2010
DOI: 10.1007/s00270-010-9915-x
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Cryoplasty Versus Conventional Balloon Angioplasty of the Femoropopliteal Artery in Diabetic Patients: Long-Term Results from a Prospective Randomized Single-Center Controlled Trial

Abstract: 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. Primar… Show more

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Cited by 53 publications
(31 citation statements)
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“…A meta-analysis of head-to-head RCTs of paclitaxel-coated balloons (THUNDER, FEMPAC, LEVANT I & PACIFIER) with standard uncoated balloon angioplasty have shown a significant reduction of angiographic binary restenosis (OR = 0.26) and target lesion revascularization (OR = 0.22) at 6 months [7]. Balloon cryoplasty seems to have limited effectiveness [74,75]. Of note, there is limited cost-utility or cost-effectiveness data about any of the previously mentioned techniques in the femoropopliteal artery.…”
Section: Postprocedural Follow-up Carementioning
confidence: 99%
“…A meta-analysis of head-to-head RCTs of paclitaxel-coated balloons (THUNDER, FEMPAC, LEVANT I & PACIFIER) with standard uncoated balloon angioplasty have shown a significant reduction of angiographic binary restenosis (OR = 0.26) and target lesion revascularization (OR = 0.22) at 6 months [7]. Balloon cryoplasty seems to have limited effectiveness [74,75]. Of note, there is limited cost-utility or cost-effectiveness data about any of the previously mentioned techniques in the femoropopliteal artery.…”
Section: Postprocedural Follow-up Carementioning
confidence: 99%
“…Despite observational data showing lower rate of stenting after cryoplasty, this could not be validated in two small randomized trials, where the rate of stenting after cryoplasty remained comparable to PTA. 16,17 The main benefit of altering compliance appears to be in less dissection and bailout stenting. In the Calcium 360 trial 7 and the PTA versus atherectomy plus adjunctive PTA study, 6 TLR was not statistically reduced despite less dissection and stenting although TLR rate trended less in the debulking arm.…”
mentioning
confidence: 99%
“…Another randomised study reported similar conclusions from a cohort of diabetic patients who underwent a single cryoplasty treatment, showing better results than PTA in the immediate, short and long-term in the femoropopliteal arteries [8]. However, in other randomised studies of femoropopliteal lesions, cryoplasty and PTA had the same TLR at mid-term [9][10][11], failing to demonstrate an overwhelming benefit of cryoplasty over PTA. A recent retrospective record review of reinterventions for in-stent restenosis in the femoropopliteal segment showed that recurrent stenosis-free survival was significantly lower in the cryoplasty cohort at short-term and mid-term postdilation [12].…”
Section: Introductionmentioning
confidence: 74%