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

Jean-Pierre Becquemin, Jean-Chistophe Pillet, François Lescalie, Marc Sapoval, Yann Goueffic, Patrick Lermusiaux, Eric Steinmetz, Jean Marzelle, ACE trialists, Jean-Pierre Becquemin, Marc Sapoval, Jean-Pierre Becquemin, Jean-Pierre Favre, Jacques Watelet, Patrick Lermusiaux, Marc Sapoval, Eric Lepage, François Hemery, Guillaume Dolbeau, Nasser Hawajry, Patric Cunin, Peter Harris, Luc Stockx, Gilles Chatellier, Claude Mialhe, Jean-Noel Fiessinger, Luc Pagny, Hicham Kobeiter, Christian Boissier, Philippe Lacroix, François Ledru, Jean-Jacques Pinot Jean, François Deux, Boyan Tzvetkov, Philippe Duvaldestin, Jacques Watelet, Cécile Jourdain, Virginie David, Delphine Enouf, Namou Ady, Amor Krimi, Noël Boudjema, Yann Jousset, Bernard Enon, Vincent Blin, Jean Picquet, Philippe L'Hoste, Francine Thouveny, Hervé Borie, Stéphane Kowarski, Jean-Marc Pernes, Mario Auguste, Jean-Pierre Becquemin, Pascal Desgranges, Eric Allaire, Jean Marzelle, Hicham Kobeiter, Pierre-Yves Meaulle, Dominique Chaix, Pierre Juliae, Jean Noël Fabiani, Patrick Chevalier, Myriam Combes, Agathe Seguin, Denis Belhomme, Marc Sapoval, Jean Baque, Olivier Pellerin, Jean Pierre Favre, Xavier Barral, Charles Veyret, Jacques Watelet, Christophe Peillon, Didier Plissonier, Pascale Thomas, Eric Clavier, Patrick Lermusiaux, Robert Martinez, François Bleuet, Jean Philippe Verhoye, Thierry Langanay, Jean François Heautot, Mohamad Koussa, Stephan Haulon, Pascal Halna, Laurence Destrieux, Christophe Lions, Serge Wiloteaux, Jean Paul Beregi, Patrice Bergeron, Jean-Jacques Pinot, Philippe Patra, Alain Costargent, Philippe Chaillou, Aline D'Alicourt, Yann Goueffic, Eric Cheysson, Alain Parrot, Patrick Garance, Icham Abada, Arnaud Demon, Abdelhakim Tyazi, Jean-Christophe Pillet, François Lescalie, Gérard Tilly, Eric Steinmetz, Claire Favier, Roger Brenot, Denis Krause, Jean Pierre Cercueil, Olivier Vahdat, Michel Sauer, Philippe Soula, Aristide Querian, Olivier Garcia, Michel Levade, Daniel Colombier, Jean-Marie Cardon, André Joyeux, Pierre Borrelly, Georges Dogas, Pierre-Édouard Magnan, Alain Branchereau, Jean-Michel Bartoli, Réda Hassen-Khodja, Michel Batt, Pierre-Franck Planchard, Pierre-Jean Bouillanne, Pierre Haudebourg, Jean Bayne, Pierre Gouny, Ali Badra, Jacques Braesco, Michel Nonent, Antoine Lucas, Alain Cardon, Yvon Kerdiles, Yann Rolland, Michael Kassab, Christophe Brillu, François Goubault, Laurent Tailboux, Hugues Darrieux, Olivier Briand, Jean-Claude Maillard, Jean-Pierre Becquemin, Jean-Chistophe Pillet, François Lescalie, Marc Sapoval, Yann Goueffic, Patrick Lermusiaux, Eric Steinmetz, Jean Marzelle, ACE trialists, Jean-Pierre Becquemin, Marc Sapoval, Jean-Pierre Becquemin, Jean-Pierre Favre, Jacques Watelet, Patrick Lermusiaux, Marc Sapoval, Eric Lepage, François Hemery, Guillaume Dolbeau, Nasser Hawajry, Patric Cunin, Peter Harris, Luc Stockx, Gilles Chatellier, Claude Mialhe, Jean-Noel Fiessinger, Luc Pagny, Hicham Kobeiter, Christian Boissier, Philippe Lacroix, François Ledru, Jean-Jacques Pinot Jean, François Deux, Boyan Tzvetkov, Philippe Duvaldestin, Jacques Watelet, Cécile Jourdain, Virginie David, Delphine Enouf, Namou Ady, Amor Krimi, Noël Boudjema, Yann Jousset, Bernard Enon, Vincent Blin, Jean Picquet, Philippe L'Hoste, Francine Thouveny, Hervé Borie, Stéphane Kowarski, Jean-Marc Pernes, Mario Auguste, Jean-Pierre Becquemin, Pascal Desgranges, Eric Allaire, Jean Marzelle, Hicham Kobeiter, Pierre-Yves Meaulle, Dominique Chaix, Pierre Juliae, Jean Noël Fabiani, Patrick Chevalier, Myriam Combes, Agathe Seguin, Denis Belhomme, Marc Sapoval, Jean Baque, Olivier Pellerin, Jean Pierre Favre, Xavier Barral, Charles Veyret, Jacques Watelet, Christophe Peillon, Didier Plissonier, Pascale Thomas, Eric Clavier, Patrick Lermusiaux, Robert Martinez, François Bleuet, Jean Philippe Verhoye, Thierry Langanay, Jean François Heautot, Mohamad Koussa, Stephan Haulon, Pascal Halna, Laurence Destrieux, Christophe Lions, Serge Wiloteaux, Jean Paul Beregi, Patrice Bergeron, Jean-Jacques Pinot, Philippe Patra, Alain Costargent, Philippe Chaillou, Aline D'Alicourt, Yann Goueffic, Eric Cheysson, Alain Parrot, Patrick Garance, Icham Abada, Arnaud Demon, Abdelhakim Tyazi, Jean-Christophe Pillet, François Lescalie, Gérard Tilly, Eric Steinmetz, Claire Favier, Roger Brenot, Denis Krause, Jean Pierre Cercueil, Olivier Vahdat, Michel Sauer, Philippe Soula, Aristide Querian, Olivier Garcia, Michel Levade, Daniel Colombier, Jean-Marie Cardon, André Joyeux, Pierre Borrelly, Georges Dogas, Pierre-Édouard Magnan, Alain Branchereau, Jean-Michel Bartoli, Réda Hassen-Khodja, Michel Batt, Pierre-Franck Planchard, Pierre-Jean Bouillanne, Pierre Haudebourg, Jean Bayne, Pierre Gouny, Ali Badra, Jacques Braesco, Michel Nonent, Antoine Lucas, Alain Cardon, Yvon Kerdiles, Yann Rolland, Michael Kassab, Christophe Brillu, François Goubault, Laurent Tailboux, Hugues Darrieux, Olivier Briand, Jean-Claude Maillard

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.

Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

Source: PubMed

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