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J Vasc Surg. 2011 May;53(5):1167-1173.e1. doi: 10.1016/j.jvs.2010.10.124. Epub 2011 Jan 26.

A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients.

Collaborators (136)

Becquemin JP, Sapoval M, Becquemin JP, Favre JP, Watelet J, Lermusiaux P, Sapoval M, Lepage E, Hemery F, Dolbeau G, Hawajry N, Cunin P, Harris P, Stockx L, Chatellier G, Mialhe C, Fiessinger JN, Pagny L, Kobeiter H, Boissier C, Lacroix P, Ledru F, Pinot Jean JJ, Deux F, Tzvetkov B, Duvaldestin P, Watelet J, Jourdain C, David V, Enouf D, Ady N, Krimi A, Boudjema N, Jousset Y, Enon B, Blin V, Picquet J, L'Hoste P, Thouveny F, Borie H, Kowarski S, Pernes JM, Auguste M, Becquemin JP, Desgranges P, Allaire E, Marzelle J, Kobeiter H, Meaulle PY, Chaix D, Juliae P, Fabiani JN, Chevalier P, Combes M, Seguin A, Belhomme D, Sapoval M, Baque J, Pellerin O, Favre JP, Barral X, Veyret C, Watelet J, Peillon C, Plissonier D, Thomas P, Clavier E, Lermusiaux P, Martinez R, Bleuet F, Verhoye JP, Langanay T, Heautot JF, Koussa M, Haulon S, Halna P, Destrieux L, Lions C, Wiloteaux S, Beregi JP, Bergeron P, Pinot JJ, Patra P, Costargent A, Chaillou P, D'Alicourt A, Goueffic Y, Cheysson E, Parrot A, Garance P, Abada I, Demon A, Tyazi A, Pillet JC, Lescalie F, Tilly G, Steinmetz E, Favier C, Brenot R, Krause D, Cercueil JP, Vahdat O, Sauer M, Soula P, Querian A, Garcia O, Levade M, Colombier D, Cardon JM, Joyeux A, Borrelly P, Dogas G, Magnan PÉ, Branchereau A, Bartoli JM, Hassen-Khodja R, Batt M, Planchard PF, Bouillanne PJ, Haudebourg P, Bayne J, Gouny P, Badra A, Braesco J, Nonent M, Lucas A, Cardon A, Kerdiles Y, Rolland Y, Kassab M, Brillu C, Goubault F, Tailboux L, Darrieux H, Briand O, Maillard JC.

Author information

1
Department of Vascular Surgery, Hopital Henri Mondor, University Paris XII, Creteil, France. jpbecquemin@hotmail.com

Abstract

BACKGROUND:

Several studies, including three randomized controlled trials (RCTs), have shown that endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) offered better early results than open surgical repair (OSR) but a similar medium-term to long-term mortality and a higher incidence of reinterventions. Thus, the role of EVAR, most notably in low-risk patients, remains debated.

METHODS:

The ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) trial compared mortality and major adverse events after EVAR and OSR in patients with AAA anatomically suitable for EVAR and at low-risk or intermediate-risk for open surgery. A total of 316 patients with >5 cm aneurysms were randomized in institutions with proven expertise for both treatments: 299 patients were available for analysis, and 149 were assigned to OSR and 150 to EVAR. Patients were monitored for 5 years after treatment. Statistical analysis was by intention to treat.

RESULTS:

With a median follow-up of 3 years (range, 0-4.8 years), there was no difference in the cumulative survival free of death or major events rates between OSR and EVAR: 95.9% ± 1.6% vs 93.2% ± 2.1% at 1 year and 85.1% ± 4.5% vs 82.4% ± 3.7% at 3 years, respectively (P = .09). In-hospital mortality (0.6% vs 1.3%; P = 1.0), survival, and the percentage of minor complications were not statistically different. In the EVAR group, however, the crude percentage of reintervention was higher (2.4% vs 16%, P < .0001), with a trend toward a higher aneurysm-related mortality (0.7% vs 4%; P = .12).

CONCLUSIONS:

In patients with low to intermediate risk factors, open repair of AAA is as safe as EVAR and remains a more durable option.

TRIAL REGISTRATION:

ClinicalTrials.gov NCT00224718.

PMID:
21276681
DOI:
10.1016/j.jvs.2010.10.124
[Indexed for MEDLINE]
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