The ENGAGE Registry Ten Year Outcomes with the Endurant Stent Graft System for Endovascular Abdominal Aortic Aneurysm Repair

Abstract

Objective: Long term performance of endovascular aneurysm repair has not been well studied. The Endurant Stent Graft Natural Selection Global Post-market Registry (ENGAGE) observational, multicentre, non-randomised, prospective global registry was used to assess long term outcomes in patients treated with the Endurant stent graft system (Medtronic, Santa Rosa, CA, USA).

Methods: Inclusion criteria were minimal and included patients who fell outside of the instructions for use guidance. Exclusion criteria were high probability of non-adherence to follow up requirements, or concurrent participation in another trial that could confound results. Clinical and imaging data were continuously collected to evaluate treatment efficacy through ten years.

Results: There were 1 263 patients enrolled in the ENGAGE registry, of whom 390 re-consented for follow up from more than five through ten years and constituted the extended follow up (FU) cohort. The other 873 patients made up the non-extended FU cohort. For the extended FU cohort from more than five through ten years, Kaplan-Meier rates of freedom from site reported that all cause mortality with 95% confidence intervals (95% CI) were 97.3% (95% CI 95.5 - 99.1%); and 75.7% (95% CI 70.4 - 81.0%) for freedom from clinical event committee adjudicated aneurysm related mortality, and 99.4% (95% CI 98.6 - 100%) for freedom from conversion to open surgical repair. From zero through ten years, these rates were 96.2% (95% CI 94.0 - 98.4%) for aneurysm rupture and 71.4% (95% CI 66.3 - 76.5%) for aneurysm related re-interventions. For the extended FU cohort in the first five years, freedom estimates were 99.2% (95% CI 98.4 - 100%) for aneurysm rupture and 83.6% (95% CI 79.9%, 87.3%) for aneurysm related re-interventions. Late re-interventions (n = 72) were associated with type Ia endoleaks (18/72), type II endoleaks (18/72), and type Ib endoleaks (16/72). At ten years, 64.1% of patients exhibited sac regression, 19.2% were sac stable, and 16.8% had sac expansion.

Conclusion: This is the first study to report long term outcomes of real world, global abdominal aortic aneurysm patients with the Endurant stent graft. Overall, long term efficacy and durability were observed in patients who survived beyond five years post-enrolment in the ENGAGE registry.

Keywords: All cause mortality; EVAR; Long term outcomes; Re-intervention.