One-year outcome of percutaneous rotational atherectomy with aspiration in infrainguinal peripheral arterial occlusive disease: the multicenter pathway PVD trial.

PURPOSE: To report a safety and efficacy study of a novel rotational atherectomy system with aspiration capabilities for the treatment of infrainguinal arterial lesions.

METHODS: From February 2006 to January 2007, 172 patients (88 women; mean age 72 years, range 51-93; 47% diabetics) with Rutherford class 1-5 lower limb ischemia were enrolled at 9 study sites. Inclusion criteria were atherosclerotic stenoses >70% and up to 10 cm long in the femoropopliteal segment or up to 3 cm long in the infrapopliteal vessels (reference vessel diameter 3.0-5.0 mm). In the study, 210 lesions (mean length 2.7 cm) were treated with the Pathway PV System, including total occlusions (31%), lesions with a moderate to high calcium score (51%), and post-angioplasty (non-stent) restenotic lesions (15%). The primary study endpoint was the 30-day major adverse event (MAE) rate.

RESULTS: Device success was 99% (208/210 lesions). MAE at 30 days was 1% (2 preplanned amputations). Clinically driven target lesion revascularization rates at 6 and 12 months were 15% (25/172) and 26% (42/162), respectively. The 1-year restenosis rate was 38.2% based on duplex imaging. The ankle-brachial index increased significantly from 0.59+/-0.21 at baseline to 0.82+/-0.27 (p<0.05) at 12 months. Mean Rutherford class improved from 3.0+/-0.9 at baseline to 1.5+/-1.3 at 1 year (p<0.05).

CONCLUSION: The use of the Pathway PV System in atherosclerotic lesions appears to be safe and effective in improving stenosis severity, even in the presence of challenging lesion conditions. Vessel patency following intervention appears to be good up to 12 months, and these results translate into clinical benefit.