According to results from the PYTHAGORAS trial, a bifurcated stent graft showed positive outcome in patients suffering with abdominal aortic aneurysms. PYTHAGORAS trial was conducted to determine the safety and efficacy of the Aorfix stent graft in a treatment for repairing infrarenal abdominal aortic aneurysm (AAA). Mahmoud B. Malas, MD, revealed the findings of the study at the Society for Vascular Surgery, 2016 Vascular Annual Meeting in National Harbor, Maryland. He is the director of endovascular surgery and an associate professor of surgery at Johns Hopkins Bayview Medical Center. Lombard Medical Inc. funded this study, titled, “Prospective aneurysm trial: High angle Aorfix bifurcated stent graft.”
“The U.S. PYTHAGORAS trial is the first [endovascular aneurysm repair] clinical trial to include a majority of highly angulated (> 60°) infra-renal aortic necks as well as a higher percentage of female patients (29%),” Malas said, in a press release issued by Lombard Medical. “Moreover, the suitability of patients to be included was determined by the investigators rather than the company, resulting in many more ‘real-world’ cases being recruited.”
According to the press release, high neck angles have been linked
to worst outcomes in endovascular aneurysm repair (EVAR) system in females. 218
patients enrolled for the study and 151 out of 2018 had highly angulated necks.
87% of the surviving patients had follow-up of five years. At the end of the
first year, a core lab gave no judgment and did not release reports of type 1
or type 3 endoleaks in CT imaging.
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At the end of five years, no new cases of type 1 or type 3 endoleak were found. According to the researchers, a migration rate of the group with normal-angle necks was 4% and a sac expansion rate was also 4%. On the other hand, a migration rate of the group with higher-angle necks was 5.1% and a sac expansion rate was 15.3%. Researchers did not report any statistically significant differences at the end of five years.
According to the release, aneurysm-related mortality, at the end of five years, all-cause mortality, and aneurysm-rupture rates were equivalent to the EVAR trials of Lifeline registry of the U.S. conducted in normal anatomy. Furthermore, Malas and colleagues reported that freedom from sac rupture was 98%, freedom from all-cause mortality was 64%, freedom from aneurysm-related mortality was 96.5%, and freedom from secondary intervention was 81% at the end of five years.
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