Literature DB >> 16212452

Feasibility trial of carotid stenting with and without an embolus protection device.

Kenneth Ouriel1, Mark H Wholey, Pierre Fayad, Barry T Katzen, Patrick Whitlow, Michael Frentzko, Richard E Kuntz, Lawrence Wechsler, Nelson Hopkins, Lowell Satler, Greg Mishkel, Jay S Yadav.   

Abstract

PURPOSE: To evaluate the feasibility of stenting and cerebral protection in patients with carotid bifurcation disease.
METHODS: Carotid stenting with self-expanding nitinol stents was evaluated in 261 patients (157 men; mean age 70.9+/-9.7 years, range 41-90) treated at 33 clinical sites. Among these patients, 141 (54.3%) were symptomatic, and 71 (27.2%) had postendarterectomy restenotic lesions. An embolus protection device became available in the latter third of the study. The primary endpoint of the study was the 30-day composite occurrence of major adverse clinical events (all deaths, strokes, or myocardial infarctions [MI]). At 1 year, the endpoint included all deaths, strokes, or MIs at 30 days, plus all deaths or ipsilateral strokes between 31 days and 1 year.
RESULTS: SMART stents were placed in 147 (56%) patients and Precise stents in 107 (41%); 7 (3%) patients were treated with non-study stents. Lesion success, defined as <30% postprocedural residual stenosis, was achieved in 249 (95%). An AngioGuard filter was used in 85 patients; of 90 filters employed, 78 (87%) were successfully deployed and retrieved. Visible material was noted in 42 (54%) retrieved filters. One (0.4%) stent thrombosis occurred at <30 days, and no restenotic lesions >80% were noted in up to 1 year of follow-up. At 30 days, stroke occurred in 16 (6.1%) patients, MI in 1 (0.4%), and 2 (0.8%) patients died. The 30-day rate of stroke, MI, or death was 6.9%. Major ipsilateral stroke occurred in 4 (1.5%) patients between 0 and 30 days; no new major ipsilateral strokes were noted up to 1 year. By Kaplan-Meier analysis, the 1-year risk of stroke, MI, or death was 10.9%+/-2.0%. The 1-year risk of major ipsilateral stroke was significantly lower in patients treated with embolus protection devices (0.0% versus 2.3%, p=0.05).
CONCLUSIONS: The use of nitinol self-expanding stents in the carotid position appears to be a safe and efficacious alternative for the treatment of carotid bifurcation disease. The addition of embolus protection devices may diminish the risk of postprocedural major ipsilateral strokes.

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Year:  2005        PMID: 16212452     DOI: 10.1583/05-1573.1

Source DB:  PubMed          Journal:  J Endovasc Ther        ISSN: 1526-6028            Impact factor:   3.487


  4 in total

Review 1.  Interventional procedures for atherothrombosis: pathology of retrieved material.

Authors:  Annalisa Angelini; Mila Della Barbera; Gaetano Thiene
Journal:  Heart       Date:  2007-10       Impact factor: 5.994

2.  Initial experience of using the filter protection device during carotid artery stenting in Japan.

Authors:  Katsutoshi Takayama; Hiroyuki Nakagawa; Satoru Iwasaki; Toshiaki Taoka; Toshiteru Miyasaka; Kaoru Myouchin; Takeshi Wada; Masahiko Sakamoto; Akio Fukusumi; Ichiro Nakagawa; Shinichiro Kurokawa; Kimihiko Kichikawa
Journal:  Radiat Med       Date:  2008-08-03

3.  Cerebral ischemia detected with diffusion-weighted MR imaging after protected carotid artery stenting: comparison of distal balloon and filter device.

Authors:  Suk Jung Kim; Hong Gee Roh; Pyoung Jeon; Keon Ha Kim; Kwang Ho Lee; Hong Sik Byun; Won Jin Moon; Gyeong Moon Kim; Young Wook Kim; Dong Ik Kim
Journal:  Korean J Radiol       Date:  2007 Jul-Aug       Impact factor: 3.500

Review 4.  Clinical Outcomes of Second- versus First-Generation Carotid Stents: A Systematic Review and Meta-Analysis.

Authors:  Adam Mazurek; Krzysztof Malinowski; Kenneth Rosenfield; Laura Capoccia; Francesco Speziale; Gianmarco de Donato; Carlo Setacci; Christian Wissgott; Pasqualino Sirignano; Lukasz Tekieli; Andrey Karpenko; Waclaw Kuczmik; Eugenio Stabile; David Christopher Metzger; Max Amor; Adnan H Siddiqui; Antonio Micari; Piotr Pieniążek; Alberto Cremonesi; Joachim Schofer; Andrej Schmidt; Piotr Musialek
Journal:  J Clin Med       Date:  2022-08-17       Impact factor: 4.964

  4 in total

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