Elixir Medical announces clinical results for three Novolimus eluting coronary intervention systems

Elixir Medical has announced excellent long-term results of its CE Mark-approved DESyne Novolimus eluting coronary stent system and CE Mark-approved DESyne BD Novolimus eluting coronary stent system with biodegradable polymer, both compared to the control Endeavor Zotarolimus eluting coronary system.

Outstanding 18-month results of Elixir’s CE Mark-approved DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System were also presented at the annual EuroPCR conference in Paris.

At the five-year follow-up mark, the incidence of device-oriented events was significantly lower in Elixir’s CE Mark-approved DESyne Novolimus eluting coronary stent system group compared to the control Endeavor Zotarolimus eluting coronary stent system group in the EXCELLA II randomized clinical trial suggesting superior efficacy and safety of Elixir’s system.

Device-oriented composite endpoints (DoCE), a measure of major adverse events, for Elixir’s DESyne were exceptionally low through one, two, three and five years (4.3%, 4.3%, 5.0% and 7.9%) while the control Endeavor increased yearly (7.0%, 9.9%, 12.7% and 19.7%) demonstrating statistical superiority (p=0.02). Target Lesion revascularization (TLR) rates at five years were also lower in favour of the DESyne Stent as compared to the control (2.2% vs. 8.5%; p=0.06).

Elixir’s DESyne Stent elutes the novel m-tor inhibitor 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 9 months.

The five-year follow-up of patients in EXCELLA II marks the completion of the EXCELLA II randomized controlled trial. Elixir’s DESyne Novolimus eluting coronary stent system is commercially available in countries in Europe, Middle-East and Asia.

Elixir also announced excellent long-term results of its CE Mark-approved DESyne BD Novolimus eluting coronary stent system with biodegradable polymer coating compared to the control Endeavor Zotarolimus eluting coronary stent system with durable coating in the EXCELLA BD randomized clinical trial at the three-year endpoint.

At three years, device-oriented composite endpoints (DoCE), a measure of major adverse events, for Elixir’s DESyne BD were exceptionally low at 5.4% as compared to the control at 6.5% (p=0.68). Clinically-indicated TLR rates at three years were also lower in favor of the DESyne BD stent as compared to the control (2.7% vs. 6.5%, p=0.30). Moreover, there were no reported stent thrombosis events with DESyne BD through three years.

The Elixir DESyne BD stent utilizes a proprietary technology to enable an ultrathin biodegradable polymer coating without the need for an underlying primer layer. The biodegradable, polylactide-based material, which enables the sustained release of Elixir’s novel m-tor inhibitor, Novolimus, to the coronary vessel wall, degrades within 6-9 months, leaving behind the metal stent surface achieving excellent and sustained clinical outcomes.

The randomized, controlled EXCELLA BD trial, which enrolled patients in Europe and Brazil, had already demonstrated both non-inferiority and superiority of the DESyne BD biodegradable polymer DES compared to the durable polymer DES control for the primary endpoint of in-stent late lumen loss at 6 months (0.12±0.15 mm vs. 0.67±0.47 mm respectively, p<0.001).

In addition to the above results, 18-month QCA (Quantitative Coronary Angiography) follow-up in a single center subset of 20 patients from the DESolve Nx study was also presented at EuroPCR for the first time by Alexandre Abizaid, MD, PhD, Instituto Dante Pazzanese, Sao Paulo, Brazil, and co-principal investigator.

Results showed a minimal change in the in-scaffold late lumen loss (LLL) between six and 18 months (0.25 to 0.31 mm mean LLL; median 0.13 to 0.21 mm LLL; with a mean and median change of 0.07 mm and 0.04 mm, respectively). These data confirm sustained neointimal suppression through 18 months.