Cryoplasty versus conventional balloon angioplasty of the femoropopliteal artery in diabetic patients: long-term results from a prospective randomized single-center controlled trial.
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.
Spiliopoulos
Stavros
S
Department of Diagnostic and Interventional Radiology, Angiography Suite, School of Medicine, Patras University Hospital, Patras, Rion, 26504, Greece. stavspiliop@upatras.gr
Katsanos
Konstantinos
K
Karnabatidis
Dimitris
D
Diamantopoulos
Athanasios
A
Kagadis
George C
GC
Christeas
Nikolaos
N
Siablis
Dimitris
D
D000368:Aged; D000369:Aged, 80 and over; D000800:Angioplasty, Balloon / Q000379:methods*; D001157:Arterial Occlusive Diseases / Q000000981:diagnostic imaging / Q000628:therapy*; D016001:Confidence Intervals; D003452:Cryosurgery / Q000379:methods*; D003922:Diabetes Mellitus, Type 1 / Q000175:diagnosis / Q000628:therapy; D003924:Diabetes Mellitus, Type 2 / Q000175:diagnosis / Q000628:therapy; D003925:Diabetic Angiopathies / Q000000981:diagnostic imaging / Q000628:therapy*; D005260:Female; D005263:Femoral Artery; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011150:Popliteal Artery; D016016:Proportional Hazards Models; D011446:Prospective Studies; D011859:Radiography; D018570:Risk Assessment; D013997:Time Factors; D016896:Treatment Outcome; D014654:Vascular Patency / Q000502:physiology