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Original Article
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Volume 351:1607-1618 October 14, 2004 Number 16
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A Randomized Trial Comparing Conventional and Endovascular Repair of Abdominal Aortic Aneurysms
Monique Prinssen, M.D., Eric L.G. Verhoeven, M.D., Jaap Buth, M.D., Philippe W.M. Cuypers, M.D., Marc R.H.M. van Sambeek, M.D., Ron Balm, M.D., Erik Buskens, M.D., Diederick E. Grobbee, M.D., Jan D. Blankensteijn, M.D., for the Dutch Randomized Endovascular Aneurysm Management (DREAM)Trial Group

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 by Lederle, F. A.

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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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From the Division of Vascular Surgery, Department of Surgery (M.P., J.D.B.), and the Julius Center for Health Sciences and Primary Care (E.B., D.E.G.), University Medical Center, Utrecht; the Division of Vascular Surgery, Department of Surgery, Academic Hospital, Groningen (E.L.G.V.); the Department of Surgery, Catharina Hospital, Eindhoven (J.B., P.W.M.C.); the Division of Vascular Surgery, Department of Surgery, Erasmus Medical Center, Rotterdam (M.R.H.M.S.); the Division of Vascular Surgery, Department of Surgery, Academic Medical Center, Amsterdam (R.B.); and the Department of Vascular Surgery, Radboud University, Nijmegen Medical Center, Nijmegen (J.D.B.) — all in the Netherlands.

Address reprint requests to Dr. Blankensteijn at the Department of Vascular Surgery (410), Radboud University, Nijmegen Medical Center, P.O. Box 9101, 6500 HB Nijmegen, the Netherlands, or at j.blankensteijn{at}chir.umcn.nl.

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