Endovascular stent graft linked with long-term positive outcomes in PYTHAGORAS trial

Three-year follow-up data from the PYTHAGORAS premarketing approval trial demonstrate that an endovascular stent graft was safe and effective in patients with abdominal aortic aneurysms with standard and challenging anatomies, researchers reported at the VEITHsymposium in New York.

The prospective, nonrandomized PYTHAGORAS trial included 218 patients, most of whom had neck angles between 60 and 90 degrees.

According to results presented by Mark F. Fillinger, MD, principal investigator of the trial, the endovascular stent graft (Aorfix, Lombard Medical, Inc.) showed 100% freedom from type I and III endoleaks, 92.9% freedom from aneurysm sac expansion, 92.9% freedom from device migration and 78.1% freedom from all-cause mortality in patients with 60- to 131-degree aortic neck angulations, according to a press release.

In patients with more standard neck anatomy, including neck angulations less than 60 degrees, freedom from sac expansion was 83%, freedom from device migration was 95.2% and freedom from all-cause mortality was 86.6%, according to the release.

Eighty percent of enrolled patients reached 5-year follow-up (69% with neck angulation ≥ 60 degrees). According to Kaplan-Meier analysis, freedom from AAA-related mortality was 96.5% and freedom from sac rupture was 98% 5 years, according to the release.

Lombard Medical, Inc. anticipates the publication of the 5-year outcomes in 2016, according to the release.