DynamX Bioadaptor, a novel "uncaging" platform for coronary artery revascularization: final 36-month clinical results

ABSTRACT

BACKGROUND Compared with bare-metal stents, drug-eluting stents (DES) reduce major adverse cardiac events (MACE) in the first year after percutaneous coronary intervention (PCI) but still have an ongoing 2% to 3% annual event rate reaching 20% at 5 years and 40% to 50% at 10 years. The DynamX Novolimus-Eluting Coronary Bio adaptor System is a 71-mm, cobalt-chromium platform with a novel "uncaging" mechanism of circumferential rings that maintains the axial links between the rings following uncaging. Conventional metallic DES "cage" the coronary artery, inhibiting positive adaptive remodeling and vasomotion and causing geometric distortion. These factors likely contribute to the persistent annual MACE rate after PCI. The DynamX Bioadaptor combines the acute performance of contemporary DES and unique benefits of arterial "uncaging" beyond 6 months, allowing positive adaptive remodeling, restoring compli ance, and allowing treated vessels to return toward native vessel geometry. METHODS In this study the DynamX Bioadaptor was available in di ameters of 2.5 to 3.5 mm and lengths of 14 to 28 mm. This mechanistic clinical study enrolled 50 patients (mean age 66.3 8.8 years) at 5 centers in Belgium and Italy. Multiple endpoints including target lesion failure were assessed, with clinical follow-up through 3 years. Multimodality imaging endpoint analyses using quantitative coronary angiography, intravascular ultrasound, and optical coherence to mography were performed at baseline and at 9 or 12 months in separate subgroups. RESULTS Mean area changes for Bioadaptor, reference vessel and lumen as well as percentage neointimal volume and neointimal thickness observed at 9 and 12 months demonstrate Bioadaptor per formance and ability to preserve positive adaptive remodeling. Through 24 months, target lesion failure events were observed in 4.3% of patients, which is in line with contemporary DES clinical outcomes. Detailed imaging and final clinical data through 36 months will be presented. CONCLUSION The DynamX Bioadaptor demonstrated performance attributes of contemporary metallic DES with the unique capacity to restore positive adaptive remodeling through vessel "uncaging." Final clinical data through 36 months demonstrate longer term safety and efficacy.