The novel DynamX novolimus-eluting stent showed positive remodeling in implanted coronary arteries through 1 year in a small, nonrandomized study, according to a late-breaking trial presented Friday at the PCR e-Course.
The trial included 50 consecutive patients with single de novo coronary artery lesions with reference vessel diameter of 2.5 to 3.5 mm and lesion length of ≤24 mm, at seven international sites. Each patient underwent percutaneous coronary intervention with the DynamX Novolimus-Eluting Coronary Bioadaptor System (Elixir Medical Corp.).
The DynamX stent is 71 microns thick with a cobalt-chromium platform. While current-generation drug-eluting stents (DES) “cage” the coronary artery, causing geometric distortion and inhibiting positive adaptive remodeling and vasomotion, the DynamX stent has a novel “uncaging” mechanism of the circumferential rings after 6 months while maintaining the axial links following uncaging, according to a press release accompanying the results.
The primary safety endpoint is target lesion failure (TLF) at 6 months. TLF is a composite endpoint defined as cardiac death, target vessel myocardial infarction (MI), and clinically indicated target lesion revascularization (TLR).
The primary imaging/efficacy endpoints for those patients undergoing imaging follow-up is the change in mean in-device area and mean lumen area at 9 or 12 months compared to post-procedure as measured by intravascular ultrasound (IVUS).
The co-primary imaging/efficacy endpoint for those patients undergoing imaging follow-up is late lumen loss as measured by QCA and IVUS at 9 or 12 months.
The results presented by Stefan Verheye, MD, PhD, of ZNA Middleheim Antwerp Cardiovascular Center, Antwerp, Belgium, show that there was no TLF through 6 months, and two patients (4%) experienced TLF (both died of cardiac causes) through 12 months. Verheye noted that there was no target vessel revascularization or TLR through 1 year.
The patients who underwent IVUS also showed positive adaptive remodeling to maintain lumen area (mean lumen area post-procedure, 7.39 ± 1.20 mm2; 9- and 12-month follow-up, 7.36 ± 1.31 mm2; change from post-procedure, 0%; p=0.594). There were changes in mean vessel area (post procedure, 14.10 ± 2.99 mm2; 9- and 12-month follow-up, 14.54 ± 3.12 mm2; change from post-procedure, 3%; p=0.017) and mean biodaptor area (7.39 ± 1.20 mm2; 9- and 12-month follow-up, 7.74 ± 1.46 mm2; change from post-procedure, 5%; p=0.0005).
The increases in vessel and device area allow the vessel to maintain the lumen diameter and preserve good blood flow over time, Verheye said.
This is important, he said, because drug-eluting stents have high major adverse cardiac event rates beyond 1 year, at a rate of 2% to 3% without plateau.
Verheye concluded that the DynamX Bioadaptor stent demonstrated excellent safety through 12-month follow-up and excellent efficacy. He added that the stent’s innovative design allows the bioadaptor to match current DES in acute performance while showing promise of lowering the annualized event rates beyond the first year post-implantation.
PCR e-Course is the virtual meeting being held in place of the annual in-person EuroPCR congress, which was canceled because of the COVID-19 pandemic.
The study is sponsored by Elixir Medical Corp.