Document Detail

Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial.
MedLine Citation:
PMID:  20574796     Owner:  NLM     Status:  MEDLINE    
The purpose of this study was to investigate the immediate and long-term results of cryoplasty versus conventional balloon angioplasty in the femoropopliteal artery of diabetic patients. Fifty diabetic patients (41 men, mean age 68 years) were randomized to cryoplasty (group CRYO; 24 patients with 31 lesions) or conventional balloon angioplasty (group COBA; 26 patients with 34 lesions) of the femoropopliteal artery. Technical success was defined as <30% residual stenosis without any adjunctive stenting. Primary end points included technical success, primary patency, binary in-lesion restenosis (>50%), and freedom from target lesion recanalization. Cox proportional hazards regression analysis was performed to adjust for confounding factors of heterogeneity. In total, 61.3% (19 of 31) in group CRYO and 52.9% (18 of 34) in group COBA were de novo lesions. More than 70% of the lesions were Transatlantic Inter-Society Consensus (TASC) B and C in both groups, and 41.4% of the patients in group CRYO and 38.7% in group COBA suffered from critical limb ischemia. Immediate technical success rate was 58.0% in group CRYO versus 64.0% in group COBA (p = 0.29). According to 3-year Kaplan-Meier estimates, there were no significant differences with regard to patient survival (86.8% in group CRYO vs. 87.0% in group COBA, p = 0.54) and limb salvage (95.8 vs. 92.1% in groups CRYO and COBA, respectively, p = 0.60). There was a nonsignificant trend of increased binary restenosis in group CRYO (hazard ratio [HR] 1.3; 95% CI 0.6-2.6, p = 0.45). Primary patency was significantly lower in group CRYO compared with group COBA (HR 2.2; 95% CI 1.1-4.3, p = 0.02). Significantly more repeat intervention events because of recurrent symptoms were required in group CRYO (HR 2.5; 95% CI 1.2-5.3, p = 0.01). Cryoplasty was associated with lower primary patency and more clinically driven repeat procedures after long-term follow-up compared with conventional balloon angioplasty.
Stavros Spiliopoulos; Konstantinos Katsanos; Dimitris Karnabatidis; Athanasios Diamantopoulos; George C Kagadis; Nikolaos Christeas; Dimitris Siablis
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial     Date:  2010-06-24
Journal Detail:
Title:  Cardiovascular and interventional radiology     Volume:  33     ISSN:  1432-086X     ISO Abbreviation:  Cardiovasc Intervent Radiol     Publication Date:  2010 Oct 
Date Detail:
Created Date:  2010-09-07     Completed Date:  2011-01-10     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  8003538     Medline TA:  Cardiovasc Intervent Radiol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  929-38     Citation Subset:  IM    
Department of Diagnostic and Interventional Radiology, Angiography Suite, School of Medicine, Patras University Hospital, Patras, Rion, 26504, Greece.
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MeSH Terms
Aged, 80 and over
Angioplasty, Balloon / methods*
Arterial Occlusive Diseases / radiography,  therapy*
Confidence Intervals
Cryosurgery / methods*
Diabetes Mellitus, Type 1 / diagnosis,  therapy
Diabetes Mellitus, Type 2 / diagnosis,  therapy
Diabetic Angiopathies / radiography,  therapy*
Femoral Artery
Follow-Up Studies
Middle Aged
Popliteal Artery
Proportional Hazards Models
Prospective Studies
Risk Assessment
Time Factors
Treatment Outcome
Vascular Patency / physiology

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

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