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
Background Although the initial results of endovascular repairof abdominal aortic aneurysms were promising, current evidencefrom controlled studies does not convincingly show a reductionin 30-day mortality relative to that achieved with open repair.
Methods We conducted a multicenter, randomized trial comparingopen repair with endovascular repair in 345 patients who hadreceived a diagnosis of abdominal aortic aneurysm of at least5 cm in diameter and who were considered suitable candidatesfor both techniques. The outcome events analyzed were operative(30-day) mortality and two composite end points of operativemortality and severe complications and operative mortality andmoderate or severe complications.
Results The operative mortality rate was 4.6 percent in theopen-repair group (8 of 174 patients; 95 percent confidenceinterval, 2.0 to 8.9 percent) and 1.2 percent in the endovascular-repairgroup (2 of 171 patients; 95 percent confidence interval, 0.1to 4.2 percent), resulting in a risk ratio of 3.9 (95 percentconfidence interval, 0.9 to 32.9). The combined rate of operativemortality and severe complications was 9.8 percent in the open-repairgroup (17 of 174 patients; 95 percent confidence interval, 5.8to 15.2 percent) and 4.7 percent in the endovascular-repairgroup (8 of 171 patients; 95 percent confidence interval, 2.0to 9.0 percent), resulting in a risk ratio of 2.1 (95 percentconfidence interval, 0.9 to 5.4).
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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