Document Detail

Three-year clinical and angiographic follow-up after intracoronary radiation : results of a randomized clinical trial.
MedLine Citation:
PMID:  10653825     Owner:  NLM     Status:  MEDLINE    
BACKGROUND: Although several early trials indicate treatment of restenosis with radiation therapy is safe and effective, the long-term impact of this new technology has been questioned. The objective of this report is to document angiographic and clinical outcome 3 years after treatment of restenotic stented coronary arteries with catheter-based (192)Ir. METHODS AND RESULTS: A double-blind, randomized trial compared (192)Ir with placebo sources in patients with previous restenosis after coronary angioplasty. Over a 9-month period, 55 patients were enrolled; 26 were randomized to (192)Ir and 29 to placebo. At 3-year follow-up, target-lesion revascularization was significantly lower in the (192)Ir group (15. 4% versus 48.3%; P<0.01). The dichotomous restenosis rate at 3-year follow-up was also significantly lower in (192)Ir patients (33% versus 64%; P<0.05). In a subgroup of patients with 3-year angiographic follow-up not subjected to target-lesion revascularization by the 6-month angiogram, the mean minimal luminal diameter between 6 months and 3 years decreased from 2.49+/-0.81 to 2.12+/-0.73 mm in (192)Ir patients but was unchanged in placebo patients. CONCLUSIONS: The early clinical benefits observed after treatment of coronary restenosis with (192)Ir appear durable at late follow-up. Angiographic restenosis continues to be significantly reduced in (192)Ir-treated patients, but a small amount of late loss was observed between the 6-month and 3-year follow-up time points. No events occurred in the (192)Ir group to suggest major untoward effects of vascular radiotherapy. At 3-year follow-up, vascular radiotherapy continues to be a promising new treatment for restenosis.
P S Teirstein; V Massullo; S Jani; J J Popma; R J Russo; R A Schatz; E M Guarneri; S Steuterman; K Sirkin; D A Cloutier; M B Leon; P Tripuraneni
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Publication Detail:
Type:  Clinical Trial; Journal Article; Multicenter Study; Randomized Controlled Trial    
Journal Detail:
Title:  Circulation     Volume:  101     ISSN:  1524-4539     ISO Abbreviation:  Circulation     Publication Date:  2000 Feb 
Date Detail:
Created Date:  2000-02-18     Completed Date:  2000-02-18     Revised Date:  2004-11-17    
Medline Journal Info:
Nlm Unique ID:  0147763     Medline TA:  Circulation     Country:  UNITED STATES    
Other Details:
Languages:  eng     Pagination:  360-5     Citation Subset:  AIM; IM    
Division of Cardiovascular Diseases, Scripps Clinic, La Jolla, CA 92037, USA.
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MeSH Terms
Angioplasty, Balloon*
Brachytherapy* / mortality
Coronary Angiography*
Coronary Disease / mortality,  radiotherapy*,  therapy
Disease-Free Survival
Double-Blind Method
Follow-Up Studies
Graft Occlusion, Vascular
Iridium Radioisotopes / therapeutic use*
Myocardial Infarction / surgery,  therapy
Survival Analysis
Reg. No./Substance:
0/Iridium Radioisotopes; 0/Placebos
Comment In:
Circulation. 2000 Feb 1;101(4):350-1   [PMID:  10653822 ]

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

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