Results from the EXCELLA II randomised trial presented at TCT 2012 have shown lower re-intervention rates with the DESyne Novolimus Eluting Coronary Stent System compared with the Endeavor zotarolimus-eluting system.
At three years, device-oriented composite endpoints, a measure of major adverse events, for Elixir’s DESyne (Elixir Medical) were low and essentially unchanged through one, two and three years (4.3%, 4.3% and 5.0%) while the control Endeavor (Medtronic) increased yearly (7%, 9.9% and 12.7%) with a trend towards statistical significance (p=0.057). Target lesion revascularisation rates at three years were significantly lower in favour of the DESyne stent as compared to the control (1.4% vs. 9.9%; p=0.008).
“The excellent and sustained clinical outcomes over three years clearly distinguish DESyne from other commercially available drug-eluting stents, which typically exhibit deterioration of clinical outcomes over time,” said Joachim Schofer, Universitares Herz- und GefaBzentrum, Hamburg, Germany. “DESyne is a strong next generation product for physicians seeking to further improve patient outcomes.”
The DESyne stent elutes the novel compound novolimus. It is the first drug eluting stent to successfully combine the thinnest durable polymer coating, the lowest drug dose, and thin stent struts to achieve excellent clinical outcomes as compared to other commercially available drug eluting stent systems. The EXCELLA II trial had previously demonstrated both non-inferiority and superiority of DESyne compared to Endeavor for the primary endpoint of in-stent late lumen loss at nine months.
The EXCELLA II trial is a multicentre, randomized, single blind, evaluation of the DESyne stent compared to the control Endeavor system. The study was designed to enrol 210 patients from Europe, Australia, New Zealand and Brazil. The primary endpoint was in-stent late lumen loss assessed by quantitative coronary angiography (QCA) at nine months. Secondary endpoints of the study include: device-orientated composite endpoints and stent thrombosis rates at 30 days; six, nine, 12 months, and yearly thereafter through five years. A subset of patients underwent intravascular ultrasound (IVUS) evaluation at nine months.
At nine months, the Elixir DESyne Stent demonstrated non-inferiority and superiority (p<0.001) to the Endeavor stent for the primary endpoint of in-stent late lumen loss (0.11±0.32 and 0.63±0.42 respectively). In a subset of patients who underwent IVUS, the DESyne stent demonstrated a statistically significant reduction in neointimal inhibition with a percentage volume obstruction of 4.5%±5.1 compared to 20.9%±11.3 for the Endeavor Stent (p <0.001). Clinical events measured using the device oriented composite endpoint were lower for the DESyne stent compared to the Endeavor stent (2.9% and 5.6% respectively).
DESolve Nx pivotal trial
Elixir Medical has announced enrolment completion of the 120-patient, pivotal clinical trial evaluating the safety and efficacy of the DESolve Novolimus Eluting Bioresorbable Coronary Scaffold System. The scaffold is designed to resorb in the body within one to two years after implantation and return the patients’ coronary vessel to de novo state. Patient follow-ups are expected to be completed by yearend.
The primary safety endpoint of the DESolve Nx trial is the composite of major adverse cardiac events (MACE) comprised of cardiac death, target vessel myocardial infarction and clinically-indicated target vessel revascularisation. The primary angiographic endpoint of the trial is in-stent late lumen loss at six months as assessed by quantitative coronary angiography. In a sub-set of patients, additional quantitative coronary angiography assessment will be conducted at 24 months; stent and vessel assessment using IVUS, optical coherent tomography will be conducted at baseline, six and 24 months; and multislice computed tomography at 12 months thus providing long-term assessment of the scaffold and surrounding vessel.
“Bioresorbable drug-eluting scaffolds that effectively treat the coronary artery obstruction without leaving a permanent metallic implant behind in the long term are undoubtedly the next frontier for interventional cardiology,” said Stefan Verheye, ZNA Middleheim Hospital, Antwerp, Belgium, and principal investigator of the DESolve Nx Study. “Having used the DESolve bioresorbable scaffold system in two clinical studies, and observed its impressive performance, I am confident that Elixir’s DESolve scaffold system can achieve and maintain excellent long-term clinical outcomes.”
The DESolve scaffold made from a proprietary and proven poly-L Lactide (PLLA)-based polymer provides optimal strength and support to the artery while delivering the novel anti-proliferative drug, Novolimus. Some unique features of the DESolve scaffold design as demonstrated in preclinical testing include (a) the ability to self-appose to the vessel wall in cases of malapposition; (b) the ability to maintain radial strength and vessel support for the critical period of vessel healing while bioresorbing within 12–24 months; and (c) a wide margin of scaffold expansion without strut fracture.
The multicentre, prospective DESolve Nx Trial was designed to enrolled 120 patients at 15 centers in Germany, Belgium, Poland, Brazil and New Zealand. Enrolment completion of this DESolve Nx trial follows outstanding results of Elixir’s DESolve First-In-Man Study wherein at six months, Elixir’s DESolve demonstrated excellent late lumen loss of 0.19±0.19mm, no artery blockage (0.0% binary restenosis), no late malapposition (0.0%), low acute recoil (6.4% ± 4.3), no cases of blood clots (0.0% stent thrombosis), and a single MACE event due to a stenosis in the segment 5mm proximal to the scaffold, which itself was widely patent.
DESolve I First-In-Man Study
Elixir also announced one-year multislice coherence tomography results at TCT for the 15-patient first-in-man clinical study of the fully bioresorbable drug-eluting scaffold, the DESolve Bioresorbable Coronary Scaffold System, which were presented by Verheye.
At one year, coronary vessels treated with DESolve maintained their mean minimum lumen diameter at 2.4±0.4mm, with a per cent diameter stenosis of 15.9±10% as measured by multislice coherence tomography.