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Infrarenal endograft for AAA confers favorable results at 5 years

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Among patients with abdominal aortic aneurysm, treatment with an infrarenal endograph was safe and effective at 1 year and continued to show acceptable results at 5 years, according to new data from the INSPIRATION trial.

As Cardiology Today’s Intervention previously reported, the device (Incraft, Cordis) was recommended for approval in June 2018 on the basis of data from INSPIRATION, and approved by the FDA in November.

Michel S. Makaroun, MD, chair of vascular surgery and co-director of the UPMC Heart and Vascular Institute at the University of Pittsburgh Medical Center, presented the 5-year results at the Society for Vascular Surgery Vascular Annual Meeting.

The primary safety endpoint, freedom from major adverse events at 30 days, occurred in 3.2% of patients, (95% CI, 0-61) and the primary effectiveness endpoint, successful aneurysm treatment at 1 year, occurred in 87.9% of patients (95% CI, 83-100), both of which met prespecified thresholds, Makaroun said.

Among the cohort, 44.4% had minimum access vessel diameter less than 7 mm, according to the researchers. Compliance with follow-up was excellent at 5 years; 93% had clinical follow-up and 84% had CT imaging.

There was only one rupture, at 5 years and 9 months, but none during the 5-year follow-up, Makaroun said. There was only one aneurysm-related mortality, which was due to an MI within 30 days, he said. He also noted two patients required conversion to open surgery.

Among patients with abdominal aortic aneurysm, treatment with an infrarenal endograph was safe and effective at 1 year and continued to show acceptable results at 5 years, according to new data from the INSPIRATION trial.

Source: Adobe Stock

At 5 years, 42.1% of patients had sac regression, 2.9% had a type I endoleak and 34% had a type II endoleak, according to the researchers. Of 190 patients, implanted limb occlusions were noted in seven at 1 year (3.7%) with four more over the next 4 years. Core lab analysis showed stent fractures in 20 patients, but none were associated with type 1a endoleaks or migrations at the proximal neck.

“The INSPIRATION study confirmed favorable safety and effectiveness of the Incraft device over a 5-year follow-up period with a remarkably low aneurysm-related mortality,” Makaroun and colleagues wrote in an abstract. – by Erik Swain