Abstract 1122‐000074: EnterpriseTM 1 versus EnterpriseTM 2 Stent‐Assisted Coiling in Treating Ruptured Intracranial Aneurysms: A Real‐World Study

Introduction : Enterprise TM 2 is an innovative, self‐expandable nitinol stent system used in stent‐assisted coiling (SAC) for treating intracranial aneurysms and was formally introduced into clinical use since 2018 in China in replace of Enterprise TM 1, the first‐generation stent being used for a decade. There is a lack of evidence to compare Enterprise TM 1 with Enterprise TM 2 in the real‐world setting. The objective of this study was to investigate clinical effectiveness and safety in treating ruptured intracranial aneurysms (RIA) with Enterprise TM 2 stent (E2 group) versus Enterprise TM 1 stent (E1 group) in China. Methods : We conducted a retrospective analysis of an electronic medical record database at Yijishan hospital of Wannan Medical College. Patients included were those diagnosed with RIA and underwent SAC procedure with Enterprise TM 1 stent or Enterprise TM 2 stent from January 2013 to November 2020 with at least one follow‐up visit post discharge. Main outcomes were immediate complete occlusion (ICO) rate (Raymond‐Roy Occlusion Classification), patient functional outcomes (modified Rankin Score (mRS)), and perioperative procedural‐related complications, operating time and length of stay (LOS) and recurrence rate. Student’s t‐test was used for continuous variables and the Chi‐Square test or Fisher Exact test was used for categorical variables to test significance where appropriate. Factors associated with perioperative procedural‐related complications were explored by logistic regression. Aneurysm recurrence rate was estimated using the Life Table method. Results : A total of 361 eligible patients (E2 group = 91; E1 group = 270) were included in the analysis. There were no differences in demographic characteristics between E2 and E1 groups (mean age: 59.9 vs. 58.4 years; male gender: 27.5% vs. 29.3%). The stent deployment was successful in all patients in both groups. ICO was similar (E2 vs. E1: 79.1% vs.75.1%, P = 0.629) and most of patients achieved good function outcomes (mRS< = 2) at discharge (E2 vs. E1: 77.8% vs. 81.1%, P = 0.592). Overall, E2 group had a lower perioperative procedural‐related complication rate compared with E1 (7.7% vs.16.4%, P = 0.042). After controlling for age and underlying severity of disease (presence of hypertension, Hunt‐Hess Scale, Fisher Grade, and size and height of aneurysms), patients in E2 group had a significantly lower risk of perioperative procedural‐related complications compared with those receiving E1 (OR = 0.35; 95% CI: 0.14‐0.88). The operating time was significantly shorter (165.7± 51.6 vs.190.3±79.6 minutes, P = 0.006) in E2 vs. E1 group. While LOS was also shorter in E2 group (16.7±9.7 vs.19.2±12.6 days), the difference was not statistically significant (P = 0.082). By six‐month post discharge, patients receiving E2 had similar good functional outcomes and aneurysm recurrence compared with those in E1 group (80.2% vs. 81.9%; 13.3% vs. 14.9%, respectively). Conclusions : Compared with the Enterprise TM 1, Enterprise TM 2 had similar clinical effectiveness but with a lower perioperative procedural‐related complication risk. Use of E2 also appeared to be associated with improved clinical efficiency with shorter operating time in treating patients with RIA. The application of Enterprise TM 2 stent demonstrated encouraging clinical benefits in treating RIA in China.