The GORE-EPI study, conducted by RCTs using the French healthcare database system (Système National des Données de Santé (SNDS)), evaluated the real-life long-term morbidity and mortality of patients implanted with the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE). The main outcome was a composite endpoint including events such as mortality, aortic endovascular reintervention (AER), embolizations for endoleak, branch thrombectomy, or bypass surgeries. The results showed that at one and two years after implantation, respectively 84% and 79% of patients were free from any morbidity or mortality event.
This study demonstrates the value of SNDS in long-term evaluation using clinical endpoints of almost all patients implanted in France with the studied medical device, with no patients lost to follow-up.
N° T28825232020111 (https://www.health-data-hub.fr/projets/etude-post-inscription-de-gorer-excluderr-iliac-branch-endoprosthesis-ibe-lanalyse-des)
Data Controller: W.L. GORE
Data Processor: RCTs
Scientific Committee: Antoine Million, Elixène Jean-Baptiste, Fanny Raguideau
https://www.valueinhealthjournal.com/article/S1098-3015(23)05377-9/abstract