Five-year outcomes of the PYTHAGORAS U.S. clinical trial of the Aorfix endograft for endovascular aneurysm repair in patients with highly angulated aortic necks

PYTHAGORAS Investigators

Research output: Contribution to journalArticlepeer-review

Abstract

Objective Early and midterm outcomes of the Prospective Aneurysm Trial: High Angle Aorfix Bifurcated Stent Graft (PYTHAGORAS) trial in patients with highly angulated aortic necks (≥60 degrees) have already been published and shown comparable outcomes to other endografts in normal anatomy. Herein, we present the long-term outcomes of the PYTHAGORAS trial of Aorfix (Lombard Medical, Irvine, Calif) for patients with highly angulated aortic neck anatomy. Methods The Aorfix endograft is a highly conformable nitinol/polyester device designed for transrenal fixation. The U.S. trial enrolled 218 patients and observed all patients at 1 month, 6 months, and 12 months and then annually for a total of 5 years. Endovascular aneurysm repair (EVAR)-specific complications were compared between the standard-angle (<60 degrees) and highly angulated (≥60 degrees) neck groups at 5 years using standard statistical methods. Kaplan-Meier analysis was performed to evaluate the overall 5-year survival and freedom from aneurysm rupture, aneurysm-related mortality, and reintervention. Results Of the 218 patients enrolled in the trial, there were 67 patients in the standard-angle neck group (I) and 151 patients in the highly angulated neck group (II). Mean proximal neck angle was 45 degrees in group I vs 83 degrees in group II (P <.001). At 5 years, 87% of surviving patients were followed up. The 5-year EVAR-specific results showed no type I or type III endoleak in either group, 4% migration in group I vs 3% in group II, and 4% sac expansion in group I vs 15.0% in group II (P ≥.27). The 5-year freedom from all-cause mortality was 69% (73% in group I vs 68% in group II; P =.43); from aneurysm-related mortality, 96% (99% vs 95%; P =.44); from aneurysm rupture, 99% (99% vs 99%; P = 1.0); and from device-related secondary intervention, 83% (88% vs 80%; P =.18). None of these differed between groups. Conclusions The U.S. PYTHAGORAS trial of the Aorfix endograft is the first EVAR clinical trial to include a majority of highly angulated (≥60 degrees) infrarenal aortic necks and is the first to produce evidence after 5 years of implantation. Despite predictors of worse short- and long-term outcomes, pertinent outcomes were better than or similar to those of trials with less severe anatomy. These results support the use of this “on-label” endovascular option, particularly in patients with highly angulated aortic neck anatomy.

Original languageEnglish (US)
Pages (from-to)1598-1607
Number of pages10
JournalJournal of vascular surgery
Volume65
Issue number6
DOIs
StatePublished - Jun 2017

ASJC Scopus subject areas

  • Surgery
  • Cardiology and Cardiovascular Medicine

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