.9%). In the sirolimus-eluting stent arm, in-stent late loss correlated better with target-lesion revascularization than in-segment late loss (c-statisticϭ0.915 versus 0.665). Conclusions-Because distributions of late loss with a low mean are right-skewed, the use of a transformation improves the accuracy of predicting low binary restenosis rates. Late loss is monotonically correlated with the probability of restenosis and yields a more efficient estimate of the restenosis process in the era of lower binary restenosis rates.

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Section: In-stent Versus In-segment Late Lossmentioning

confidence: 99%

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

et al. 2005

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“…This combined approach has been used successfully in intracoronary brachytherapy. 4,5 Late thrombosis and edge stenosis (the "candy wrapper effect") are potential complications that may limit the effectiveness of this approach. 5,6 Pharmacological inhibitors of neointimal hyperplasia, like paclitaxel, represent an alternative to radiation therapy.…”

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confidence: 99%

“…4,5 Late thrombosis and edge stenosis (the "candy wrapper effect") are potential complications that may limit the effectiveness of this approach. 5,6 Pharmacological inhibitors of neointimal hyperplasia, like paclitaxel, represent an alternative to radiation therapy. 7,8 Paclitaxel (Taxol) is a derivatized diterpenoid that exerts an antineoplastic effect by interfering with cell microtubule function.…”

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Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

et al. 2001

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Background-Despite limiting elastic recoil and late vascular remodeling after angioplasty, coronary stents remain vulnerable to restenosis, caused primarily by neointimal hyperplasia. Paclitaxel, a microtubule-stabilizing drug, has been shown to inhibit vascular smooth muscle cell migration and proliferation contributing to neointimal hyperplasia. We tested whether paclitaxel-coated coronary stents are effective at preventing neointimal proliferation in a porcine model of restenosis. Methods and Results-Palmaz-Schatz stents were dip-coated with paclitaxel (0, 0.2, 15, or 187 g/stent) by immersion in ethanolic paclitaxel and evaporation of the solvent. Stents were deployed with mild oversizing in the left anterior descending coronary artery (LAD) of 41 minipigs. The treatment effect was assessed 4 weeks after stent implantation.

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“…Although intracoronary radiation therapy is one of the promising biological approaches, recent studies have also raised the concerns of lumen narrowing in the adjacent reference segments and increased late thrombosis rates. 1,2 The local delivery of antiproliferative drugs with a drug-eluting stent is considered a potential alternative to provide both a biological and mechanical solution. 3,4 Preclinical studies have shown that local administration of paclitaxel (Taxol), a microtubular inhibitor, or its analogues significantly reduces smooth muscle cell migration and proliferation for months after balloon angioplasty or stenting.…”

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confidence: 99%

Novel Drug-Delivery Stent

Honda¹,

Grube²,

Fuente³

et al. 2001

Circulation

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Background-The aim of this study was to use serial intravascular ultrasound (IVUS) to evaluate the long-term effect of stent-based 7-hexanoyltaxol (QP2, a taxane analogue) delivery on neointimal tissue growth within the stent and on vessel dimensions at the adjacent reference segments. Methods and Results-Serial IVUS analyses (immediately after intervention and at follow-up at 8.3 months) were performed in 15 native coronary lesions treated with the QuaDS-QP2 stent. IVUS measurements were performed at 8 cross-sections in each target segment (4 cross-sections within the stent and 2 cross-sections in each reference segment). At baseline, no significant plaque protrusion or thrombus was detected in the target segment. Mild incomplete stent apposition and edge dissection were observed in one and two cases, respectively. Percent expansion of the stent (minimum stent area/average reference lumen area) was 96.0Ϯ21.7%. At follow-up, mean neointimal area within the stent was 1.2Ϯ1.3 mm 2 , and mean cross-sectional narrowing (neointimal area/stent area) was 13.6Ϯ14.9%. At the vessel segments immediately adjacent to the stent, a significant increase in plaque area (1.9Ϯ2.6 mm 2 , Pϭ0.001) was observed, but vessel area remained unchanged. However, no patients showed clinically significant in-stent or edge restenosis (diameter stenosis Ն50%) during the follow-up period. Conclusions-The first human experience with the new drug-delivery stent showed a minimal amount of neointimal proliferation in the stented segment. Late lumen loss at the reference sites adjacent to the stent was acceptable and predominantly due to plaque proliferation.

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Short- and Intermediate-Term Results of ³² P Radioactive β-Emitting Stent Implantation in Patients With Coronary Artery Disease

Cited by 153 publications

References 33 publications

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

Novel Drug-Delivery Stent

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Short- and Intermediate-Term Results of 32 P Radioactive β-Emitting Stent Implantation in Patients With Coronary Artery Disease

Cited by 153 publications

References 33 publications

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

Relationship of Late Loss in Lumen Diameter to Coronary Restenosis in Sirolimus-Eluting Stents

Paclitaxel Stent Coating Inhibits Neointimal Hyperplasia at 4 Weeks in a Porcine Model of Coronary Restenosis

Novel Drug-Delivery Stent

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Product

Resources

About

Short- and Intermediate-Term Results of ³² P Radioactive β-Emitting Stent Implantation in Patients With Coronary Artery Disease