Five-year report of a multicenter controlled clinical trial of open versus endovascular treatment of abdominal aortic aneurysms
Received 12 July 2006; accepted 8 January 2007. published online 31 March 2007.
Objective
Compare long-term results of endovascular treatment and standard open repair of abdominal aortic aneurysms in a multicenter, concurrent-controlled trial.
Methods
334 subjects were treated with standard open repair (control, n = 99) or the original EXCLUDER Bifurcated Endoprosthesis (test, n = 235). Five-year clinical evaluations and corelab radiographic results are analyzed.
Results
Overall and aneurysm-related survival are similar. There have been ten open conversions, most frequently for enlarging sacs without endoleak. Two patients died after conversion. Including reinterventions and complications of reinterventions as adverse events, there is significant, persistent long-term reduction in major adverse events. At 5 years, corelab reported 0% limb narrowing, 0% trunk migration, 0% component (contralateral leg, aortic extender, and iliac extender) migration, 0% fracture, endoleak in 3% (2 type II/68), and aneurysm growth (>5 mm compared to baseline) in 38% (30/78) of the test group. There are no aneurysm ruptures in either test or control group.
Conclusions
After 5 years follow-up, endovascular repair is a safer and effective treatment compared with open surgical repair for abdominal aortic aneurysms. Major adverse events are less frequent with the endograft despite the need for late reinterventions. Aneurysm expansion is observed in nearly two-fifths of patients but is not associated with endoleak or aneurysm rupture. Multicenter clinical trials are evaluating a newer version of this device designed to avoid this high rate of sac expansion.
Reprint requests: Jon S. Matsumura, MD, Department of Surgery, Northwestern University Feinberg School of Medicine, Suite 10-105, 251 E. Huron St, Chicago, IL 60611.
Competition of interest: Dr Matsumura has been a paid consultant, clinical investigator, and/or received support from Abbott, Bard, Cook, Cordis, ev3, Medtronic, and WL Gore.
ABSTRACT