A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms.
BACKGROUND
Although the initial results of endovascular repair of abdominal aortic aneurysms were promising, current evidence from controlled studies does not convincingly show a reduction in 30-day mortality relative to that achieved with open repair.


METHODS
We conducted a multicenter, randomized trial comparing open repair with endovascular repair in 345 patients who had received a diagnosis of abdominal aortic aneurysm of at least 5 cm in diameter and who were considered suitable candidates for both techniques. The outcome events analyzed were operative (30-day) mortality and two composite end points of operative mortality and severe complications and operative mortality and moderate or severe complications.


RESULTS
The operative mortality rate was 4.6 percent in the open-repair group (8 of 174 patients; 95 percent confidence interval, 2.0 to 8.9 percent) and 1.2 percent in the endovascular-repair group (2 of 171 patients; 95 percent confidence interval, 0.1 to 4.2 percent), resulting in a risk ratio of 3.9 (95 percent confidence interval, 0.9 to 32.9). The combined rate of operative mortality and severe complications was 9.8 percent in the open-repair group (17 of 174 patients; 95 percent confidence interval, 5.8 to 15.2 percent) and 4.7 percent in the endovascular-repair group (8 of 171 patients; 95 percent confidence interval, 2.0 to 9.0 percent), resulting in a risk ratio of 2.1 (95 percent confidence interval, 0.9 to 5.4).


CONCLUSIONS
On the basis of the overall results of this trial, endovascular repair is preferable to open repair in patients who have an abdominal aortic aneurysm that is at least 5 cm in diameter. Long-term follow-up is needed to determine whether this advantage is sustained.
Prinssen
Monique
M
Division of Vascular Surgery, Department of Surgery, University Medical Center, Utrecht, The Netherlands.
Verhoeven
Eric L G
EL
Buth
Jaap
J
Cuypers
Philippe W M
PW
van Sambeek
Marc R H M
MR
Balm
Ron
R
Buskens
Erik
E
Grobbee
Diederick E
DE
Blankensteijn
Jan D
JD
D000368:Aged; D017130:Angioplasty / Q000401:mortality; D017544:Aortic Aneurysm, Abdominal / Q000401:mortality / Q000601:surgery*; D001807:Blood Vessel Prosthesis; D017558:Elective Surgical Procedures; D005260:Female; D006801:Humans; D008297:Male; D011183:Postoperative Complications; D016896:Treatment Outcome; D014656:Vascular Surgical Procedures / Q000379:methods* / Q000401:mortality