Dynetic-35 cobalt chromium balloon-expandable stent for iliac lesions: 12-month results of the BIONETIC-I Multi-Center study

Purpose: The BIONETIC-I trial aimed to evaluate the safety and effectiveness of the Cobalt chromium Dynetic-35 stent, used in conjunction with the Passeo-35 Xeo peripheral dilation catheter, for treating atherosclerotic lesions in iliac arteries of patients with peripheral artery disease (PAD). Materials and Methods: This international, multi-center, prospective, single-arm study enrolled 160 subjects with 212 lesions across six European countries. The primary endpoint was a composite of major adverse events (MAE) at 12 months, including device or procedure-related death within 30 days, clinically-driven target lesion revascularization (cdTLR), and major index limb amputation. Secondary endpoints included technical and procedural success, cdTLR rate, mortality, major amputation rate, primary patency, and changes in PAD-related parameters. Results: The patients (61.9% male, median age 65 years) presented with predominantly calcified lesions (90.1%) and high-grade stenosis (average 85.5%), with 12.5% having CLTI. The 12-month MAE rate was 3.5% (97.5% Upper Confidence Limit: 7.2%), significantly non-inferior to the pre-specified performance goal (p<0.0001). Secondary endpoints showed favorable 12-month outcomes, including a low cdTLR rate (2.0%), robust corelab-reported primary patency (93%), and significant improvements in PAD-related parameters such as Ankle-Brachial Index, Rutherford classification and Walking Impairment Questionnaire. Subgroup analysis revealed no differences in MAEs between patients with severe/moderate and mild/no calcification, with notable improvements in functional measures for those with severe/moderate calcification. Conclusion: The Balloon-Expandable Cobalt chromium stent Dynetic-35 demonstrated safety and effectiveness in treating iliac arteries at the 12-month timepoint, showing promising results across various patient subgroups, including those with calcified lesions. Level of evidence: Level 2, therapeutic study. Trial registration: ClinicalTrials.gov, NCT04830228. Registered 31 March 2021, https://clinicaltrials.gov/ct2/show/NCT04830228