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

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.