Document Detail


Batroxobin for prevention of restenosis in diabetic patients after infrapopliteal arterial angioplasty: a small randomized pilot trial.
MedLine Citation:
PMID:  20831989     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
BACKGROUND: We designed a small randomized clinical trial to prospectively test the hypothesis that batroxobin is more effective than aspirin alone to prevent restenosis in patients with diabetes undergoing angioplasty of infrapopliteal arteries.
METHODS: After a successful angioplasty, a total of 52 diabetic patients with symptomatic infrapopliteal obstructions were randomized to either the treated group (n = 26) or the control group (n = 26). Patients in the treated group received 5 IU batroxobin through an intravenous drip once every alternate day, for a total of six doses. The primary end point was restenosis and reocclusion, which was documented by magnetic resonance angiography or duplex scanning at 12-month follow-up. The clinical symptoms relief and ankle-brachial index (ABI) were compared before and after the procedure, and during follow-up. Kaplan-Meier curves were constructed to evaluate restenosis or reocclusion-free, limb salvage, and amputation-free rates.
RESULTS: Restenosis and reocclusion occurred in 22.0% and 34.5% lesions in the treated and the control group, respectively (p = 0.0307). Statistical differences were observed between the ABI before the angioplasty procedure(p < 0.05) and the ABI at the 12-month follow-up (p = 0.0094) of the two groups. Clinical symptoms improvement and tissue healing occurred in 23 and 19 patients in the batroxobin group and the control group, respectively (p = 0.0544). Twelve months after angioplasty, Kaplan-Meier analysis showed that the restenosis and reocclusion-free rate was 74.0% and 54.8%, the limb salvage rate was 96.2% and 92.3%, and the amputation-free rate was 84.6% and 84.6%, in the treated and control group, respectively.
CONCLUSION: This pilot trial revealed that batroxobin usage was effective in preventing restenosis and reocclusion after infrapopliteal arterial angioplasty, and it might provide better clinical symptoms relief; however, it did not report preferable limb salvage or amputation-free rates.
Authors:
Jue Wang; Yue-Qi Zhu; Fang Liu; Ming-Hua Li; Jun-Gong Zhao; Hua-Qiao Tan; Jian-Bo Wang; Ying-Sheng Cheng; Pei-Lei Zhang
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial    
Journal Detail:
Title:  Annals of vascular surgery     Volume:  24     ISSN:  1615-5947     ISO Abbreviation:  Ann Vasc Surg     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-13     Completed Date:  2011-01-11     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8703941     Medline TA:  Ann Vasc Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  876-84     Citation Subset:  IM    
Copyright Information:
Copyright © 2010 Annals of Vascular Surgery Inc. Published by Elsevier Inc. All rights reserved.
Affiliation:
Department of Radiology, Sixth Affiliated People's Hospital, Medical School of Shanghai Jiao Tong University, Shanghai, People's Republic of China.
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MeSH Terms
Descriptor/Qualifier:
Aged
Amputation
Angioplasty* / adverse effects
Ankle Brachial Index
Arterial Occlusive Diseases / diagnosis,  therapy*
Aspirin / therapeutic use
Batroxobin / administration & dosage,  therapeutic use*
China
Constriction, Pathologic
Diabetic Angiopathies / diagnosis,  therapy*
Disease-Free Survival
Double-Blind Method
Female
Fibrinolytic Agents / administration & dosage,  therapeutic use*
Humans
Infusions, Intravenous
Kaplan-Meier Estimate
Magnetic Resonance Angiography
Male
Middle Aged
Pilot Projects
Popliteal Artery* / pathology,  ultrasonography
Prospective Studies
Recurrence / prevention & control
Regression Analysis
Risk Assessment
Risk Factors
Severity of Illness Index
Time Factors
Treatment Outcome
Ultrasonography, Doppler, Duplex
Chemical
Reg. No./Substance:
0/Fibrinolytic Agents; 50-78-2/Aspirin; EC 3.4.21.-/Batroxobin

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