一项评估Xlimus药物洗脱支架光学相干断层扫描参数的随机对照试验：XLIMIT试验。

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

作者信息

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

机构信息

Department of Cardiology, IRCCS Policlinico S. Donato, Milan, Italy.

Department of Cardiology, Hospital La Paz, IdiPAZ, Madrid, Spain.

出版信息

Front Cardiovasc Med. 2023 Sep 6;10:1199475. doi: 10.3389/fcvm.2023.1199475. eCollection 2023.

DOI:10.3389/fcvm.2023.1199475

PMID:37745092

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10511894/

Abstract

BACKGROUND

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.

METHODS

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.

RESULTS

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 while in the Synergy group it was 26.5 ± 26.7 mm: the difference between the two means was 0.08 (-0, 04-0, 45), = 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), ( = 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.

CONCLUSIONS

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.

CLINICAL TRIAL REGISTRATION

ClinicalTrials.gov, identifier (NCT03745053).

摘要

背景

与前代药物洗脱支架（DES）相比，第三代DES可能具有更好的技术性能并能减少新生内膜增殖。XLIMIT非劣效性试验评估了Xlimus（一种新型西罗莫司洗脱冠状动脉支架系统）与可生物吸收聚合物Synergy DES相比在内皮化和组织愈合方面的性能。

方法

总共177例接受经皮冠状动脉介入治疗（PCI）的患者按2:1比例随机分组（2组Xlimus: 1组Synergy）。主要终点定义为支架内新生内膜体积（通过植入支架长度总和加权，即ISNV）和支架内新生内膜体积百分比阻塞（%VO），在6 - 9个月时通过光学相干断层扫描（OCT）进行评估。还收集了其他OCT参数以及临床终点。

结果

大多数患者为男性（77.4%），平均年龄为64岁。三分之一的患者患有稳定型心绞痛/无症状性心肌缺血。总共分析了300个支架（237个病变）：Xlimus组198个（152个病变），Synergy组102个（85个病变）。Xlimus组的ISNV为30.7±24.5 mm，而Synergy组为26.5±26.7 mm：两组均值之差为0.08（-0.04 - 0.45），P = 0.018，因此符合非劣效性假设。Xlimus组和Synergy组的%VO分别为16.3%±10.4%和13.3%±10.8%：两组均值之差为3.0（-0.06 - 4.2），P = 0.01，因此符合非劣效性假设。在次要OCT终点以及临床终点方面未发现差异。