Abstract No. 227: Directional Atherectomy for In-Stent Restenosis of the Femoropopliteal Artery: Results of a Pilot Study

Abstract

Initial results of a prospective non- randomized single center study to evaluate safety and effectiveness of directional atherectomy as a primary treatment modality for femoro-popliteal instent restenosis. 12 patients (70,8 ± 9,8 years) with restenosis following stent placement into the femoropopliteal artery were treated primarily with excisional atherectomy using the Silver Hawk™ device. Distal filter protection was not used. Primary objective is anatomical treatment success with residual stenosis < 30% or hemodynamically relevant dissection in the absence of complications. Secondary objective is target vessel patency at 6 and 12 months. Follow-up consists of clinical evaluation, ABI measurements and color coded duplex sonography. Angiography in performed in case of suspected restenosis. Most patients (11/12, 92%) were claudicants. Stents had been implanted for a mean period of 8,5 (± 8,2) months before the secondary procedure. Maximum grade of restenosis was 92,2% (±7,7), mean lesion length was 11,6 cm (±8,2). Length of stented vessel segments was 14,8 cm (±5,0) with one case of stent fracture. On intention-to-treat basis anatomical treatment success of excisional atherectomy alone was 67% (8/12). In half of the cases additional balloon angioplasty was performed for residual stenosis or proximal and distal de-novo lesions. Additional stents were implanted in 2/12 cases (16,7%). Overall treatment success of the revascularization procedure was 100%. Doppler index improved from 0,44 (±0,3) to 0,76 (±0,3). There was one case of distal embolization, managed by aspiration thrombectomy (1/12; 8,3%). One patient experienced reocclusion of the treated vessel before 30 days. Patency rates at 6 months are pending and will be presented. Directional atherectomy as a primary treatment modality for instent restenosis of the femoropopliteal artery is safe with promising initial success and low complication rates. If the theoretical advantage of removing neointimal tissue without repeated barotrauma also translates into a clinical benefit has to be proven by long-term follow-up.