One-Year Results for Long Lesions Treated with Ranger DCB

Purpose: Data from patients with lesions 100 mm or longer from the Ranger DCB (Boston Scientific, Marlborough, MA) arm of the RANGER II SFA randomized trial and the Long Balloon substudy (Ranger DCB lengths 120–200 mm) were pooled for analysis of 1-year safety and efficacy.

Materials and Methods: Randomized controlled trial and substudy eligibility criteria were identical (i.e., stenotic lesions ≤180 mm) except for allowance of longer occluded lesions in the Long Balloon Substudy (≤150 mm vs 100 mm). Core laboratory- adjudicated primary patency (duplex ultrasound PSVR ≤2.4 in the absence of clinically driven TLR [CD-TLR]) and MAE (i.e., TLR, major amputations, death within 1 month) were assessed at 12 months.

Results: Data from 129 patients with lesions at least 100 mm were pooled for the analysis. Mean lesion length was 144.5 ± 31.7 mm, PACSS calcification 3/4 present in 58.1% (75/ of 129), and 32.6% (42/129) had occlusions. Twelve-month primary patency was 80.5% (91 of 113). MAE-free rate was 95.1% (117 of 123); all MAE were CD-TLR.

Conclusions: Results from a cohort of patients with long lesions treated with Ranger DCB show high patency and low reintervention rates through 1 year