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Two studies report encouraging results for AAA stent graft system

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Two studies presented at the 2014 Charing Cross International Symposium in London showed strong outcomes associated with the Endurant stent graft system among patients with abdominal aortic aneurysms.

The first study, PANDORA, included 277 consecutive patients who were enrolled prospectively between November 2007 and December 2010 and treated with the Endurant abdominal aortic aneurysm (AAA) stent graft system (Medtronic). There were no exclusion criteria. Patients had neck lengths of 10 mm to less than 15 mm, with 7% experiencing symptomatic aneurysms and 2% with ruptured aneurysms.

The rate of AAA-related reintervention was 9.5% during the follow-up period (median, 42.1 months). Five-year follow-up results indicated an 87% rate of freedom from secondary intervention.

There was no proximal migration of the stent graft, only 2% type I/III endoleaks and one death related to AAA (0.3%).

In the second study, ENGAGE, researchers enrolled more than 1,200 patients requiring endovascular aneurysm repair (EVAR) from 79 centers around the world to investigate whether neck length impacts outcomes with the Endurant AAA stent graft system at 3 years.

Forty-eight patients were included with neck lengths of 10 mm to <15 mm, 79 had neck lengths of 15 mm to <20 mm and 364 patients had neck lengths ≥20 mm.

Strong outcomes were reported in patients with neck lengths of 10 mm to <15 mm and those with neck lengths of 15 mm or greater.

Rates of aneurysm rupture were 0% for both the shortest neck length groups and 0.3% for the longest group. For conversion to open surgery, the two shortest length groups also had 0% rates, while the rate for the longest neck length group was 1.1%.

Secondary endovascular procedures occurred in 4.2% of the 10 mm to <15 mm group, 10.1% of the 15 mm to <20 mm group and 8.5% of the ≥20 mm group. No patients in the shortest group required a secondary endovascular procedure to correct type I/III endoleak, whereas this procedure was required in 1.3% of patients in the medium length group and 3% of those in the longest neck length group. There was no stent graft migration in any study arm.

“The Endurant stent graft has opened up standard EVAR to patients who were previously considered ineligible, and the ENGAGE results support the usage of this device in patients with short necks (10 mm and up),” Hence Verhagen, MD, PhD, from Erasmus Medical Center in Rotterdam, the Netherlands, said in a press release. “The data also show that the Endurant stent graft successfully broadens patient eligibility for standard EVAR.”