May 29, 2019
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Endovascular, open repair confer similar long-term survival in AAA

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Frank Lederle
Frank A. Lederle

In long-term results from the OVER trial, patients with abdominal aortic aneurysm who had elective endovascular repair had similar survival rates compared with those who had elective open repair, which contradicted findings of other studies, researchers reported.

“This should be good news for patients because the endovascular procedure is less painful and has a much shorter recovery period than the open procedure, though it is more expensive,” investigator Julie Ann Freischlag, MD, CEO of Wake Forest Baptist Health, dean of Wake Forest School of Medicine and professor of vascular and endovascular surgery, said in a press release. “Earlier studies conducted more than a decade ago in Europe had indicated long-term problems with the endograft used in the less-invasive procedure. As a result, it isn't readily available for everyone in Europe and other parts of the world. Hopefully our study will dispel some of the concerns from the earlier studies and provide the scientific evidence to warrant a second look by the medical community.”

Endovascular vs. open repair

The researchers randomly assigned 881 patients undergoing elective AAA at a Veterans Affairs center between October 2002 and April 2008 to endovascular or open repair. The primary outcome was all-cause mortality. Patients were followed for as long as 14.2 years (mean, 8.4 years; median, 9.4 years).

During the study period, 68% of patients in the endovascular group and 70% of those in the open group died (HR = 0.96; 95% CI, 0.82-1.31), Frank A. Lederle, MD, and colleagues wrote in The New England Journal of Medicine. Lederle, who died in January 2018, was director of the Minneapolis VA Center for Epidemiological and Clinical Research and professor of medicine at the University of Minnesota School of Medicine.

Survival was higher in the endovascular group during the first 4 years, in the open group between 4 and 8 years, and again in the endovascular group after 8 years, although at no point was the difference statistically significant, the researchers wrote.

Aneurysm-related deaths occurred in 2.7% of the endovascular group and 3.7% of the open group (between-group difference, 1 percentage point; 95% CI, –3.3 to 1.4), and most such deaths occurred in the perioperative period, according to the researchers.

Aneurysm rupture happened in 1.6% of the endovascular group vs. 0.2% of the open group (between-group difference, 1.3 percentage points; 95% CI, 0.1-2.6).

Age differences

“For younger patients or for those who had extensive heart disease, the endovascular procedure was somewhat better,” Freischlag said in the release. “Open surgery was a better option for older patients, which was just the opposite of what we expected.”

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Death from chronic obstructive lung disease occurred more often in the open group (5.4% vs. 8.2%; (between-group difference, –2.8 percentage points; 95% CI, –6.2 to 0.5) and secondary procedures were required more often in the endovascular group (26.7% vs. 19.6%; between-group difference, 6.9 percentage points; 95% CI, 2-17.5), the researchers wrote.

“Our results were not consistent with the findings of worse performance of endovascular repair with respect to long-term survival that was seen in the two European trials,” Lederle and colleagues wrote. “The OVER trial required investigators performing the procedures to have specific skills as well as device training and trial-associated training to avoid potential increased mortality resulting from inexperience.” – by Erik Swain

Disclosures: The study was funded by the Department of Veteran Affairs Office of Research and Development. Freischlag and Lederle report no relevant financial disclosures. Please see the study for the other authors’ relevant financial disclosures.