European Journal of Vascular & Endovascular Surgery
Volume 33, Issue 2 , Pages 172-176 , February 2007

Impact of Study Design on Outcome after Endovascular Abdominal Aortic Aneurysm Repair. A Comparison between the Randomized Controlled DREAM-trial and the Observational EUROSTAR-registry

  • L.J. Leurs

      Affiliations

    • EUROSTAR Data Registry Center, Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands
    • Corresponding Author InformationCorresponding author. L.J. Leurs, MSc, Department of Vascular Surgery, Catharina Hospital, PO box 1350, 5602 ZA Eindhoven, The Netherlands.
  • ,
  • J. Buth

      Affiliations

    • EUROSTAR Data Registry Center, Department of Vascular Surgery, Catharina Hospital, Eindhoven, The Netherlands
  • ,
  • P.L. Harris

      Affiliations

    • Regional Vascular Unit, Royal Liverpool University Hospital, Liverpool, United Kingdom
  • ,
  • J.D. Blankensteijn

      Affiliations

    • Department of Vascular Surgery, Radboud University Nijmegen Medical Centre, Nijmegen, The Netherlands

,Accepted 4 September 2006.

References 

  1. Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and hierarchy of research designs. N Engl J Med. 2000;342:1887–1892
  2. Benson K, Hartz A. A comparison of observational studies and randomized, controlled trials. N Engl J Med. 2000;342:1878–1886
  3. Solomon MJ, McLeod RS. Surgery and the randomised controlled trial: past, present and future. Med J Aust. 1998;169:380–383
  4. Prinssen M, Buskens E, Blankensteijn JD. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial: background, design and methods. J Cardiovasc Surg (Torino). 2002;43:379–384
  5. Harris PL, Buth J, Miahle C, Myhre H, Norgren L. The need for clinical trials of endovascular abdominal aortic aneurysm stent-graft repair: The EUROSTAR project. J Endovasc Surg. 1997;4:72–77
  6. Prinssen M, Verhoeven ELG, Buth J, Cuypers PWM, van Sambeek MRHM, Balm R, et al. A Randomized Trial Comparing Conventional and Endovascular Repair of Abdominal Aortic Aneurysms. N Engl J Med. 2004;351(16):1607–1618
  7. Blankensteijn JD, de Jong SECA, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SMM, et al. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med. 2005;352:2398–2405
  8. Blankensteijn JD, Lindenburg FP, van der Graaf Y, Eikelboom BC. Influence of study design on reported mortality and morbidity rates after abdominal aortic aneurysm repair. Br J Surg. 1998;85:1624–1630
  9. Chaikof EL, Blankensteijn JD, Harris PL, White GH, Zarins CK, Bernhard VM, et al. Reporting standards for endovascular aortic aneurysm repair. J Vasc Surg. 2002;35:1048–1060

PII: S1078-5884(06)00510-7

doi: 10.1016/j.ejvs.2006.09.011

European Journal of Vascular & Endovascular Surgery
Volume 33, Issue 2 , Pages 172-176 , February 2007