12-Month full cohort results from COMPARE¹, the world’s first head-to-head, prospective, multi-center, randomized controlled Trial (1:1) comparing the low dose paclitaxel RANGER™ DCB (2 µg/mm²) to the higher dose paclitaxel IN.PACT™ DCB (3.5 µg/mm²). Primary endpoints were binary primary patency and freedom from major adverse events. 

Presented at LINC 2020 by Sabine Steiner, MD and simultaneously published in European Heart Journal

COMPARE Manuscript

Definitions

Primary safety endpoint — composite of freedom from device and procedure-related death through 30-days and freedom from major target limb amputation and CD-TLR through 12 months post index-procedure.

Primary efficacy endpoint — primary patency at 12 months defined as absence of clinically-driven target lesion revascularization (CD-TLR) or binary restenosis determined as a peak systolic velocity ratio > 2.4 evaluated by duplex ultrasound core laboratory analysis.

CD-TLR — a reintervention performed for ≥ 50% diameter stenosis (confirmed by angiography) within ± 5 mm proximal and/or distal to the target lesion after documentation of recurrent clinical symptoms of PAD (increase of 1 Rutherford class or more) and/or drop of ABI (≥20% or ≥0.15 when compared to maximum early postprocedural level).