PURPOSE: The authors compared the immediate, mid-term and long-term effectiveness of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients. MATERIALS AND METHODS:From October 2006 to November 2009, 48 patients with non-insulin-dependent diabetes mellitus (DM) and an indication for percutaneous revascularisation of the femoropopliteal arteries were randomly assigned to treatment with angioplasty or cryoplasty. The following parameters were analysed and compared between the two groups: immediate technical success (residual stenosis <30%) and distal run-off as assessed on postprocedural angiography, and degree of restenosis and distal run-off at 6 and 12 months, as assessed with either colour Doppler ultrasound (CDUS) or digital subtraction angiography (DSA). RESULTS: Treatment with angioplasty revealed a significant superiority in procedural technical success (p=0.04), a significant reduction in the degree of restenosis at 6 months (p=0.02) and a significant increase in the distal run-off at 6 (p=0.005) and 12 (p=0.01) months. CONCLUSIONS:Conventional angioplasty is more effective than cryoplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabetic patients and provides better immediate, mid-term and long-term results.
RCT Entities:
PURPOSE: The authors compared the immediate, mid-term and long-term effectiveness of cryoplasty and conventional angioplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabeticpatients. MATERIALS AND METHODS: From October 2006 to November 2009, 48 patients with non-insulin-dependent diabetes mellitus (DM) and an indication for percutaneous revascularisation of the femoropopliteal arteries were randomly assigned to treatment with angioplasty or cryoplasty. The following parameters were analysed and compared between the two groups: immediate technical success (residual stenosis <30%) and distal run-off as assessed on postprocedural angiography, and degree of restenosis and distal run-off at 6 and 12 months, as assessed with either colour Doppler ultrasound (CDUS) or digital subtraction angiography (DSA). RESULTS: Treatment with angioplasty revealed a significant superiority in procedural technical success (p=0.04), a significant reduction in the degree of restenosis at 6 months (p=0.02) and a significant increase in the distal run-off at 6 (p=0.005) and 12 (p=0.01) months. CONCLUSIONS: Conventional angioplasty is more effective than cryoplasty for treating stenotic-occlusive lesions of the femoropopliteal arteries in diabeticpatients and provides better immediate, mid-term and long-term results.
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