Am J Cardiol. 2026 Feb 27:S0002-9149(26)00101-3. doi: 10.1016/j.amjcard.2026.02.051. Online ahead of print.
ABSTRACT
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 non-complex coronary lesions. Our aim was to investigate the performance of 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 post-procedure 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) 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. Post-procedural 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, four patients (7.4%) experienced major adverse cardiac events, including one target vessel myocardial infarction and four 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.
PMID:41765253 | DOI:10.1016/j.amjcard.2026.02.051