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Randomized Trials: What is the Evidence?

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Abstract

Endovascular surgery for ruptured abdominal aortic aneurysms (rAAA) was first described in 1994, but only recently has there been robust evidence to support it as a definite alternative to open surgical repair. Randomized controlled trial evidence comes in the form of the AJAX, ECAR, and IMPROVE trials, with the latter mirroring current clinical practice most closely. IMPROVE has shown that endovascular surgery for rAAA is as effective as open surgical repair, allows for shorter hospital stays, offers a greater advantage for women, and is cost-effective, and these results have been borne out in an individual patient meta-analysis of all three studies. It is vital in the modern era that centers offering repair of rAAA should offer both open surgical and endovascular approaches to patients appropriately. Analysis of results with reference to aortic morphology has demonstrated that the biggest future gains in mortality are likely to occur in patients with short aortic necks, and this is an area that should be the focus of development in open and endovascular repair.

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Notes

  1. 1.

    Four patients in the Endovascular Strategy group had an attempt at EVAR, but required conversion to open repair. All 4 died within 30 days. These 4 patients were included in the EVAR deaths but not in the open repair deaths in the Endovascular Strategy group calculations. However, in the calculations of the overall 30-day mortality rates for the two randomized groups taken together, these 4 patients were excluded from the EVAR deaths and included in the open repair deaths. If these 4 patients were included in the EVAR deaths and excluded from the open repair deaths in the calculations for the combined groups, the 30-day mortalities would have been 26.3 % (50/190) for EVAR and 37.3 % (124/332) for open repair (p = 0.01).

References

Randomized Trials: What Is the Evidence?

  1. Björck M. Surgery for ruptured abdominal aortic aneurysm. BMJ. 2014;348.

    Google Scholar 

  2. Desgranges P, Kobeiter H, Castier Y, Senechal M, Majewski M, Krimi A. The Endovascularie vs Chirurgie dans les Aneurysmes Rompus Protocol trial update. J Vasc Surg. 2010;51(267):70.

    Google Scholar 

  3. Desgranges P, Kobeiter H, Katsahian S, Bouffi M, Gouny P, Favre JP, Alsac JM, Sobocinski J, Julia P, Alimi Y, Steinmetz E, Haulon S, Alric P, Canaud L, Castier Y, Jean-Baptiste E, Hassen-Khodja R, Lermusiaux P, Feugier P, Destrieux-Garnier L, Charles-Nelson A, Marzelle J, Majewski M, Bourmaud A, Becquemin JP. Editor’s Choice – ECAR (Endovasculaire ou Chirurgie dans les Anevrysmes aorto-iliaques Rompus): a french randomized controlled trial of endovascular versus open surgical repair of ruptured aorto-iliac aneurysms. Eur J Vasc Endovasc Surg. 2015;50(3):303–10.

    Article  CAS  PubMed  Google Scholar 

  4. Egorova N, Giacovelli J, Greco G, Gelijns A, Kent CK, McKinsey JF. National outcomes for the treatment of ruptured abdominal aortic aneurysm: comparison of open versus endovascular repairs. J Vasc Surg. 2008;48(1092):100.

    Google Scholar 

  5. Hinchliffe RJ, Bruijstens L, MacSweeney ST, Braithwaite BD. A randomised trial of endovascular and open surgery for ruptured abdominal aortic aneurysms—results of a pilot study. Eur J Vasc Endovasc Surg. 2006;5(506):13.

    Google Scholar 

  6. Holt PJ, Karthikesalingam A, Poloniecki JD, Hinchliffe RJ, Loftus IM, Thompson MM. Propensity scored analysis of outcomes after ruptured abdominal aortic aneurysm. Br J Surg. 2010;97(496):503.

    Google Scholar 

  7. Hoornweg LL, Storm-Versloot MN, Ubbink DT, Koelemay MJ, Legemate DA, Balm R.Meta analysis on mortality of ruptured abdominal aortic aneurysms. Eur J Vasc Endovasc Surg. 2008;35(5):558–70.

