Cardionovum’s Xlimus DES Evaluated in OCT-Derived Endpoints in XLIMIT Trial

November 22, 2022—Germany-based Cardionovum GmbH recently announced data from the XLIMIT randomized controlled trial demonstrating an equivalent performance of the company’s Xlimus drug-eluting stent (DES) in terms of optical coherence tomography (OCT)–derived endpoints compared to the Synergy DES (Boston Scientific Corporation), 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 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 trial, stated the company.

Cardionovum’s Xlimus sirolimus-eluting coronary stent system merges the features of a bioresorbable polymer DES with last-generation engineering applied to the platform construction.

The findings were presented in the Innovation session at the CSC 2022 Congress, the Coronary & Structural Course held November 16-18 in Madrid, Spain.

Luca Testa, MD, is lead Principal Investigator of the XLIMIT trial.

“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,” commented Dr. Testa in Cardionovum’s press release. “The XLIMIT trial showed the reassuring safety and efficacy profile of the Xlimus DES, thus paving the way for future developments of this technology.”

As summarized in the company’s press release, the prospective, multicenter XLIMIT randomized controlled trial was composed of 177 patients (male, 77.4%; mean age, 64 years; diabetes, 21.5%) enrolled from February 2019 and March 2022 at four sites. Of these patients, 47.1% were admitted to the hospital with stable angina/silent ischemia and 42% were admitted for acute coronary syndrome. Patients in the study were randomized to two groups in a 2:1 ratio of Xlimus to Synergy.

The primary endpoint, which was defined as in-stent neointimal volume at 6-month follow-up with OCT, was evaluated in 118 patients. The secondary endpoints analysis included 167 patients.

The investigators analyzed neointimal volume for a total of 137 lesions (Xlimus, 89 vs Synergy, 48) and found no significant difference between the two groups (30.7 mm³ vs 25.5 mm³; P = .35). The neointimal volume weighted by length showed no significant difference (1.1 mm³ vs 0.9 mm³; P = NS). The in-stent minimal lumen area at 6-month follow-up was 4.3 mm² versus 4.7 mm² (P = .25). Strut coverage was > 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, noted the company.