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    
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.
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
Related Documents :
23769779 - Intraocular pressure after penetrating keratoplasty and descemet's stripping automated ...
18572369 - Cryoplasty therapy of the superficial femoral and popliteal arteries: a reappraisal aft...
16252079 - Pta versus carbofilm-coated stents in infrapopliteal arteries: pilot study.
17675549 - Comparison of classical and non-classical cardiovascular risk factors influencing the p...
9244069 - Intermittent claudication should not be treated by surgery.
24596819 - The significance and factors related to bladder outlet obstruction in pelvic floor dysf...
18569029 - Ischemic colitis in postmenopausal women taking hormone replacement therapy.
24389229 - Safety and efficacy of renal denervation as a novel treatment for ventricular tachycard...
18940539 - Laser: a review.
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.
Department of Radiology, Sixth Affiliated People's Hospital, Medical School of Shanghai Jiao Tong University, Shanghai, People's Republic of China.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Angioplasty* / adverse effects
Ankle Brachial Index
Arterial Occlusive Diseases / diagnosis,  therapy*
Aspirin / therapeutic use
Batroxobin / administration & dosage,  therapeutic use*
Constriction, Pathologic
Diabetic Angiopathies / diagnosis,  therapy*
Disease-Free Survival
Double-Blind Method
Fibrinolytic Agents / administration & dosage,  therapeutic use*
Infusions, Intravenous
Kaplan-Meier Estimate
Magnetic Resonance Angiography
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
Reg. No./Substance:
0/Fibrinolytic Agents; 50-78-2/Aspirin; EC 3.4.21.-/Batroxobin

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

Previous Document:  Long-term outcome of endovascular popliteal artery aneurysm repair.
Next Document:  Fate of popliteal artery aneurysms after exclusion and bypass.