Purpose: The main problem with the treatment of arterial stenoses by percutaneous transluminal angioplasty (PTA) or stent implantation is the relatively high restenosis rate. The objective of this prospective single-center study was to evaluate a mechanical rotational catheter (Straub Rotarex®) for its safety and efficacy in the treatment of in-stent reocclusions.
Materials and methods: 78 patients with a mean age of 64.2 ± 8.3 years (42 - 85) were treated by means of the Rotarex® catheter. All patients had in-stent reocclusions of the femoropopliteal arteries. The preinterventional Rutherford stage was on average 3.36 (2 - 5). The mean lesion length was 14.7 cm (6 - 30 cm). The ankle-brachial index (ABI) was determined prior to and after the intervention, as well as after 12 months. An additional follow-up was performed using color-coded duplex sonography.
Results: The technical success rate was 97.4 % (76 / 78). In 52 / 76 patients (68.4 %), adjunctive balloon dilation was performed, and 8 / 76 (10.5 %) patients required a stent implantation. Clinically, there was an increase in the ankle-brachial index from 0.61 ± 0.17 to 0.85 ± 0.15 post-interventionally. After 12 months, it was 0.78 ± 0.16, and the average Rutherford stage fell to 1.65 (1 - 3). During the follow-up observation period, there were 14 (18.4 %) restenoses. Two dissections after Rotarex were recorded as peri-interventional complications. No distal embolizations were observed. There were no amputations or deaths during the entire period of the study.
Conclusion: The recanalization of in-stent reocclusions of femoropopliteal arteries using the Rotarex® system is safe and effective. The low rate of restenosis at 12 months appears to be promising.
© Georg Thieme Verlag KG Stuttgart · New York.