A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms.

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.