ORIGINAL ARTICLES  VASCULAR SECTION 

The Journal of Cardiovascular Surgery 2002 June;43(3):379-84

Copyright © 2009 EDIZIONI MINERVA MEDICA

lingua: Inglese

The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods

Prinssen M., Buskens E., Blankensteijn J. D.

From the Department of Vascular Surgery and *Julius Center for Health Sciences and Primary Care University Medical Center, Utrecht, The Netherlands

After ­the intro­duc­tion of endo­vas­cu­lar ­repair of abdom­i­nal aor­tic aneu­rysms (­AAA), ­both ben­e­fits ­and draw­backs of ­this ­new tech­nique ­have ­been report­ed. To ­assess wheth­er ­the ­new tech­nique is an ade­quate sub­sti­tute of con­ven­tion­al ­AAA ­repair, a ran­dom­ised ­study is ­due. The ­Dutch Randomised Endovascular Aneurysm Management (DREAM) ­trial is a ran­dom­ised mul­ti­cen­ter ­trial enroll­ing ­patients eli­gible ­for elec­tive treat­ment of infra­ren­al AAAs. In ­this ­study, ­the ­cost-effec­tive­ness of endo­vas­cu­lar aneu­rysm ­repair (­EAR) is com­pared ­with ­that of con­ven­tion­al trans­ab­dom­i­nal sur­gery, in ­patients ­that ­are con­sid­ered suit­able ­for ­both ­types of treat­ment. The pri­mary end­point is com­bined oper­a­tive mor­tal­ity ­and mor­bid­ity. Secondary end­points ­and addi­tion­al assess­ments ­include ­event ­free sur­vi­val, qual­ity of ­life, ­length of hos­pi­tal ­stay ­and ­costs. It is expect­ed ­that ­the ­DREAM-­trial ­will ­lead to a ­safe ­and con­trolled intro­duc­tion of a ­new tech­nol­o­gy. Also, ­the med­i­cal com­mu­nity ­will ­obtain val­id sci­en­tif­ic evi­dence of ­the mer­its of endo­vas­cu­lar ­AAA ­repair. Finally, pol­i­cy mak­ers ­will be pro­vid­ed ­with accu­rate ­cost-effec­tive­ness ­data ­for ­the Dutch health­care ­system. The ­aim of ­the ­present ­paper is to ­describe ­the back­ground, meth­ods ­and ­design of ­the ­DREAM-­trial.