    Google Scholar 

  8. Investigators IMPROVE Trial. The effect of aortic morphology on perioperative mortality of ruptured abdominal aortic aneurysm. Eur Heart J. 2015;36(1328):1334.

    Google Scholar 

  9. Malina M, Veith F, Ivancev K, Sonesson B. Balloon occlusion of the aorta during endovascular repair of ruptured abdominal aortic aneurysm. J Endovasc Ther. 2005;12:556–9.

    Google Scholar 

  10. Mayer D, Pfammatter T, Rancic Z, Hechelhammer L, Wilhelm M, Veith FJ, Lachat M. et al.. 10 years of emergency endovascular aneurysm repair for ruptured aortoiliac aneurysms: lessons learned. Ann Surg. 2009;249(3):510–5.

    Google Scholar 

  11. Mayer D, Rancic Z, Meier C, Pfammatter T, Veith FJ, Lachat M. Open abdomen treatment following endovascular repair of ruptured abdominal aortic aneurysms. J Vasc Surg. 2009;50(1):7.

    Google Scholar 

  12. Powell JT, Hinchliffe RJ, Thompson MM, Sweeting MJ, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve RJ, Heatley F, Thompson SG, Ulug P. Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm. Br J Surg. 2014;101(3):216–24; discussion 224.

    Google Scholar 

  13. Reimerink JJ, Hoornweg LL, Vahl AC, Wisselink W, van den Broek TA, Legemate DA, Reekers JA, Balm R. Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial. Ann Surg. 2013;258(2):248–56.

    Article  PubMed  Google Scholar 

  14. Richard Grieve MG, Sweeting MJ, Ulug P, Hinchliffe RJ, Thompson MM, Thompson SG, Ashleigh R, Greenhalgh RM, Powell JT. Endovascular strategy or open repair for ruptured abdominal aortic aneurysm: one-year outcomes from the IMPROVE randomized trial. Eur Heart J. 2015;36(31):2061–9.

    Google Scholar 

  15. Sweeting MJ, Balm R, Desgranges P, Ulug P, Powell JT, Ruptured Aneurysm T. Individual-patient meta-analysis of three randomized trials comparing endovascular versus open repair for ruptured abdominal aortic aneurysm. Br J Surg. 2015;102(10):1229–39.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  16. Veith FJ, Powell JT, Hinchliffe RJ. Is a randomized trial necessary to determine whether endovascular repair is the preferred management strategy in patients with ruptured abdominal aortic aneurysms? J Vasc Surg. 2010;52(4):1087–93.

    Article  PubMed  Google Scholar 

  17. Yusuf SW, Whitaker SC, Chuter TA, Wenham PW, Hopkinson BR. Emergency endovascular repair of leaking aortic aneurysm. Lancet. 1994;344(8397):1645.

    Google Scholar 

The Recent Randomized Trials of EVAR Versus Open Repair for Ruptured AAAs Are Misleading

  1. Veith FJ, Lachat M, Mayer D, Malina M, Holst J, Mehta M, Verhoeven EL, Larzon T, Gennai S, Coppi G, Lipsitz EC, Gargiulo NJ, van der Vliet JA, Blankensteijn J, Buth J, Lee WA, Biasi G, Deleo G, Kasirajan K, Moore R, Soong CV, Cayne NS, Farber MA, Raithel D, Greenberg RK, van Sambeek MR, Brunkwall JS, Rockman CB, Hinchliffe RJ, RAAA Investigators. Collected world and single center experience with endovascular treatment of ruptured abdominal aortic aneurysms. Ann Surg. 2009;250:818–24.

    Article  PubMed  Google Scholar 

  2. Von Allman RS, Schmidli J, Dick F. Regarding endovascular vs open repair for ruptured abdominal aortic aneurysm. J Vasc Surg. 2013;57:897.

    Article  Google Scholar 

  3. Saqib N, Park SC, Park T, Rhee RY, Chaer RA, Makaroun MS, Cho JS. Endovascular repair of ruptured abdominal aortic aneurysm does not confer survival benefits over open repair. J Vasc Surg. 2012;56:614–9.

