The first results have been announced from ENCORE, a pooled, global analysis of several prospective clinical trials and registries studying polymer endovascular aneurysm repair (Polymer EVAR) using Ovation Abdominal Stent Graft Systems (Endologix).
ENCORE is a pooled, retrospective analysis of six prospectively enrolled clinical trials and registries of Ovation Abdominal Stent Graft Systems encompassing 1,296 patients, 160 centres and 339 investigators in the USA, Europe and Latin America. This contemporary analysis standardises outcome variables across each study. The data is a mix of real world registry and controlled data, and all endpoints are presented using Kaplan-Meier survival estimates.
Median follow up across all studies was 883 days (range 30 days–5 years). At five years, the ENCORE analysis included the following results for Ovation based on the available data:
- 1% freedom from AAA-related mortality
- 0% freedom from reintervention for Type Ia endoleak
- 7% freedom from rupture
- 2% freedom from conversion
- 4% freedom from all device-related reintervention
“With ENCORE, our objective was to conduct a rigorous, global evaluation of the available Polymer EVAR clinical data, which includes nearly 1,300 patients, and to share the consolidated results with physicians worldwide,” says Matt Thompson, chief medical officer for Endologix. “We look forward to sharing additional analyses from the ENCORE data set in the future, and we’d like to thank all of the clinical investigators who participated in the underlying studies that are the basis for the ENCORE analysis.”