Article Text
Abstract
Introduction REVISAR is a prospective multicenter study on mechanical thrombectomy in distal vessels using the APERIO® (Hybrid (17)) Stentretriever.
Aim of Study To evaluate the safety and efficacy of the APERIO® (Hybrid(17)) Thrombectomy device in distal artery occlusions in the anterior and posterior circulation.
Methods Data was collected prospectively from all patients who signed informed consent. Efficacy endpoints were successful recanalization (TICI 2b-3) within 3 passes, no rescue therapy, no sICH and a good outcome at 90 days (mRS≤2). Primary safety endpoints were device- and procedure-related (serious) adverse events (AEs/SAEs) and mortality. Imaging data were evaluated by the centers and a central core lab. Primary inclusion criterion was treatment with the APERIO, the APERIO® Hybrid or APERIO® Hybrid17. Major exclusion criteria were any contraindication according to IFU and pretreatment mRS of ≥3.
Results 134 patients were enrolled between 2020 and 2023. Median age was 74, 51% of the patients were female, median NIHSS was 7. There were 83 M2 (62%), 19 M3 (14%), 13 P1/2 (10%), 7 A1-3 (5%) and 12 other occlusions (9%). Successful recanalization (mTICI 2b-3) was achieved in 95.5%. A favourable mRS at day 90 (0-2) was found in 91/119 patients available for FU (76%). ICH occured in 23 patients (19 with and 4 with symptoms). 8 patients had a worse clinical outcome at discharge than prior to the infarction. 6 (4.5%) patients died.
Conclusion The final analysis shows a good safety profile and a high efficacy of APERIO® Stentretriever in distal occlusions.
Disclosure of Interest yes this work was sponsored by Acandis.