Abstract
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
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