Background: Cryoballoon angioplasty (CP) for superficial femoral artery (SFA) occlusive disease has attracted attention as an adjunct to primary high-pressure balloon angioplasty (HP) and as an alternative to primary stenting in the SFA. Study Design: A retrospective review from 1999 to 2005 of patients with chronic critical ischemia because of complex SFA lesions (TransAtlantic Inter-Society Consensus [TASC] C and D) was performed. Those patients treated with either standard HP or CP were examined. Vessels treated by primary stenting or atherectomy were excluded. Results: Eight-five patients with 93 (67%) limbs underwent HP and 39 patients with 45 (33%) limbs underwent CP. Rest pain, tissue loss, or both, were the presenting symptoms in 49% of the HP group and 69% of the CP group. There was no significant difference in the final technical success rate between HP and CP, but significantly more stents were required in HP (75% versus 22%, HP versus CP; p < 0.05). Stenosis rather than occlusion is the more common mode of failure after CP (HP: 68% versus 32%; CP: 38% versus 62%). Despite this, there was no change in 1-year primary (66 ± 6% versus 69 ± 9%; HP versus CP; mean ± SEM), assisted (78 ± 5% versus 80 ± 8%), or secondary patencies (78 ± 5% versus 80 ± 8%) between the 2 modalities. Freedom from recurrent symptoms and limb salvage for critical ischemia were equivalent. Conclusions: CP substantially increases the number of TASC C and D lesions for which balloon angioplasty alone is effective. Adjuvant stent usage is markedly reduced without a decrease in cumulative patency. Cryoballoon angioplasty should be considered a viable alternative for sole therapy for complex lesions of the SFA.
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