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The Journal of Cardiovascular Surgery 2019 Jul 09

DOI: 10.23736/S0021-9509.19.11021-X


lingua: Inglese

Improvements in patient outcomes with next generation endovascular aortic repair devices in the engage global registry and the EVAR-1 clinical trial

Dittmar BÖCKLER 1 , Adam H. POWER 2, Lee H. BOUWMAN 3, Steven van STERKENBURG 4, Marc BOSIERS 5, Patrick PEETERS 6, Joep A. TEIJINK 7, Hence J. VERHAGEN 8, on behalf of the ENGAGE investigators

1 University Hospital Heidelberg, Heidelberg, Germany; 2 Western University, London, ON, Canada; 3 Zuyderland Medisch Centrum Heerlen, Heerlen, the Netherlands; 4 Rijnstate Hospital, Arnhem, the Netherlands; 5 AZ Sint-Blasius-Campus, Dendermonde, Belgium; 6 Imelda Hospital, Bonheiden, Belgium; 7 CAPHRI Research School, Maastricht, the Netherlands; 8 Erasmus University Medical Center, Rotterdam, the Netherlands


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 United Kingdom 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.

KEY WORDS: ENGAGE registry; EVAR 1 trial; Data registry; Randomized controlled trial

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