Stents (Bare-metal, Drug-eluting)
A Non-Randomized, Clinical Registry of the DynamX Novolimus Eluting Coronary Bioadaptor System in the Treatment of Patients With De Novo Native Coronary Artery Lesions - “DynamX Hong Kong Registry”
Bryan Ping-Yen Yan1, Li Wah Tam2, Sunny C F Tsang3, Wai Kin Chi4, Frankie CC Tam5, Michael Kang-Yin Lee3
The Chinese University of Hong Kong, Hong Kong, China1, Kwong Wah Hospital, Hong Kong, China2, Queen Elizabeth Hospital, Hong Kong, China3, Prince of Wales Hospital, Hong Kong, China4, Queen Mary Hospital, Hong Kong, China5
Drug-eluting stents (DES) have reduced 1-year major adverse event rates, but a non-plateauing increase of 2-3 % continues. The DynamX™ Novolimus-Eluting Coronary Bioadaptor System is a 71 µm cobalt-chromium platform with a novel “uncaging” mechanism (≥ 6 months) of the circumferential rings while maintaining the axial links between rings. DynamX combines acute performance of contemporary DES with benefits of “uncaging” allowing positive adaptive remodeling, and restoration of vessel function, compliance and geometry.
This first Asia-Pacific study enrolled 50 patients with de-novo lesions at 3 Hong Kong centers between November 2020 and October 2021. DynamX was available in diameters of 2.25 - 3.5 mm, lengths of 14 - 38 mm. Key exclusion criteria were left main, bypass grafts, in-stent restenosis, chronic total occlusion and bifurcation lesions. Endpoints included acute device and procedure success, composite endpoint of cardiac death, target-vessel myocardial infarction (MI), clinically-indicated target lesion revascularization (TLR); and device thrombosis. Clinical follow-up occurred at 1, 6 and 12 months. Dual anti-platelet therapy was given according to current guidelines for DES.
Fifty patients (mean age 64.0 ± 9.7 years, 82 % male) received 60 DynamX Bioadaptor in 57 lesions (19 % B2 or C lesions). Diabetes was diagnosed in 36 %, hypertension in 76 %, hypercholesterolemia in 92 % and 30 % were current smokers. Acute device success was achieved in 98 % (n=49/50) cases. There was one failure to cross requiring atherectomy and subsequent overlapping DES and 3 cases of edge dissection treated with additional DynamX without complications. Procedure success was 100 %. 30-days follow-up was complete (n=50/50) with no incidence of death, MI, TLR or thrombosis. A full summary of demographics, lesion characteristics and clinical results through 6 months will be presented.
In this study, DynamX Bioadaptor offered excellent acute performance similar to contemporary DES. Long-term benefits of uncaging will be assessed by follow-up angiography with optical coherence tomography imaging and longer-term clinical follow-up.