VISION: OCT-Guided Atherectomy Safe, Effective for PAD Intervention

Atherectomy guided by optical coherence tomography (OCT) using a novel catheter in patients with peripheral artery disease undergoing percutaneous intervention met the primary safety and efficacy endpoints of the VISION study, researchers reported during a Featured Clinical Research session. 

VISION is a global investigational device exemption trial approved by the FDA. Arne G. Schwindt, MD, of St. Franziskus Hospital, Münster, Germany, and colleagues enrolled 130 patients eligible for percutaneous PAD intervention who received OCT-guided atherectomy using the Pantheris catheter (Avinger). The catheter-based system combines directional atherctomy with real-time intravascular visualization to remove plaque from blocked arteries. The mean age of patients was 67 years, 55% were men and mean BMI was 28. Most also presented with hypertension requiring intervention and other vascular disease and reported being smokers.

The primary efficacy endpoint of residual stenosis ≤ 50% following atherectomy was met, with a performance goal of > 87% and adjudicated efficacy of 96.3%. In a subcohort of 93 patients with evaluable follow-up data, 6-month ankle brachial index improved from baseline (P = .013), as did Rutherford classification in the majority of patients (P < .0001).

The primary safety endpoint of freedom from major adverse events through six months was also met in the subcohort (Figure). The adjudicated safety rate was 21.5%, with no dissections, perforations or late aneurysms reported.

Tissue analysis indicated that 1% of tissue extracted during atherectomy was adventitia, which Schwindt said “confirms the precision of the device.”

OCT-guided atherectomy detected a longer treatment zone compared with fluoroscopy at baseline, Schwindt said, both for analysis of all lesions (73.3 mm with OCT vs. 53.6 mm with fluoroscopy) and separate analysis of CTO (107.1 mm vs. 81.1 mm) and non-CTO lesions (64.8 mm vs. 46.3 mm; P < .0001 for all).

More than half of lesions were treated with atherectomy alone, with adjunctive therapy required for the remaining 44%. The rate of bail-out stenting was low in high-grade stenosis (4%) and CTOs (3%). Throughout the cohort, arterial stenosis decreased from 78.7 ± 15.2% at baseline to 22.2 ± 9.8% after atherectomy and adjunctive treatment.

According to Schwindt, the complete dataset from VISION will be available within a month and presented in November at the VIVA conference. “We expect the results to be even more favorable,” he added.

Disclosures:

• Schwindt reports receiving consultant/honoraria fees from Abbott Vascular, Avinger, Biotronik, Cordis, Covidien, Jotec and Medtronic.