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      Recurrent carotid in-stent restenosis treated with a Paclitaxel-Eluting Balloon: case report and review of literature Translated title: Restenose carotídea intra-stent recorrente tratada com drug-eluting balloon: caso clínico e revisão da literatura

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          Abstract

          Introduction: Carotid artery stenting (CAS) is a valid alternative to carotid endarterectomy with proper indications. In-stent restenosis (ISR) is a possible complication and there are multiple therapeutic options for severe ISR (>70%). The use of drug-eluting balloons (DEB) has increasing evidence as a new endovascular treatment for ISR. The authors report a case of recurrent ISR treated with a DEB. Case report: Male patient, 67 years-old, with a history of cervical radiation in 2006. In 2007, he had a stroke in the territory of the right internal carotid artery (ICA). The duplex ultrasound (DUS) showed right ICA occlusion and left ICA stenosis >70%. He underwent left CAS under fi lter protection, without complications. He was kept as an outpatient and in 2009 he presented ISR >70%. The patient was treated with re-stenting, without residual stenosis and had an uneventful course. In 2012, DUS revealed recurrent ISR >70%. Angioplasty with a paclitaxel-eluting balloon was performed, with distal cerebral protection, good imaging and hemodynamic results and an uneventful course. At 6 months of follow-up, the patient has no complications and no ISR documented by ultrasound. Conclusions: The use of DEB in the treatment of ISR after CAS is an emerging strategy with promising results.

          Translated abstract

          Introdução: O stenting carotídeo (CAS) é uma alternativa válida à endarteriectomia carotídea com indicações bem definidas. A restenose intra-stent (RIS) é uma complicação possível e são múltiplas as opções terapêuticas para o tratamento da restenose severa (> 70%). O uso de drug-eluting balloons (DEB) tem evidência crescente como nova terapêutica endovascular em casos de RIS após CAS. Os autores descrevem um caso clínico de angioplastia com DEB por RIS recorrente. Caso clínico: Doente de 67 anos, submetido a radioterapia cervical em 2006. Em 2007, apresentou AVC no território da artéria carótida interna (ACI) direita. O eco-Doppler demonstrou oclusão ACI direita e estenose ACI esquerda > 70%. Foi submetido a CAS da ACI esquerda com protecção cerebral, sem complicações. Seguido em consulta externa e em 2009 o eco-Doppler revelou RIS > 70%. Foi submetido a re-stenting, sem estenose residual e sem intercorrências. Em 2012, documentada por eco-Doppler recorrência de RIS > 70%. Foi tratado com DEB, sob protecção cerebral, com bom resultado imagiológico e hemodinâmico e sem eventos neurológicos. O doente apresenta 6 meses de seguimento sem RIS demonstrada por eco-Doppler. Conclusão: O uso de DEB no tratamento de RIS após CAS é uma estratégia emergente, com resultados promissores.

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          Most cited references38

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          Local delivery of paclitaxel to inhibit restenosis during angioplasty of the leg.

          Drug-eluting stents reduce restenosis in coronary arteries, but clinical trials have failed to prove their efficacy in peripheral arteries. We investigated the use of paclitaxel-coated angioplasty balloons and paclitaxel dissolved in the angiographic contrast medium during angioplasty of the leg. In a small, multicenter trial, we randomly assigned 154 patients with stenosis or occlusion of a femoropopliteal artery to treatment with standard balloon catheters coated with paclitaxel, uncoated balloons with paclitaxel dissolved in the contrast medium, or uncoated balloons without paclitaxel (control). The primary end point was late lumen loss at 6 months. The mean (+/-SD) age of the patients was 68+/-8 years, 24% were smokers, and 49% had diabetes. Twenty-seven percent of the lesions were total occlusions, and 36% were restenotic lesions. The mean lesion length was 7.4+/-6.5 cm. There were no significant differences in baseline characteristics between the groups. There were no adverse events attributable to the paclitaxel-coated balloons. At 6 months, the mean late lumen loss was 1.7+/-1.8 mm in the control group, as compared with 0.4+/-1.2 mm (P<0.001) in the group treated with paclitaxel-coated balloons and 2.2+/-1.6 mm (P=0.11) in the group treated with paclitaxel in the contrast medium. The rate of revascularization of target lesions at 6 months was 20 of 54 (37%) in the control group, 2 of 48 (4%) in the group treated with paclitaxel-coated balloons (P<0.001 vs. control), and 15 of 52 (29%) in the group treated with paclitaxel in the contrast medium (P=0.41 vs. control); at 24 months, the rates increased to 28 of 54 (52%), 7 of 48 (15%), and 21 of 52 (40%), respectively. Use of paclitaxel-coated angioplasty balloons during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. No significant benefit is seen with the use of a paclitaxel-containing contrast medium. (ClinicalTrials.gov number, NCT00156624 [ClinicalTrials.gov].). Copyright 2008 Massachusetts Medical Society.
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            Inhibition of restenosis in femoropopliteal arteries: paclitaxel-coated versus uncoated balloon: femoral paclitaxel randomized pilot trial.

