Publication

A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms

Prinssen, M., Verhoeven, ELG., Buth, J., Cuypers, PWM., van Sambeek, MRHM., Balm, R., Buskens, E., Grobbee, DE., Blankensteijn, JD., Bak, AAA., Blankensteijn, JD. & DREAM Trial Grp, 14-Oct-2004, In : New England Journal of Medicine. 351, 16, p. 1607-1618 12 p.

Research output: Contribution to journalArticleAcademicpeer-review

  • M Prinssen
  • ELG Verhoeven
  • J Buth
  • PWM Cuypers
  • MRHM van Sambeek
  • R Balm
  • E Buskens
  • DE Grobbee
  • JD Blankensteijn
  • AAA Bak
  • JD Blankensteijn
  • DREAM Trial Grp

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.

Original languageEnglish
Pages (from-to)1607-1618
Number of pages12
JournalNew England Journal of Medicine
Volume351
Issue number16
Publication statusPublished - 14-Oct-2004

    Keywords

  • OPEN SURGICAL REPAIR, DECISION-ANALYSIS MODEL, COST-EFFECTIVENESS, CLINICAL-TRIALS, STENT-GRAFT, AAA REPAIR, MORTALITY, SURVEILLANCE, SURGERY, LIFE

ID: 4268340