XLIMUS® DES: XLIMIT Trial results published on Frontiers in Cardiovascular Medicine journal
Cardionovum® announces that the XLIMIT Trial results, featuring the XLIMUS® DES, have been published online in the Frontiers in Cardiovascular Medicine journal with the article entitled “A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial”.
XLIMIT is a non-inferiority, prospective, multicenter, randomized, controlled trial in which a total of 177 patients were enrolled and randomized in two groups in a 2:1 ratio (2 XLIMUS®:1 Synergy™).
The primary endpoint of this study has been defined as the in-stent neointimal volume weighted by the sum of the lengths of implanted stent (ISNV), and the in-stent percent neointimal volume obstruction (%VO) were evaluated at 6-9 months by means of Optical Coherence Tomography (OCT).
No significant differences were found in terms of neointimal volume between the 2 groups (30.7 mm3 and 26.5 mm3 p=0.35 for XLIMUS® vs Synergy™, respectively), thus meeting the non-inferiority hypothesis.
Moreover, no difference was found with respect to secondary OCT endpoints as well as for clinical endpoints.
The XLIMIT trial shows that the innovative design of the XLIMUS® DES ensures an equivalent performance in terms of OCT derived endpoints than the Synergy™ DES and confirms that the biological interaction of the XLIMUS® DES and Synergy™ DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters ad clinical results at follow-up: as such, XLIMUS® is non inferior to Synergy™.