Lombard today announced the high angle clinical data results from the US PYTHAGORAS trial of its endovascular stent graft Aorfix. Data suggest that Aorfix has the potential to provide a less invasive treatment option for abdominal aortic aneurysm patients with highly angulated neck anatomy.
The unique data set, presented at the Society of Vascular Surgery (SVS) Annual Meeting (7–9 June, USA) by Mark Fillinger of Dartmouth Hitchcock Medical Centre, New Hampshire, USA, featured results from the world’s first and largest multicentre EVAR clinical trial studying patients with angles greater than 60 degrees.
Two hundred and five patients were recruited in the trial and the data resulted from 143 patients with highly-angulated aortic necks (angles between 60 and 110 degrees). Treatment of this patient group is not indicated in any stent grafts currently available in the USA.
The data presented showed that Aorfix performed well in extreme aortic neck angulations. Outcomes such as freedom from major adverse events (MAEs, as defined by the SVS) at 30 days and 365 days, were significantly lower than in patients undergoing open surgical repair (81.1% vs. 56.4%, p<0.0001 and 75.5% vs. 54.5%, p<0.0001 respectively). Although not tested in this trial, Fillinger noted that the outcomes were similar to EVAR trials of other stent grafts in much less severe anatomy.
The PYTHAGORAS trial’s results were achieved despite the inclusion of patients with predictors of worse short and long-term outcomes such as:
- age (75.4+/-8 years vs. 69.2 +/-7 years, p=0.001);
- proportion of female patients (35% vs. 20%, p=0.015);
- congestive heart failure (14% vs. 4%, p=0.029); and
- high neck angles (83+/-15 degrees, compared to SVS control group: 48+/-22 degrees, p<0.05)
“Aorfix has produced promising results in this extremely challenging patient group with high neck angles whose only treatment option currently is open surgical repair. Once available in the US, Aorfix should provide clinicians with a versatile option for treating patients with challenging abdominal aortic aneurysm anatomy, significantly expanding our ability to treat this condition in a minimally invasive fashion,”Fillinger said.
Simon Hubbert, chief executive of Lombard Medical said, “We are very pleased with the US PYTHAGORAS data, further evidence that Aorfix is an excellent treatment option for patients with extremely tortuous anatomy and who previously had no endovascular options. Our work supporting the US approval process for Aorfix is on track and we continue to anticipate US approval by the end of the year.”
Aorfix is currently commercially available in Europe and Lombard expects to launch the stent graft in the USA later this year, subject to FDA approval.