DYNAMX Bioadaptor Implantation for Treatment of Complex Coronary Artery Disease: The DYNAMITE Study.

Percutaneous coronary intervention (PCI) with drug-eluting stent implantation still presents limitations related to permanent vessel caging. Implantation of a novel bioadaptor demonstrated promising outcomes in de novo noncomplex coronary lesions. Our aim was to investigate the performance of the DynamX (Elixir Medical Corporation, Milpitas, CA) sirolimus-eluting bioadaptor in complex coronary lesions. DYNAMITE (DYNAMX stent ImplanTation for the trEatment of complex coronary lesions) is an observational, prospective, single-arm, single-center cohort study that enrolled patients with de novo complex coronary lesions undergoing PCI with DynamX between September 2021 and August 2023. The primary co-endpoints were the difference in mean device area and mean in-device lumen area from postprocedure to 9 months as measured by optical coherence tomography. A total of 55 patients (55 lesions) were enrolled. Mean age was 67 ± 10 years, 7% (n = 4) were female, and 29% (n = 16) were diabetic. Lesions had moderate/severe calcification in 64% (n = 35), were chronic total occlusions in 22% (n = 12), and bifurcations in 16% (n = 9) of cases. Postprocedural mean device area was 8.15 ± 0.64 mm2, and in-device lumen area 8.27±1.78 mm2. At 9-month follow-up, mean device area increased to 8.53 ± 1.71 mm2 (absolute difference: 0.37 ± 0.99 mm²; relative difference: 5.52 ± 14.8%, p = 0.010), and mean in-device lumen area decreased to 7.57 ± 1.86 mm2 (absolute difference: -0.70 ± 1.09 mm²; relative difference: -7.98 ± 14.9%, p <0.001). At 24-month follow-up, 4 patients (7.4%) experienced major adverse cardiac events, including one target vessel myocardial infarction and 4 target lesion revascularization events. In conclusion, DYNAMITE supports the presence of significant positive vessel remodeling in patients with de novo complex coronary lesions after DynamX sirolimus-eluting bioadaptor implantation, and suggests promising device performance at 24-month follow-up.