Abstract No. 231: Featured Abstract

Abstract

To evaluate efficacy, safety and patency of Cryoplasty versus “Plain Old Balloon Angioplasty” (POBA) for popliteal arterial occlusive disease. Patients with de-novo stenoses or occlusions of the popliteal artery were randomized to Cryoplasty or conventional balloon angioplasty as the initial treatment strategy. Primary objective was target lesion patency at 9 months. Secondary endpoint was anatomical treatment success (<30% residual stenosis, absence of hemodynamically relevant dissection/ recoil, no need for stent placement). F/U with ABI and CCDS was performed at 3, 6, 9 and 15 months, angiography was performed for cases of suspected restenosis. 77 pts. (mean-age 72,2 years; range, 50-94) were enrolled so far, 35 randomized to Cryoplasty, 42 to POBA. Demografics, risk factors, clinical stage of disease and lesion details are comparable in both groups, with the majority of patients being claudicants (Cryo: 74,3%; POBA: 81%). Mean number of Cryoplasty performances per lesion was 2 ± 0,6. Mean inflation time of conventional angioplasty was 2,9 ± 1,3 minutes. On intention-to-treat basis, treatment success was 29%(10/35) for Cryoplasty versus 52% (22/42) for POBA including long term dilatation (p=0,035). Rate of relevant dissection after Cryoplasty alone was 37 %, versus 26% following POBA (p=0,14). In 60% (21/35) of Cryoplasty patients additional long-term PTA with a conventional balloon was performed. Rate of stent placement for persistent dissection and/or residual stenosis was 29% after Cryoplasty (including long-term dilation) and 40% after POBA (p=0,28). Target lesion patency at 9 months and is 63,3 % for POBA and 75,7 % for Cryoplasty, however results are not significant (p=0,18). Cryoplasty of the popliteal artery alone shows a lower anatomical success when compared to POBA. Combined with optional long-term PTA, however, stent placement is not needed more often. There is a trend towards higher patency after Cryoplasty, but long-term follow-up has to be awaited. This study also demonstrates that modern recanalization techniques in the popliteal artery achieve patency rates comparable to angioplasty in the femoral artery.