The EVAR II trial: Endovascular approach when unfit for open aortic aneurysm repair [Classics Series]

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1. The EVAR II trial compared endovascular abdominal aortic aneurysm repair with no intervention in patients unsuitable for the open procedure.

2. There were significantly fewer aneurysm-related deaths in the endovascular group, compared to no intervention.

3. The rates of complication and reintervention were similar to the rates observed in EVAR I.

Original Date of Publication: May 20, 2010

The Endovascular Aneurysm Repair (EVAR) trials were randomized controlled trials conducted to explore the safety and efficacy of repairing abdominal aortic aneurysms using endovascular methods. Two trials were conducted simultaneously and published in the same issue of The New England Journal of Medicine.

Study Rundown: Endovascular aortic aneurysm repair was first introduced in the late 1980s as an alternative for people considered unfit for open surgery.  The purpose of the EVAR II trial was to assess the benefits and risks associated with endovascular aortic aneurysm repair in patients who were unfit for the open procedure. There were no significant differences between the two groups in terms of all-cause mortality, though aneurysm-related mortality was significantly lower in the endovascular repair group. This benefit was largely attributed to the significant reductions observed in the 6 month to 4 year period following the repair procedure. Notably, the graft-related complication and reintervention rates were comparable to those observed in the EVAR I trial.

Please click to read study in NEJM

In-Depth [randomized, controlled study]: The EVAR II trial, originally published in 2010 in NEJM, focused on patients who were physically unsuitable for open abdominal aneurysm repair. The trial was supported by the National Institute for Health Research of the United Kingdom (UK). Patients were eligible for the trial if they were at least 60 years of age and had an abdominal aortic aneurysm with a diameter of at least 5.5 cm on computed tomography. Moreover, eligible patients were unsuitable for open repair, but candidates for endovascular repair. Eligible participants were then randomized to receive either endovascular aneurysm repair or no intervention. Again, the primary outcome was all-cause mortality, while other outcomes were aneurysm-related mortality, graft-related complications, and graft-related reinterventions.

A total of 404 patients were recruited from 33 different hospitals across the UK.  Approximately 86% of the participants were male. With regards to all-cause mortality, there were no significant differences between the two groups at any timepoint following the repair. Notably, there were significantly fewer aneurysm-related deaths in the endovascular group compared to the no intervention group (adjusted HR 0.53; 95% CI 0.32-0.89). This difference was driven by significant reductions in mortality in the 6 month to 4 year period following repair (adjusted HR 0.34; 0.16-0.72). In total, 158 graft-related complications and 66 graft-related interventions were observed during the trial, and these rates were comparable to the rates observed in the EVAR I trial.

By Adrienne Cheung, Andrew Cheung, M.D.

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