Data Presented for Elixir Medical's DESyne and DESyne BD Coronary Stent Systems

May 23, 2014—Elixir Medical Corporation announced that positive long-term results of for the company’s CE Mark–approved DESyne and DESyne BD novolimus-eluting coronary stent systems were presented at the EuroPCR 2014 congress in Paris, France. Furthermore, 18-month quantitative coronary angiography follow-up data from a subset of the company’s DESolve Nx study were presented at EuroPCR.

According to Elixir Medical, at the 5-year follow-up mark, the incidence of device-oriented composite events (DOCE) was significantly lower for the DESyne system compared to the control device (the Endeavor zotarolimus-eluting coronary stent system, Medtronic, Inc.) in the EXCELLA II randomized clinical trial, suggesting superior efficacy and safety with the Elixir system. DOCE for Elixir’s DESyne at 1, 2, 3, and 5 years (4.3%, 4.3%, 5%, and 7.9%, respectively) compared favorably to the control (7%, 9.9%, 12.7%, and 19.7%, respectively) demonstrating statistical superiority (P = .02). Target lesion revascularization rates at 5 years were also lower with the DESyne stent compared to the control (2.2% vs 8.5%; P = .06). 

The EXCELLA II trial had previously demonstrated both the noninferiority and superiority of DESyne compared to Endeavor for the primary endpoint of in-stent late lumen loss at 9 months. The 5-year follow-up of patients in EXCELLA II marks the completion of the randomized controlled trial. Elixir’s DESyne novolimus-eluting coronary stent system is commercially available in Europe, the Middle East, and Asia, the company advised.

“The significant superiority in long-term clinical outcomes over 5 years clearly distinguish Elixir’s DESyne system from other commercially available drug-eluting stents, which typically exhibit deterioration of clinical outcomes over time,” commented EXCELLA II’s Principle Investigator, Professor Patrick W. Serruys, MD, in the company’s press release. Prof. Serruys is with the Thorax Centre at Erasmus University Medical Center in Rotterdam, the Netherlands.

Three-year endpoint data were presented for the EXCELLA BD randomized clinical trial evaluating Elixir Medical’s DESyne BD novolimus-eluting coronary stent system with biodegradable polymer coating. The trial compared the DESyne BD to the control (the Endeavor zotarolimus-eluting coronary stent system with durable coating).

The company stated that the 3-year DOCE rate for the DESyne BD was exceptionally low at 5.4% compared to the control at 6.5% (P = .68). Clinically indicated target lesion revascularization rates at 3 years were also lower in favor of the DESyne BD stent compared to the control (2.7% vs 6.5%; P = .3). Moreover, there were no reported stent thrombosis events with DESyne BD through 3 years.

The biodegradable, polylactide-based material, which enables the sustained release of Elixir’s m-tor inhibitor, novolimus, to the coronary vessel wall, degrades within 6 to 9 months, leaving behind the metal stent surface and achieving excellent and sustained clinical outcomes. 

The randomized, controlled EXCELLA BD trial enrolled patients in Europe and Brazil. Previously, the trial demonstrated both noninferiority and superiority of the DESyne BD biodegradable polymer stent compared to a durable polymer 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 < .001), reported the company.

In addition to the EXCELLA II and EXCELLA BD results, the 18-month quantitative coronary angiography follow-up data in a single-center subset of 20 patients from the DESolve Nx study were also presented at EuroPCR by Coprincipal Investigator Alexandre Abizaid, MD, of Instituto Dante Pazzanese in Sao Paulo, Brazil.

The DESolve Nx results showed a minimal change in the in-scaffold late lumen loss (LLL) between 6 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, according to Elixir Medical.