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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. [ABSTRACT FROM AUTHOR]

Purpose: To report the results from a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) vs. drug-eluting stents (DES) in long infrapopliteal lesions. Materials and Methods: From December 2011 to January 2013, 50 patients were randomized to undergo infrapopliteal angioplasty using paclitaxel-coated balloons (n=25, Group PCB) or primary drug-eluting stenting (n=25, Group DES). Inclusion criteria were patients with Rutherford 3-6 with angiographically documented infrapopliteal disease and a minimum lesion length of 70 mm. Primary endpoints were 6-month angiographic binary restenosis rate assessed by quantitative vessel analysis (QVA). Secondary endpoints included immediate device success and 6-month target lesion revascularization (TLR). Results: Baseline variables were equally distributed between the two groups with the exception of age (Group PCB: 67.58 vs. Group DES 75.27, p=0.03). Lesion length was 127±46.5mm for Group DES vs.148±56.7mm for Group PCB (p=0.14). There was no significant difference in treated lesion lengths (159 mm DCB vs. 129 DES, p = 0.11). Immediate success was 25/25 (100%) for DES group vs. 24/25 (96%) in PCB group (p=0.14). In total, 30 lesions were treated in Group DES vs. 25 in group PCB. Six-month binary restenosis was statistically significantly in favor of DES (28% Group DES vs. 57.9% group PCB, p=0.02). There was no statistical difference in TLR (2/27 vs. 3/12, p=0.21). Conclusion: Drug eluting stents resulted in significantly better restenosis rates compared to DCB in long infrapopliteal lesions after 6 moths follow-up, with no statistical difference in TLR and limb salvage rates. [Copyright &y& Elsevier]

Purpose: Τo report the results of a prospective randomized controlled trial comparing paclitaxel-coated balloons (PCB) versus plain balloon angioplasty (PBA) for the treatment of failing arterio-venous fistulae (AVF). Materials and Methods: Within 17 months, 40 patients with a failing AVF were randomly selected to undergo either PCB dilation (group PCB, n = 20) or PBA (group PBA, n = 20). Enrollment criteria included a clinical diagnosis of dysfunctional AVF circuit attributed to at least one stenotic lesion. Study primary endpoints included technical success (residual target lesion stenosis <30% without flow-limiting dissection) and target lesion primary patency (absence of a >50% target lesion binary restenosis associated with failing dialysis access). Secondary endpoints included circuit patency and complication rates. Results: There were no significant differences in baseline variables between the two groups. Technical success was 100% for both groups. Primary patency of treatment site and access circuit were statistically significant in favor of the PCB (PCB group 6/20 vs. 2/20 PTA group; p<0.05 and PCB group: 4/20 vs. 0/20 PTA group; p<0.05 respectively). No minor or major complications were observed. Conclusion: Paclitaxel-coated balloons improved target lesion and dialysis access circuit primary patency of dysfunctional arterio-venous fistulae [Copyright &y& Elsevier]