Clinical and imaging results at 12 months for the DynamX Novolimus-Eluting Coronary Bioadaptor system (Elixir Medical) have demonstrated “excellent” safety and efficacy, a late-breaking trial session at the PCR e-Course 2020 event (25–27 June) has been told.
Stefan Verheye (Antwerp Cardiovascular Center ZNA Middelheim, Antwerp, Belgium) outlined the data on the DynamX Bioadaptor. He said: “Drug-eluting stent event rates beyond year one remain high, accumulating at a rate of 2–3% per year without plateau. The DynamX Bioadaptor performs similar to a second generation drug-eluting stent—with implantation technique, deliverability, conformability, and radial strength during the healing phase, and later a novel “uncaging” of the vessel. The bioadaptor is the first metallic coronary artery implant to demonstrate positive adaptive remodelling of the vessel, enabling it to expand to accommodate disease progression.”
The DynamX Novolimus-Eluting Coronary Bioadaptor system is a 71micron thin, cobalt-chromium platform with a novel “uncaging” mechanism of the circumferential rings after six months while maintaining axial links following uncaging.
The purpose of the non-randomised study was to evaluate the safety and performance of the DynamX in de novo native coronary arteries, in 50 consecutively enrolled patients. Principal clinical endpoints were target lesion failure (cardiac death, target vessel myocardial infarction, and clinically-indicated target lesion revascularisation, and bioadaptor thrombosis at 9/12 months. Clinical follow-up will continue annually through three years. Multimodality imaging endpoint analyses using quantitative coronary arteriography (QCA) for late lumen loss and intravascular ultrasound (IVUS) for change in mean and minimum lumen, bioadaptor, and vessel areas from post-procedure to nine and 12-month follow-up were performed at baseline and at nine or 12 months in subgroups. Optical coherence tomography (OCT) imaging was performed in a subset of patients at the nine or 12 month timepoint.
There were no cases of target vessel revascularisation at 12 months, or of definite or probable thrombosis, with two cases of target lesion failure at nine (n=49) and 12 (n=48) months. There were two deaths due to cardiac causes at nine months.
Investigators observed an acute lumen gain of 1.63±0.34mm, with low late lumen loss (0.12±0.18mm) by QCA. They say the IVUS imaging showed the unique feature conferred by vessel uncaging that allowed for the vessel to undergo positive adaptive remodelling to maintain lumen area for good blood flow over time, a characteristic not observed with metallic stents. Clinical data showed no target vessel revascularisation or definite/probable device thrombosis through 12 months.
Verheye said at the PCR e-Course: “The DynamX Bioadaptor demonstrated excellent safety through 12-month follow-up, and excellent efficacy as demonstrated by preserved positive adaptive remodelling, and maintained the vessel lumen as demonstrated by IVUS data and low late lumen loss by QCA at 9/12 months.”
He described it as “a fundamental innovation in device design that allows the bioadaptor to match current drug-eluting stents in acute performance while showing the promise of mitigating the 2–3% annualised event rates beyond year one. Longer-term follow-up in comparative studies will study the potential for reduction in these device-oriented events that have been observed with current drug-eluting stents.”