Late-Breaking Xlimit RCT data presented at CSC Congress demonstrate an equivalent performance of the Xlimus® DES in terms of OCT derived endpoints than the Synergy™ DES.

Bonn, Germany. November 16, 2022 – Data presented at Innovation session today at the CSC 2022 congress demonstrated an equivalent performance of the Xlimus® DES in terms of OCT derived endpoints than the Synergy™ DES, including Neointimal Volume and Neointimal Volume weighted by length at 6 months. Secondary endpoints, including other OCT parameters, such as in-stent Minimum Lumen Area (MLA) and percentage of strut coverage as well as clinical endpoints, showed no significant differences between the two groups in any of the evaluated parameters within the Xlimit RCT.

“The Xlimus® sirolimus eluting stent has the potential to merge the benefits of the ultra-thin struts technology and the bioresorbable polymer in a last-generation DES. The XLIMIT trial showed the reassuring safety and efficacy profile of the Xlimus DES, thus paving the way for future developments of this technology”, said Dr.Luca Testa, MD, PhD, lead principal investigator of the Xlimit trial.

Miquel Craven-Bartle Capella CEO of Cardionovum® commented: “Following our claim “Life deserves the best”, we are committed to improving patients’ quality of life by providing innovative solutions and clinical evidence for the treatment of cardiovascular disease. We truly hope that this trial will help generating a larger body of clinical evidence for a better treatment of patients with the coronary artery disease.”

Xlimit RCT Results

Xlimit is a prospective, multi-center, randomized, controlled trial. A total of 177 patients were enrolled from February 2019 and March 2022 in 4 sites, and randomized in two groups in a 2:1 ratio (2 Xlimus® : 1 Synergy™). The primary endpoint, defined as the in-stent neointimal volume evaluated at 6 month FU with OCT, was evaluated in 118 patients. Instead, 167 patients were included in the population for the secondary endpoints analysis.

Study subjects were mainly males (77.4%) and the mean age was 64 years. 47.1% of the population was admitted to the hospital with stable angina/silent ischemia and 42% for acute coronary syndrome. Diabetic patients represented the 21.5% of the study population.

The neointimal volume was analyzed for a total of 137 lesions. Of them, 89 were in the Xlimus® group and 48 in the Synergy™ one. No significant differences were found (30.7 mm³ and 25.5 mm³, respectively, p=0.35) between the two groups.  The neointimal volume weighted by length showed no significant difference between Xlimus® DES and Synergy™ DES (1.1 mm³ and 0.9 mm³ , respectively, p=NS). The in-stent minimal lumen area at 6-month FU was 4.3 mm² and 4.7 mm² for Xlimus® DES and Synergy™, respectively, p=0.25. Strut coverage was above 93% in both groups.  Other secondary endpoints, including other OCT parameters as well as clinical endpoints, showed no significant differences between the two groups in any of the evaluated parameters. No safety concern arose from the analyses.

About Xlimus® Sirolimus-eluting stent

The XLIMUS® Sirolimus Eluting Coronary Stent System (Cardionovum GmbH, Germany) is a novel promising DES technology supported by early clinical data. The XLIMUS® merges the feature of a bioresorbable polymer DES, which can reduce the inflammatory response of the arterial wall during the healing process, with last-generation engineering applied to the platform construction.