New data from the ENGAGE registry presented at the VEITHsymposium (New York, USA) show no migration at three years with the Endurant II AAA stent graft system from Medtronic. The results with the device also showed 1.5% rate of type I/III endoleak.
The global, real world ENGAGE registry enrolled more than 1,200 endovascular aneurysm repair patients at 79 sites across six continents since the Endurant system received the CE mark in June 2008.
Results for the 500 registry patients evaluated out to three years show that graft-related complications were low, with a 0% migration rate and a type I/III endoleak rate of 1.5%. Additionally, they show 90.7% freedom from secondary endovascular procedures and 98.4% freedom from aneurysm-related mortality. Positive results were also presented for the full 1,263 patient cohort evaluated at two years of follow-up.
According to Medtronic, a rigorous monitoring protocol has resulted in follow-up compliance of more than 90% in the ENGAGE registry, which is unprecedented for any registry and improves the reliability of the data.
“The size and scope of the ENGAGE registry distinguish Medtronic among stent graft makers as a committed partner in building the clinical evidence portfolio for EVAR worldwide,” said ENGAGE investigator Dittmar Böckler, University Hospital of Heidelberg in Germany, who presented the data. “It is especially compelling to see that at three years the Endurant system has maintained durable, long-term outcomes in treating abdominal aortic aneurysms in a real-world cohort that represents the types of challenging anatomies physicians encounter in daily clinical practice.”
Overall, durable results were sustained across a range of patient anatomies, including patients with more hostile aortic necks, which have historically been associated with limited eligibility for endovascular repair and higher rates of adverse events. The Endurant system is approved for use in patients with neck lengths of 10mm or greater.
Additional analysis of the patient cohort revealed that 18% of patients enrolled had anatomical characteristics that did not fall within the current instructions for use (IFU), further suggesting that the findings are relevant and applicable to current clinical practice. In addition, 16% of patients had symptomatic abdominal aortic aneurysms and 10.5% were female, representing the single largest cohort of females in any EVAR trial (n=133).