AUTHOR=Testa Luca , Squillace Mattia , Ventrella Nicoletta , Moreno Raul , Jiménez-Valero Santiago , Serra Antoni , Gomez Hospital Joan Antoni , Bellamoli Michele , Popolo Rubbio Antonio , Bedogni Francesco 

TITLE=A randomized control trial to assess optical coherence tomography parameters of the Xlimus drug-eluting stent: the XLIMIT trial

JOURNAL=Frontiers in Cardiovascular Medicine

VOLUME=10

YEAR=2023

URL=https://www.frontiersin.org/journals/cardiovascular-medicine/articles/10.3389/fcvm.2023.1199475

DOI=10.3389/fcvm.2023.1199475

ISSN=2297-055X

ABSTRACT=<sec><title>Background</title><p>Third generation drug-eluting stents (DES) potentially offer better technical performance and reduced neointimal proliferation than previous generation DES. The XLIMIT non-inferiority trial evaluated the performance of the Xlimus (a novel sirolimus-eluting coronary stent system) in terms of endothelialization and tissue healing compared to the bioresorbable polymer Synergy DES.</p></sec><sec><title>Methods</title><p>A total of 177 patients undergoing percutaneous coronary intervention (PCI) were randomized in a 2:1 ratio (2 Xlimus: 1 Synergy). The primary endpoints, defined as the in-stent neointimal volume weighted by the sum of the lengths of the implanted stent (ISNV) and the in-stent neointimal percent volume obstruction (%VO) were evaluated at 6–9 months by means of optical coherence tomography (OCT). Additional OCT parameters as well as clinical endpoints were also collected.</p></sec><sec><title>Results</title><p>Most of the patients were males (77.4%), and the mean age was 64 years. One third of the population had stable angina/silent ischemia. A total of 300 stents (237 lesions) were analyzed: 198 (152 lesions) were in the Xlimus group, and 102 (85 lesions) in the Synergy group. The ISNV in the Xlimus group was 30.7 ± 24.5 mm<sup>3</sup> while in the Synergy group it was 26.5 ± 26.7 mm<sup>3</sup>: the difference between the two means was 0.08 (−0, 04–0, 45), <italic>p</italic> = 0.018, thus meeting the non-inferiority hypothesis. The %VO was 16.3% ± 10.4% and 13.3% ± 10.8% in the Xlimus and Synergy groups, respectively: the difference between the two means was 3.0 (−0, 06–4, 2), (<italic>p</italic> = 0.01), thus meeting the non-inferiority hypothesis. No difference was found with respect to the secondary OCT endpoints as well as for clinical endpoints.</p></sec><sec><title>Conclusions</title><p>The study results confirm that the biological interaction of the Xlimus and Synergy DES with the coronary artery is comparable, and that translates in very reassuring OCT parameters at follow-up: as such, the Xlimus is non-inferior to the Synergy.</p></sec><sec><title>Clinical Trial Registration</title><p><ext-link ext-link-type="uri" xlink:href="https://www.ClinicalTrials.gov" xmlns:xlink="http://www.w3.org/1999/xlink">ClinicalTrials.gov</ext-link>, identifier (NCT03745053).</p></sec>