MOTIV Bioresorbable Scaffold in Below-The-Knee Artery Disease: European Post-Market Pilot BTK Trial: 36-Month Results.

Purpose THE primary objective of the MOTIV BTK PILOT STUDY WAs to evaluate the immediate and long-term safety and efficacy of the MOTIV® sirolimus-eluting bioresorbable scaffold (Reva Medical, San Diego, California, USA) in below-the-knee (BTK) arteries for the treatment of patients with rest pain or minor tissue loss (critical limb-threatening ischemia (CLTI)).Materials And Methods This is a prospective, single-arm, multi-center trial of a novel drug-eluting bioresorbable scaffold with a new scaffold material (Tyrocore®), which includes an iodinated, polycarbonate copolymer of tyrosine analogs and has a surface coating of the same Tyrocore material and the antiproliferative drug sirolimus. Fifty-eight patients were included between August 2019 and July 2021. The primary efficacy outcome measure was primary patency at 12 months. The primary safety outcome measure was freedom from serious device-related adverse events at 30 days. Secondary outcome measures were immediate technical success, primary patency at 24 and 36 months, clinically driven target lesion revascularization rate (CD-TLR) and limb salvage at 12, 24, and 36 months. Follow-up was performed at 1, 6, 24, and 36 months, including clinical assessment and core laboratory adjudicated color duplex ultrasound.Results Seventy-six MOTIV scaffolds were implanted in 60 study limbs with an average lesion length of 29.5 mm. Primary patency at 12, 24, and 36 months was 88.3%, 81.7%, and 80% (with numbers of limbs at risk being 43, 38 & 30) respectively. The 30-day adverse event rate was 1.7%. Technical success was achieved in 99%. At 3 years, freedom from CD-TLR was 93% and limb salvage rate was 95%.Conclusion The 36-month results of this pilot MOTIV BTK study demonstrated favorable safety and effectiveness performance in CLTI patients with BTK atherosclerotic disease.Level Of Evidence Level 3: non-randomized controlled cohort study.