            The success of percutaneous intervention in peripheral arterial disease is limited by restenosis. The aim of the present pilot study was to evaluate a novel method of local drug delivery. This randomized multicenter study with blinded reading enrolled 87 patients in Rutherford class 1 to 4 with occlusion or hemodynamically relevant stenosis, restenosis, or in-stent restenosis of femoropopliteal arteries. Treatment was performed by either conventional uncoated or paclitaxel-coated balloon catheters. The primary end point was late lumen loss at 6 months. Secondary end points included restenosis rate, ankle brachial index, Rutherford class, target lesion revascularization, and tolerance up to >18 months. Before intervention, there were no significant differences in lesion characteristics such as reference diameter (5.3+/-1.1 versus 5.2+/-1.0 mm), degree of stenosis (84+/-11% versus 84+/-16%), proportion of restenotic lesions (36% versus 33%), and mean lesion length (5.7 cm [0.8 to 22.6 cm] versus 6.1 cm [0.9 to 19.3 cm]) between treatment groups. The 6-month follow-up angiography performed in 31 of 45 and 34 of 42 patients showed less late lumen loss in the coated balloon group (0.5+/-1.1 versus 1.0+/-1.1 mm; P=0.031). The number of target lesion revascularizations was lower in the paclitaxel-coated balloon group than in control subjects (3 of 45 versus 14 of 42 patients; P=0.002). Improvement in Rutherford class was greater in the coated balloon group (P=0.045), whereas the improvement in ankle brachial index was not different. The difference in target lesion revascularizations between treatment groups was maintained up to >18 months. No adverse events were assessed as related to balloon coating. In this pilot trial, paclitaxel balloon coating caused no obvious adverse events and reduced restenosis in patients undergoing angioplasty of femoropopliteal arteries.
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              Restenosis after carotid artery stenting and endarterectomy: a secondary analysis of CREST, a randomised controlled trial.

              In the Carotid Revascularization Endarterectomy versus Stenting Trial (CREST), the composite primary endpoint of stroke, myocardial infarction, or death during the periprocedural period or ipsilateral stroke thereafter did not differ between carotid artery stenting and carotid endarterectomy for symptomatic or asymptomatic carotid stenosis. A secondary aim of this randomised trial was to compare the composite endpoint of restenosis or occlusion. Patients with stenosis of the carotid artery who were asymptomatic or had had a transient ischaemic attack, amaurosis fugax, or a minor stroke were eligible for CREST and were enrolled at 117 clinical centres in the USA and Canada between Dec 21, 2000, and July 18, 2008. In this secondary analysis, the main endpoint was a composite of restenosis or occlusion at 2 years. Restenosis and occlusion were assessed by duplex ultrasonography at 1, 6, 12, 24, and 48 months and were defined as a reduction in diameter of the target artery of at least 70%, diagnosed by a peak systolic velocity of at least 3·0 m/s. Studies were done in CREST-certified laboratories and interpreted at the Ultrasound Core Laboratory (University of Washington). The frequency of restenosis was calculated by Kaplan-Meier survival estimates and was compared during a 2-year follow-up period. We used proportional hazards models to assess the association between baseline characteristics and risk of restenosis. Analyses were per protocol. CREST is registered with ClinicalTrials.gov, number NCT00004732. 2191 patients received their assigned treatment within 30 days of randomisation and had eligible ultrasonography (1086 who had carotid artery stenting, 1105 who had carotid endarterectomy). In 2 years, 58 patients who underwent carotid artery stenting (Kaplan-Meier rate 6·0%) and 62 who had carotid endarterectomy (6·3%) had restenosis or occlusion (hazard ratio [HR] 0·90, 95% CI 0·63-1·29; p=0·58). Female sex (1·79, 1·25-2·56), diabetes (2·31, 1·61-3·31), and dyslipidaemia (2·07, 1·01-4·26) were independent predictors of restenosis or occlusion after the two procedures. Smoking predicted an increased rate of restenosis after carotid endarterectomy (2·26, 1·34-3·77) but not after carotid artery stenting (0·77, 0·41-1·42). Restenosis and occlusion were infrequent and rates were similar up to 2 years after carotid endarterectomy and carotid artery stenting. Subsets of patients could benefit from early and frequent monitoring after revascularisation. National Institute of Neurological Disorders and Stroke and Abbott Vascular Solutions. Copyright © 2012 Elsevier Ltd. All rights reserved.
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                Author and article information

                Contributors
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Role: ND
                Journal
                ang
                Angiologia e Cirurgia Vascular
                Angiol Cir Vasc
                Sociedade Portuguesa de Angiologia e Cirurgia Vascular (Lisboa )
                1646-706X
                December 2013
                : 9
                : 4
                : 163-167
                Affiliations
                [1 ] Centro Hospitalar de Vila Nova de Gaia/Espinho Portugal
                [2 ] University of Porto Portugal
                Article
                S1646-706X2013000400007
                e27dcc65-9419-4bdc-a8a8-17ba6d0cbd9d

                http://creativecommons.org/licenses/by/4.0/

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                SciELO Portugal

                Self URI (journal page): http://www.scielo.mec.pt/scielo.php?script=sci_serial&pid=1646-706X&lng=en
                Categories
                PERIPHERAL VASCULAR DISEASE

                Cardiovascular Medicine
                Carotid artery stenosis,Carotid artery stenting,In-stent restenosis,Drug-eluting balloon,Paclitaxel,Estenose carotídea,Stenting carotídeo,Restenose intra-stent

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