Immediate and intermediate-term results of optical coherence tomography guided atherectomy in the treatment of peripheral arterial disease: initial results from the VISION trial

Abstract

Background: Long-term patency rates for percutaneous peripheral arterial interventions are suboptimal. Optical coherence tomography ( OCT) guided atherectomy may yield superior patency by optimizing plaque removal while preserving the tunica media and adventitia. Methods: The VISION study is a multicenter prospective study of patients with peripheral arterial disease undergoing OCT guided atherectomy with the Pantheris (TM) device. In 11 patients enrolled in a single center, we report procedural and clinical outcomes, at 30 days and 6 months. Results: The mean age was 63+/- 11 years and 73% ( n= 8) were men. The target lesion was in the superficial femoral artery in 82% ( n = 9) of the patients. Mean stenosis severity was 87% +/- 10% and mean lesion length was 39 +/- 31 mm. Procedural success was observed in all patients with no device related complications. Mean post-atherectomy stenosis was 18% +/- 15%. Almost all excised tissue consisted of intimal plaque ( 94%). At 30 days, significant improvements in Rutherford class, VascuQoL scores and ABI were observed, 0.9 +/- 0.8 vs. 3.1 +/- 0.7 ( p= 0.01), 4.9 +/- 1.9 vs. 3.6 +/- 1.5 ( p= 0.03) and 1.04 +/- 0.19 vs. 0.80 +/- 0.19 ( p < 0.01) respectively. At 6 months, there were significant improvements in Rutherford class ( 1.0+/- 1.0 vs. 3.1+/- 0.7, p= 0.01) and ABI ( 0.93 +/- 0.19 versus 0.80 +/- 0.19, p = 0.02) but not in VascuQoL scores ( 3.7 +/- 1.4 versus 3.6 +/- 1.5, p = 0.48). Target lesion revascularization occurred in 18% ( n= 2) of the patients. Conclusion: OCT guided atherectomy resulted in high procedural success, no device related complications and encouraging results up to 6 months. Histological analysis suggested little injury to the media and adventitia. Larger studies are needed to confirm the efficacy of this approach. (C) 2016 Elsevier Inc. All rights reserved.