Evidence - Abdominal Aortic Aneurysm - Endovascular Therapy

• EVAR I Trial (Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm )
  Comparison of outcomes after open conventional vs. endovascular therapy of abdominal aortic aneurysms in the United Kingdom:
  The 30-day mortality was significantly reduced in endovascular therapy (1.6% vs. 4.6%), but the secondary intervention rate was increased (9.8% vs. 5.8%). 1
  In particular, the healthier patients benefited from it. 2
  Four years after randomization, the overall mortality was comparable (28% each), the aneurysm-associated mortality after endovascular therapy remained reduced (4% vs. 7%). The complication rate was significantly increased after endovascular therapy (41% vs. 9%). Quality of life did not differ significantly 1 year after surgery. The average hospital costs were higher after endovascular therapy (13257 UK pound sterling vs. 9946 UK pound sterling). 3
• EVAR II Trial (Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysm)
  Assessment of outcomes after endovascular therapy of abdominal aortic aneurysms in patients classified as too sick for a conventional approach, compared to a conservative approach (no intervention):
  The 30-day mortality after endovascular therapy was 9%, the rupture rate in untreated patients was 9/100 patient-years. After endovascular therapy, no significant improvement in overall mortality (64% after 4 years) or aneurysm-associated mortality was observed; however, it was considerably more expensive (13632 UK pound sterling vs. 4983 UK pound sterling). 4
• DREAM Trial (Dutch Randomised Endovascular Aneurysm Management)
  Comparison of outcomes after open conventional vs. endovascular therapy of abdominal aortic aneurysms in the Netherlands:
  Both the 30-day mortality (1.2% vs. 4.6%) and the combined rate of operative mortality and complications (4.7% vs. 9.8%) were significantly reduced after endovascular therapy. 5
  The cumulative survival rate was nearly identical 2 years postoperatively after both surgical procedures (endovascular 89.7% vs. 89.6%). The cumulative rate of aneurysm-associated deaths was 2.1% after endovascular therapy and 5.7% after conventional surgery. This difference was solely due to the difference in direct postoperative events. The proportion of patients who showed no complications after 2 years was comparable (65.9 vs. 65.6%). 6
  Following both surgical procedures, sexual function is impaired but recovers more quickly after endovascular therapy. After 3 months, the baseline situation is regained regardless of the approach. 7
  Quality of life is better in the early postoperative phase after endovascular therapy, which changes in favor of the conventional approach after 6 months and beyond. 8
  Endovascular therapy was more expensive by 4293€. 9
• OVER Trial (Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group)
  Comparison of outcomes after open conventional vs. endovascular therapy of abdominal aortic aneurysms in the USA:
  Endovascular therapy was associated with reduced perioperative mortality (0.5% vs. 3%), operative time (2.9 vs. 3.7 hours), blood loss (200 ml vs. 1000 ml), transfusion requirement (0 vs.1 unit), ventilation duration (3.6 vs. 5 hours), intensive care unit stay (1 vs. 4 days), and hospital stay (3 vs. 7 days). Regarding morbidity, treatment failure, secondary interventions, aneurysm-associated hospitalizations, quality of life, or erectile function, there were no differences between the therapy options. 10

• CAESAR Trial: Comparison of surveillance vs Aortic Endografting for Small Aneurysm Repair
  Comparison of ultrasound surveillance vs. early endovascular therapy of small (< 5.5 cm) abdominal aortic aneurysms
• PIVOTAL study: Positive Impact of endoVascular Options for Treating Aneurysm earLy
  Comparison of ultrasound surveillance vs. early endovascular therapy of small (< 5.5 cm) abdominal aortic aneurysms
• AJAX Trial: Acute endovascular treatment to improve outcome of ruptured aorto-iliac aneurysms
  Comparison of endovascular vs. open conventional therapy of ruptured abdominal aortic aneurysms
• ACE Trial: Anévrysme de l’aorte abdominale, Chirurgie versus Endoprothèse
  Comparison of endovascular vs. open conventional therapy of aortic aneurysms in patients with a good risk

For further ongoing studies see: www.controlled-trials.com

1. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR Trial Participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysms (EVAR I Trial), 30-day operative mortality results: randomised controlled trial. Lancet 2004;364(9437):843-8
2. Brown LC, Greenhalgh RM, Howell S, Powell JT, Thompson SG. Patient fitness and survival after abdominal aortic aneurysm repair in patients from the UK EVAR. Br J Surg 2007;94(6):709-16
3. EVAR Trial Participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysms (EVAR Trial I): randomised controlled trial. Lancet 2005; 365(9478):2179-86
4. EVAR Trial Participants. Endovascular aneurysm repair versus open repair in patients with abdominal aortic aneurysms (EVAR Trial II): randomised controlled trial. Lancet 2005; 365(9478):2187-92
5. Prinssen M, Verhoeven EL, Buth J, Cuypers PW, van Sambeek MR, Balm R, Buskens E, Grobbee DE, Blankensteijn JD; Dutch Randomized Endovascular Aneurysm Management(DREAM)Trial Group. A randomized trial comparing conventional and endovascular repair of abdominal aortic aneurysms. N Engl J Med 2004; 14;351(16):1607-18
6. Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM, Verhagen HJ, Buskens E, Grobbee DE; Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group. Two-year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med 2005; 352(23):2398-405
7. Prinssen M, Buskens E, Nolthenius RP, van Sterkenburg SM, Teijink JA, Blankensteijn JD. Sexual dysfunction after conventional and endovascular AAA repair: results of the DREAM trial. J Endovasc Ther. 2004;11(6):613-20
8. Prinssen M, Buskens E, Blankensteijn JD; DREAM trial participants. Quality of life endovascular and open AAArepair. Results of a randomised trial. Eur J Vasc Endovasc Surg 2004;27(2):121-7
9. Prinssen M, Buskens E, de Jong SE, Buth J, Mackaay AJ, van Sambeek MR, Blankensteijn JD; DREAM trial participants. Cost-effectiveness of conventional and endovascular repair of abdominal aortic aneurysms: results of a randomized trial. J Vasc Surg 2007;46(5):883-890
10. Lederle FA, Freischlag JA, Kyriakides TC, Padberg FT Jr, Matsumura JS, Kohler TR, Lin PH, Jean-Claude JM, Cikrit DF, Swanson KM, Peduzzi PN; Open Versus Endovascular Repair (OVER) Veterans Affairs Cooperative Study Group. Outcomes following endovascular vs open repair of abdominal aortic aneurysm: a randomized trial.JAMA. 2009;302(14):1535-42