Key highlights from the PYTHAGORAS trial clinical results include:
- 218 patients were enrolled in the U.S. trial, 151 of which had high neck angles; 87 percent of surviving patients were followed up at 5 years.
- The core lab reported no type 1 or type 3 endoleaks in any annual CT imaging follow up after the first year.
- 60 percent of angled neck patients had significant aneurysm sac shrinkage at 5 years. Low angle patients had similar outcomes, illustrating the tolerance of Aorfix to extreme angulation.
- All-cause mortality, aneurysm-related mortality, secondary intervention and aneurysm rupture rates over 5 years were compared with the Lifeline Registry of U.S. EVAR trials in normal anatomy and were found to be equivalent. There were no significant differences between Aorfix results in standard and highly angulated necks.
