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Calcific lesion and CTO are a big challenge in diabetic patients with critical limb ischemia. Nowadays drug eluting devices failed to improve significantly the outcomes of these patients, due to the inability of drug to penetrate media-intima calcium and consequent jeorpardization effect. In this study ultrasound plasty associated to local Paclitaxel delivery was compared with drug eluting ballon for treatment of femoral/popliteal disease in patients with critical limb ischemia.
The single center, single blinded randomized trial included 56 patients with critical limb ischemia randomly assigned to treatment in 2 groups: 28 patients(control group) were treated with DEB, and 28 patients(study group) were treated with ultrasound energy followed by local administration of Paclitaxel in liquid mixture with iopromide-370 at 1microgram/mm3 concentration. In the study group, mean lesion length was 168.8mm and 21 patients had calcifications. In the control group, mean lesion length was 164mm and 23 patients had calcifications.
No adverse procedural events were observed. 2 patients in study group and 1 patient in control group were lost at 24 months follow up. 3 Patients in study group and 4 patient in control group died at 24 months follow-up. At 24 months in the study group, the rate of TLR was 18.2% (4/22) and the rate of amputation was 0% (0/22). In the control group, the rate of TLR was 52.2% (12/23) and the rate of amputation was 20% (5/23).
Ultrasound plasty associated to Paclitaxel improve patency and reduced the need for TLR and amputations.
ENDOVASCULAR: Peripheral Vascular Disease and Intervention