1. The EVAR I trial compared the safety and efficacy of endovascular and open abdominal aortic aneurysm repair
2. There were no significant differences in all-cause mortality between the two groups.
3. The endovascular group experienced significantly higher rates of graft-related complications and reinterventions.
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. Several randomized controlled trials have demonstrated benefits of endovascular repair with regards to 30-day mortality, and it has become increasingly used to manage patients with abdominal aortic aneurysm. There was, however, a paucity of data with regards to the long-term follow-up of endovascular repairs. The EVAR I trial was a landmark study that compared mortality and graft-related complication/reintervention rates in patients who had undergone endovascular and open aortic aneurysm repairs.
There were no significant differences between the two groups in terms of all-cause mortality. While early aneurysm-related mortality (i.e., 0-6 months after repair) was significantly lower in the endovascular repair group, this trend reversed in the longer run. More than 4 years after the repair, the endovascular repair group had significantly higher aneurysm-related mortality than the open group. Moreover, there were significantly higher rates of graft-related complications and reinterventions in the endovascular repair group.
In-Depth [randomized, controlled study]: The EVAR I trial, originally published in 2010 in NEJM, compared endovascular and open methods for abdominal aortic 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, had an abdominal aortic aneurysm with a diameter of at least 5.5 cm on computed tomography, and were anatomically and clinically suitable for either endovascular or open repair. Eligible participants were then randomized to receive either endovascular or open aneurysm repair. The primary outcome was all-cause mortality, while other outcomes were aneurysm-related mortality, graft-related complications, and graft-related reinterventions.
A total of 1,252 patients were recruited for the trial from 37 hospitals across the UK. Approximately 90.7% of the study participants were male. There were no significant differences between the two groups in all-cause mortality at any timepoint. With regards to aneurysm-related mortality, there were significantly fewer deaths in the endovascular repair group until 6 months after the repair (adjusted HR 0.47; 95% CI 0.23-0.93), though this difference was not observed 6 months to 4 years after the repair. More than 4 years after the repair, there were significantly more aneurysm-related deaths in the endovascular groups compared to the open repair group (adjusted HR 4.85; 95% CI 1.04-22.72). There were significantly higher rates of graft-related complications and reinterventions in the endovascular repair group compared to the open group.
By Adrienne Cheung, Andrew Cheung, M.D.
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