Document Detail


Short- and intermediate-term results of (32)P radioactive beta-emitting stent implantation in patients with coronary artery disease: The Milan Dose-Response Study.
MedLine Citation:
PMID:  10618299     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: Radioactive (32)P beta-emitting stents have been shown to reduce intrastent neointimal hyperplasia in a substantial dose-related manner in the animal model. The aim of this dose-response study was to evaluate, in the clinical setting, the safety and efficacy at 6-month follow-up of this approach to reducing restenosis. METHODS AND RESULTS: A total of 122 (32)P radioactive beta-emitting stents (initially the Palmaz-Schatz and later the BX Isostent) with an activity level of 0.75 to 3.0 microCi (group 1), 3.0 to 6.0 microCi (group 2), and 6.0 to 12.0 microCi (group 3) were implanted in 91 lesions in 82 patients. There were no procedural events. At 6-month follow-up, no deaths had occurred, and only 1 patient had stent thrombosis. Pure intrastent binary restenosis was 16% in group 1, 3% in group 2, and 0% in group 3. However, intralesion restenosis was 52% in group 1, 41% in group 2, and 50% in group 3. CONCLUSIONS: The use of (32)P radioactive beta-emitting stents in patients with CAD is feasible. At 6-month follow-up, intrastent neointimal hyperplasia was reduced in a dose-related manner. However, in the 3 groups, intralesion restenosis was high because of a high late lumen loss in the reference segments at the stent edges, possibly as a result of a low activity level of radiation at the edges of the stent combined with an aggressive approach to stenting. We called this "edge effect" the "candy wrapper."
Authors:
R Albiero; M Adamian; N Kobayashi; A Amato; M Vaghetti; C Di Mario; A Colombo
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Publication Detail:
Type:  Clinical Trial; Controlled Clinical Trial; Journal Article    
Journal Detail:
Title:  Circulation     Volume:  101     ISSN:  0009-7322     ISO Abbreviation:  Circulation     Publication Date:    2000 Jan 4-11
Date Detail:
Created Date:  2000-02-24     Completed Date:  2000-02-24     Revised Date:  2009-11-19    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  18-26     Citation Subset:  AIM; IM    
Affiliation:
EMO Centro Cuore Columbus, Milan, Italy. albire@micronet.it
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MeSH Terms
Descriptor/Qualifier:
Analysis of Variance
Angioplasty, Balloon
Beta Particles
Brachytherapy / methods*
Coronary Angiography
Coronary Artery Bypass
Coronary Disease / radiography,  radiotherapy*
Female
Follow-Up Studies
Humans
Hyperplasia
Italy
Male
Middle Aged
Phosphorus Radioisotopes / therapeutic use*
Platelet Aggregation Inhibitors / therapeutic use
Radiotherapy Dosage
Stents* / adverse effects
Ticlopidine / therapeutic use
Tunica Intima / pathology,  radiation effects
Chemical
Reg. No./Substance:
0/Phosphorus Radioisotopes; 0/Platelet Aggregation Inhibitors; 55142-85-3/Ticlopidine
Comments/Corrections
Comment In:
Circulation. 2000 Jan 4-11;101(1):3-7   [PMID:  10618295 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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