Improvements in patient outcomes with next generation endovascular aortic repair devices in the ENGAGE Global Registry and the EVAR-1 clinical trial.

ABSTRACT

BACKGROUND: The outcomes from the randomized controlled trials (RCTs) comparing endovascular aortic aneurysm repair (EVAR) to open surgical repair (OSR) may no longer be reflective of currently technology. Here the EVAR-1 trial and the ENGAGE registry are examined to assess potential improvements in outcomes with modern stent graft systems. METHODS: EVAR-1 was a multicenter, prospective, randomized controlled trial in the UK and patients were enrolled between 1999 and 2004 and treated with first- and second-generation devices. ENGAGE is an observational, nonrandomized, prospective registry that completed enrollment between 2009 and 2011. All ENGAGE patients were treated with the Endurant AAA Stent Graft System. A descriptive comparison of the published four-year outcomes of all-cause mortality (ACM), aneurysm-related mortality (ARM), rupture after elective EVAR, and reinterventions are reported. RESULTS: Through the four-year timepoint, freedom from ACM was 74.4% in the EVAR-1 Trial and 74.6% in the ENGAGE registry. ARM in the EVAR-1 trial was 4.2% and in the ENGAGE registry was 1.9%. Death due to rupture through four years was 1.6% (10/626) and 0.5% (6/1263) in the EVAR-1 and ENGAGE patients, respectively. In the EVAR-1 trial, the proportion of patients requiring at least one reintervention through the four-year timepoint was 19.3% (121/626) whereas in the ENGAGE registry, reinterventions occurred in 10.9% (138/1263) of patients. CONCLUSIONS: EVAR patient outcomes have improved since the time of the original EVAR vs. OSR trials and data from real-world registries should be considered a primary resource for developing new guidelines for patient selection and management.