    Article  PubMed  Google Scholar 

  4. Reimerink JJ, et al. Endovascular repair versus open repair of ruptured abdominal aortic aneurysms: a multicenter randomized controlled trial. Ann Surg. 2013;258:248–56.

    Article  PubMed  Google Scholar 

  5. Desgranges P, KobeiterH, Katsahian S, Bouffi M, Gouny P, Favre JP, Alsac JM, et al for the ECAR Investigators. A french randomized controlled trial of endovascular versus open surgical repair of ruptured aorto-iliac aneurysms. Eur J Vasc Endovasc Surg. 2015;50:303–10.

    Google Scholar 

  6. IMPROVE trial Investigtors, Powell JT, Sweeting MJ, Thompson MM, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve R, Heatley F, Hinchliffe RJ, Thompson SG, Ulug P. Endovascular or open repair strategy for ruptured abdominal aortic aneurysm: 30 day outcomes from IMPROVE randomised trial. BMJ. 2014;348:f7661.

    Article  Google Scholar 

  7. Berland TL, Veith FJ, Cayne NS, Mehta M, Mayer D, Lachat M. Technique of supraceliac balloon control of the aorta during endovascular repair of ruptured abdominal aortic aneurysms. J Vasc Surg. 2013;57:272–5.

    Article  PubMed  Google Scholar 

  8. Mayer D, Rancic Z, Meier C, Pfammatter T, Veith FJ, Lachat M. Open abdomen treatment following endovascular repair of ruptured abdominal aortic aneurysms. J Vasc Surg. 2009;50:1–7.

    Article  PubMed  Google Scholar 

  9. IMPROVE Trial Investigators, Powell JT, Thompson SG, Thompson MM, Grieve R, Nicholson AA, Ashleigh R, Hassan T, Moore F, Walker A, Braithwaite BD, Hinchliffe RJ, Greenhalgh RM, Cheshire NJ, Howell SJ, Soong CV. The immediate management of the patient with rupture: open versus endovascular repair (IMPROVE) aneurysm trial–ISRCTN 48334791 IMPROVE trialists. Acta Chir Belg. 2009;109:678–80.

    Article  Google Scholar 

  10. IMPROVE trial investigators, Powell JT, Hinchliffe RJ, Thompson MM, Sweeting MJ, Ashleigh R, Bell R, Gomes M, Greenhalgh RM, Grieve RJ, Heatley F, Thompson SG, Ulug P. Observations from the IMPROVE trial concerning the clinical care of patients with ruptured abdominal aortic aneurysm. Br J Surg. 2014;101:216–24.

    Article  PubMed Central  Google Scholar 

  11. IMPROVE Trial Investigators. An endovascular strategy for suspected ruptured abdominal aortic aneurysm brings earlier home discharge but not early survival or cost benefits. Eur J Vasc Endovasc Surg. 2014;47:333–4.

    Article  Google Scholar 

  12. IMPROVE Trial 30-day results: no difference between endovascular and open repair for ruptured aneurysms. Vascular News Issue 61, January 2014, Biba Medical, p. 1–2.

    Google Scholar 

  13. Mayer D, Aeschbacher S, Pfammatter T, Veith FJ, Norgren L, Magnuson A, Rancic Z, Lachat M, Hörer T, Skoog P, Larzon T. Complete replacement of open repair for ruptured abdominal aortic aneurysms by endovascular aneurysm repair: a two-center 14-year experience. Ann Surg. 2012;256:688–96.

    Article  CAS  PubMed  Google Scholar 

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Correspondence to Matt M. Thompson MD , Matt Thompson or Frank J. Veith and MD .

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Budge, J., Patterson, B., Thompson, M.M., Veith, F.J., Rockman, C.B. (2017). Randomized Trials: What is the Evidence?. In: Starnes, B., Mehta, M., Veith, F. (eds) Ruptured Abdominal Aortic Aneurysm. Springer, Cham. https://doi.org/10.1007/978-3-319-23844-9_14

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  • DOI: https://doi.org/10.1007/978-3-319-23844-9_14

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