A new peer reviewed article e-published in the Journal of Vascular Surgery highlights the clinical benefits of treating patients with Lombard Medical’s Aorfix endovascular stent graft.
The article was authored by one of the study investigators, Mahmoud Malas, associate professor of Surgery at Johns Hopkins School of Medicine in Baltimore, USA. The data was derived from the PYTHAGORAS pivotal study, which supported Food and Drug Administration approval of Aorfix. The controlled, prospective, non-randomised, multicentre study evaluated 218 patients, 151 of which had neck angles of 60 degrees or greater, of which a further severely angled subset of 42 had neck angles greater than 90 degrees. Lombard continues to collect data on safety and effectiveness for up to five years post-implant.
“As the only multicentre, prospective, controlled study of endovascular aortic repair (EVAR) in highly angled abdominal aortic aneurysm (AAA) anatomy, the PYTHAGORAS trial continues to provide a wealth of unique data,” said Malas. “We are very pleased with the clinical outcomes of Aorfix in all anatomies, particularly in severely angulated necks. Long term, the performance of Aorfix in these anatomies is impressive.”
The objective of the recently published study was to evaluate changes in aneurysm neck morphology (shape) over time after EVAR repair with the Aorfix endovascular stent graft. Study results revealed that the adverse event rate was lower for the standard, high, and severe neck angle groups when compared with the open surgical control group. Patient outcomes were equal to, or better than open repair, and similar to EVAR trials in patients with less severe anatomy.
Those results showed:
• 92.5% of patients in the standard neck angled group (less than 60 degrees), 83.5% in the highly angled group, and 76.2% in the severely angled neck groups had no (Society for Vascular Surgery defined) major adverse events in the first 30 days.
• Previous studies have shown a 30-day mortality rate of up to 20% and an adverse event rate of 70% in patients with hostile neck anatomy undergoing off-label EVAR repair.
In the only EVAR clinical trial where the majority of neck angles were over 60 degrees, the results demonstrate that Aorfix performed well in excluding aneurysms with both standard and highly angled aortic neck anatomy.
“These results continue to validate the clinical benefits of Aorfix in a wide range of aortic neck anatomies,” said Simon Hubbert, chief executive officer of Lombard. “We strongly believe in an evidence-based approach to treating AAA patients, and the outcomes from this important trial which are represented in this peer reviewed article support the use of Aorfix for many AAA cases.”