Coronary interventions

Twelve-month clinical and imaging outcomes of the uncaging coronary DynamX bioadaptor system

EuroIntervention 2020;16:e974-e981. DOI: 10.4244/EIJ-D-20-00763

Stefan Verheye
Stefan Verheye1, MD, PhD; Mathias Vrolix2, MD; Matteo Montorfano3, MD; Carlo Zivelonghi1, MD; Francesco Giannini4, MD; Francesco Bedogni5, MD; Christophe Dubois6, MD, PhD; Bernard De Bruyne7, MD, PhD; Ricardo A. Costa8, MD; Daniel Chamié8, MD; José de Ribamar Costa Jr8, MD; Dean J. Kereiakes9, MD; Alexandre A. Abizaid8, MD; Antonio Colombo4, MD
1. Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium; 2. Department of Cardiology, Ziekenhuis Oost-Limburg, Genk, Belgium; 3. San Raffaele Scientific Institute, Milan, Italy; 4. Interventional Cardiology Unit, GVM Care & Research, Maria Cecilia Hospital, Cotignola (RA), Italy; 5. Department of Cardiology, IRCCS Policlinico San Donato, San Donato Milanese-Milan, Italy; 6. Department of Cardiovascular Medicine, Universitaire Ziekenhuizen Leuven, Leuven, Belgium; 7. Cardiovascular Center Aalst, Aalst, Belgium; 8. Cardiovascular Research Center, São Paulo, Brazil; 9. The Christ Hospital, Heart and Vascular Center/The Lindner Research Center, Cincinnati, OH, USA

Aims: We aimed to assess the safety and efficacy of the DynamX Novolimus-Eluting Coronary Bioadaptor System, a novel device that initially acts as a second-generation drug-eluting stent, but after six months frees the vessel through uncaging elements.

Methods and results: This multicentre study enrolled 50 patients with single de novo lesions. In-device acute lumen gain was 1.61±0.34 mm, and device and procedure success was 100%. Up to 12 months, two target lesion failures occurred: both were cardiac deaths (day 255 and day 267 post procedure). No definite or probable device thrombosis was observed. Mean late lumen loss was 0.12±0.18 mm in-device and 0.11±0.16 mm in-segment. Per intravascular ultrasound, the mean device area and mean vessel area increased significantly by 5% and 3%, respectively, while the mean lumen area was maintained. Stationary optical coherence tomography in seven patients demonstrated restoration of cyclic pulsatility, with an approximate lumen area variance of 11% between systole and diastole.

Conclusions: The DynamX bioadaptor showed drug-eluting stent-like acute performance and safety and efficacy up to one year. Positive remodelling with an increase of vessel and device area while maintaining the mean lumen area was demonstrated. Long-term follow-up and randomised trials are required to assess the benefit of this device on events beyond one year.

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clinical researchstable anginamiscellaneousother technique
Coronary interventionsStents and scaffoldsOther coronary interventions
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