Clinical Trial
Comparative Study
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Percutaneous peripheral atherectomy of femoropopliteal stenoses using a new-generation device: six-month results from a single-center experience.

PURPOSE: To report the early and 6-month results after atherectomy of femoropopliteal lesions using a new atherectomy device compatible with a 7-F sheath.

METHODS: Fifty-two patients (36 men; mean age 67+/-7 years) with stable, chronic lower limb occlusive disease were enrolled prospectively in a study of percutaneous directional atherectomy using the SilverHawk Atherectomy Catheter. The 71 femoropopliteal stenoses were grouped for analysis according to pathology: 30 (42%) primary stenoses, 27 (38%) native vessel restenoses, and 14 (20%) in-stent restenoses. The overall average stenosis length was 48+/-64 mm (range 10-300). There were more diabetics in the primary lesion cohort, whereas the lesion length of the in-stent restenoses was nearly twice as long as the other groups.

RESULTS: After atherectomy alone, residual stenosis was < or =50% in 68 (96%) lesions and < or =30% in 54 (76%). Additional balloon angioplasty was used in 41 (58%) lesions, primarily to smooth the arterial contour; stents were implanted in 4 (6%) arteries. Acute results after atherectomy and additional therapy were identical for the 3 groups (mean residual stenosis 15% in primary lesions, 8% in restenoses, and 14% in in-stent lesions). At the beginning of the study, 5 cases of tissue embolism were successfully treated with aspiration (device modification solved this problem). Restenosis rates after 6 months were not significantly lower in primary lesions (27%) compared with the other groups (41% for restenoses and 36% for in-stent restenoses). Reintervention after 6 months was also lowest for primary lesions (20% versus 37% for restenoses and 29% for in-stent lesions; p=NS). The ankle-brachial index was significantly improved after 6 months in all groups. At the 6-month follow-up, >80% of all patients were symptom free or had no lifestyle-limiting claudication.

CONCLUSIONS: Short and medium-length femoropopliteal lesions can be treated successfully and safely in most cases with this new atherectomy catheter. Technical and 6-month clinical outcomes seem to favor primary lesions compared with restenoses.

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