Aim: The aim of this study was to evaluate safety and efficacy of directional atherectomy with the Silver HawkTM device as first line treatment for in-stent restenosis of the femoropopliteal artery.
Methods: Over a period of 1.5 years in-stent restenosis of the femoropopliteal artery in 35 lesions (34 legs, 33 patients) was primarily treated with directional atherectomy. Primary endpoint was treatment success (<50% residual stenosis) and the absence of complications. Secondary endpoint was target lesion patency after 3, 6 and 12 month assessed by duplexsonography.
Results: Mean patient age was 70 years (SD+/-10). 74 % were claudicants (Rutherford 2-3), 26% had CLI (Ruther-ford (4-5). 45% were diabetics, 82% had a history of arterial hypertension and nicotine abuse. Mean lesion length was 108 mm (SD+/-102 mm). Treatment success with atherectomy alone was achieved in 86% with additional PTA (43%) success increased to 97%. Adjunctive stent implantation was necessary in 11% of the cases. Post interventional ABI increased from 0.54 (+/-0.26) to 0.77 (+/-0.26). The rate of minor complication was 3% (1/34) and the rate of major complication was 18% (6/34), mainly due to distal embolization. Target lesion patency at 3 month was 86.2%, at 6 month 68% and at 12 month 25%.
Conclusions: Although atherectomy of in-stent restenosis as a first line treatment yields a high initial success rate with a low requirement for adjunctive PTA and stent implantation, long term patency rates are low. In our study the theoretical advantage of avoiding barotauma did not result in prevention of recurrent intimal hyperplasia.