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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms.
- Monique Prinssen, Eric L G Verhoeven, Jaap Buth, Philippe W M Cuypers, Marc R H M van Sambeek, Ron Balm, Erik Buskens, Diederick E Grobbee, Jan D Blankensteijn, and Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group.
- Division of Vascular Surgery, Department of Surgery, University Medical Center, Utrecht, The Netherlands.
- N. Engl. J. Med. 2004 Oct 14; 351 (16): 160716181607-18.
BackgroundAlthough 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.MethodsWe 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.ResultsThe 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).ConclusionsOn 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.Copyright 2004 Massachusetts Medical Society.
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