The Official Journal of EuroPCR and the European Association of Percutaneous Coronary Interventions (EAPCI)
Twelve-month clinical and imaging outcomes of the uncaging DynamX Bioadaptor System
Stefan Verheye1; Mathias Vrolix2; Matteo Montorfano3; Carlo Zivelonghi1; Francesco Giannini4; Francesco Bedogni5; Christophe Dubois6; Bernard De Bruyne7; Ricardo A Costa8; Daniel Chamié8; José Ribamar Costa Jr8; Dean J Kereiakes9; Alexandre Abizaid8; Antonio Colombo4;
1. Interventional Cardiology, ZNA Cardiovascular Center Middelheim, Antwerp, Belgium, 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
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Aims-We assessed 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 multi-center 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%. Through 12 months, two target lesion failures occurred, both were cardiac deaths (day 255 and 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 through 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 randomized trials are required to assess the benefit of this device on events beyond one year.