In a recent study in the NEJM, the authors examine whether elective endovascular repair of abdominal aortic aneurysm reduces long-term morbidity and mortality, as compared with traditional open repair (1).
The trial was funded by the Department of Veterans Affairs Office of Research and Development; ClinicalTrials.gov numberNCT00094575.881 patients with asymptomatic abdominal aortic aneurysms, who were candidates for both procedures, were randomly assigned to either endovascular repair (444) or open repair (437) and followed them for up to 9 years (mean 5.2). Patients were selected from 42 Veterans Affairs medical centers and were 49 years of age or older at the time of registration. Primary endpoint was all-cause mortality.
More than 95% of the patients underwent the assigned repair. 146 deaths occurred in each group (hazard ratio with endovascular repair versus open repair, 0.97; 95% confidence interval [CI], 0.77 to 1.22; P=0.81). The previously reported reduction in perioperative mortality with endovascular repair was sustained at 2 years (hazard ratio, 0.63; 95% CI, 0.40 to 0.98; P=0.04) and at 3 years (hazard ratio, 0.72; 95% CI, 0.51 to 1.00; P=0.05) but not thereafter. There were 10 aneurysm-related deaths in the endovascular-repair group (2.3%) versus 16 in the open-repair group (3.7%) (P=0.22). Six aneurysm ruptures were confirmed in the endovascular-repair group versus none in the open-repair group (P=0.03). A significant interaction was observed between age and type of treatment (P=0.006); survival was increased among patients under 70 years of age in the endovascular-repair group but tended to be better among those 70 years of age or older in the open-repair group.
The authors summarize that endovascular and open repair resulted in similar long-term survival. The perioperative survival advantage with endovascular repair was sustained for several years, but rupture after repair remained a concern. Endovascular repair led to increased long-term survival among younger patients but not among older patients, for whom a greater benefit from the endovascular approach had been expected.
As described in the accompanying editorial (2), the results expand data described in prior trials (3-5).
1. Frank A. Lederle, M.D., Julie A. Freischlag, M.D., Tassos C. Kyriakides, Ph.D., Jon S. Matsumura, M.D., Frank T. Padberg, Jr., M.D., Ted R. Kohler, M.D., PanagiotisKougias, M.D., Jessie M. Jean-Claude, M.D., Dolores F. Cikrit, M.D., and Kathleen M. Swanson, M.S., R.Ph. for the OVER Veterans Affairs Cooperative Study Group
Long-Term Comparison of Endovascular and Open Repair of Abdominal Aortic Aneurysm.N Engl J Med 2012; 367:1988-1997
2.Joshua A. Beckman, M.D. Is the Dream of EVAR Over?N Engl J Med 2012; 367:2041-2043
3. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, Lin PH, Jean-Claude JM, Cikrit DF, Swanson KM, Peduzzi PN; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group.Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.JAMA. 2009 Oct 14;302(14):1535-42.
4. LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm.
United Kingdom EVAR Trial Investigators, Greenhalgh RM, Brown NEngl J Med. 2010 May 20;362(20):1863-71.
5. De Bruin JL, Baas AF, Buth J, Prinssen M, Verhoeven EL, Cuypers PW, van Sambeek MR, Balm R, Grobbee DE, Blankensteijn JD; DREAM Study Group. Long-term outcome of open or endovascular repair of abdominal aortic aneurysm. N Engl J Med. 2010 May 20;362(20):1881-9.