Medtronic announced data supporting the strength and durability of the Endurant II/IIs[i] stent graft system to treat abdominal aortic aneurysm patients. The results, presented during the 2016 VEITHsymposium (15–19 November, New York, USA), are based upon new subanalyses of Medtronic’s ENGAGE Global Registry. The registry has enrolled more than 1,200 patients at 79 sites across six continents. With 10-year follow-up planned for all patients, according to a press release, ENGAGE represents the most robust post-market registry ever initiated in the study of endovascular aortic repair (EVAR).
In a subanalysis of ENGAGE—presented for the first time—Hence Verhagen (chief of vascular surgery at Erasmus University Medical Center, Rotterdam, the Netherlands) reviewed the use of EVAR in patients with both standard and complex anatomies emphasising Type Ia endoleaks. In a finding based on the full registry cohort (n=1263), patients were free from Type Ia endoleaks for up to four years, with rates of 97.8% (one year), 97.3% (two years), 96.7%(three years), and 96% (four years). Similar results were seen in subanalyses of both standard and complex patients at all-time points.
Verhagen says: “The impact of a Type Ia endoleak is serious and includes an increased risk of rupture and the need for reintervention. This new analysis from the four-year global ENGAGE registry provides further evidence of the benefits of EVAR in patients with both standard and complex anatomies, and it reflects the low endoleak rates that can be achieved with the Endurant stent graft system.”
A second subanalysis of the ENGAGE registry data presented by Verhagen is one of the largest to date of long-term outcomes in patients (>100) with hostile aortic neck anatomy. The results showed that Endurant achieves positive results in patients with various hostile neck types followed up to four years. At four years these mid-term outcomes, such as aneurysm related mortality, rupture and conversion to open surgical repair, offer clinical insight into the treatment of abdominal aortic aneurysm neck anatomies that is relevant and applicable to current clinical practice and real-world settings. “Data from the ongoing global ENGAGE registry show positive outcomes in several anatomically challenging sub-groups, including those with hostile aortic necks,” adds Verhagen.
Additionally, ENGAGE investigator Dittmar Böckler (University of Heidelberg, Department of Vascular Surgery, Germany) reviewed data from the ENGAGE registry outcomes with reference to the flagship EVAR 1 study. These results, which were first presented at Charing Cross Symposium in April 2016, showed that Endurant was more effective than the previous generation of endografts evaluated in EVAR 1, with a 54% relative risk reduction in aneurysm-related mortality rates, a 44% relative risk reduction of rupture, and a 35% relative risk reduction in secondary interventions. The findings support use of Endurant in a wide range of patients.