Meta-analysis of individual-patient data from EVAR-1, DREAM, OVER and ACE trials comparing outcomes of endovascular or open repair for abdominal aortic aneurysm over 5 years
Author:
Powell J T1, Sweeting M J2, Ulug P1, Blankensteijn J D3, Lederle F A4, Becquemin J-P5, Greenhalgh R M1, Greenhalgh R M, Beard J D, Buxton M J, Brown L C, Harris P L, Powell J T, Rose J D G, Russell I T, Sculpher M J, Thompson S G, Lilford R J, Bell P R F, Greenhalgh R M, Whitaker S C, Poole-Wilson P A, Ruckley C V, Campbell W B, Dean M R E, Ruttley M S T, Coles E C, Powell J T, Halliday A, Gibbs S J, Brown L C, Epstein D, Sculpher M J, Thompson S G, Hannon R J6, Johnston L6, Bradbury A W7, Henderson M J7, Parvin S D8, Shepherd D F C8, Greenhalgh R M9, Mitchell A W9, Edwards P R10, Abbott G T10, Higman D J11, Vohra A11, Ashley S12, Robottom C12, Wyatt M G13, Rose J D G13, Byrne D14, Edwards R14, Leiberman D P15, McCarter D H15, Taylor P R16, Reidy J F16, Wilkinson A R17, Ettles D F17, Clason A E18, Leen G L S18, Wilson N V19, Downes M19, Walker S R20, Lavelle J M20, Gough M J21, McPherson S21, Scott D J A22, Kessell D O22, Naylor R23, Sayers R23, Fishwick N G23, Harris P L24, Gould D A24, Walker M G25, Chalmers N C25, Garnham A26, Collins M A26, Beard J D27, Gaines P A27, Ashour M Y28, Uberoi R28, Braithwaite B29, Whitaker S C29, Davies J N30, Travis S30, Hamilton G31, Platts A31, Shandall A32, Sullivan B A32, Sobeh M33, Matson M33, Fox A D34, Orme R34, Yusef W35, Doyle T35, Horrocks M36, Hardman J36, Blair P H B37, Ellis P K37, Morris G38, Odurny A38, Vohra R39, Duddy M39, Thompson M40, Loosemore T M L40, Belli A M40, Morgan R40, Adiseshiah M41, Brookes J A S41, McCollum C N42, Ashleigh R42, Aukett M, Baker S, Barbe E, Batson N, Bell J, Blundell J, Boardley D, Boyes S, Brown O, Bryce J, Carmichael M, Chance T, Coleman J, Cosgrove C, Curran G, Dennison T, Devine C, Dewhirst N, Errington B, Farrell H, Fisher C, Fulford P, Gough M, Graham C, Hooper R, Horne G, Horrocks L, Hughes B, Hutchings T, Ireland M, Judge C, Kelly L, Kemp J, Kite A, Kivela M, Lapworth M, Lee C, Linekar L, Mahmood A, March L, Martin J, Matharu N, McGuigen K, Morris-Vincent P, Murray S, Murtagh A, Owen G, Ramoutar V, Rippin C, Rowley J, Sinclair J, Spencer S, Taylor V, Tomlinson C, Ward S, Wealleans V, West J, White K, Williams J, Wilson L, Grobbee D E, Blankensteijn J D, Bak A A A, Buth J, Pattynama P M, Verhoeven E L G, van Voorthuisen A E, Blankensteijn J D, Balm R, Buth J, Cuypers P W M, Grobbee D E, Prinssen M, van Sambeek M R H M, Verhoeven E L G, Baas A F, Hunink M G, van Engelshoven J M, Jacobs M J H M, de Mol B A J M, van Bockel J H, Balm R, Reekers J, Tielbeek X, Verhoeven E L G, Wisselink W, Boekema N, Heuveling L M, Sikking I, Prinssen M, Balm R, Blankensteijn J D, Buth J, Cuypers P W M, van Sambeek M R H M, Verhoeven E L G, de Bruin J L, Baas A F, Blankensteijn J D, Prinssen M, Buskens E, Buth J43, Tielbeek A V43, Blankensteijn J D44, Balm R45, Reekers J A45, van Sambeek M R H M46, Pattynama P46, Verhoeven E L G47, Prins T47, van der Ham A C48, van der Velden J J I M48, van Sterkenburg S M M49, ten Haken G B49, Bruijninckx C M A50, van Overhagen H50, Tutein Nolthenius R P51, Hendriksz T R51, Teijink J A W52, Odink H F52, de Smet A A E A53, Vroegindeweij D53, van Loenhout R M M54, Rutten M J54, Hamming J F55, Lampmann L E H55, Bender M H M56, Pasmans H56, Vahl A C57, de Vries C57, Mackaay A J C58, van Dortmont L M C59, van der Vliet A J60, Schultze Kool L J60, Boomsma J H B61, van Dop H R61, de Mol van Otterloo J C A62, de Rooij T P W62, Smits T M63, Yilmaz E N64, Wisselink W65, van den Berg F G65, Visser M J T66, van der Linden E66, Schurink G W H67, de Haan M67, Smeets H J68, Stabel P69, van Elst F70, Poniewierski J71, Vermassen F E G72, Lederle F A73, Freischlag J A73, Kohler T R73, Latts E73, Matsumura J73, Padberg F T73, Kyriakides T C73, Swanson K M73, Guarino P74, Peduzzi P74, Antonelli M74, Cushing C74, Davis E74, Durant L74, Joyner S74, Kossack A74, Kyriakides T C74, LeGwin Mary74, McBride V74, O'Connor T74, Poulton J74, Stratton S74, Zellner S74, Snodgrass A J75, Thornton J75, Swanson K M75, Haakenson C M76, Stroupe K T77, Jonk Y78, Hallett J W79, Hertzer N79, Towne J79, Katz D A79, Karrison T79, Matts J P79, Marottoli R80, Kasl S80, Mehta R80, Feldman R80, Farrell W80, Allore H80, Perry E80, Niederman J80, Randall F80, Zeman M80, Beckwith D80, O'Leary T J81, Huang G D82, Latts E, Bader M, Ketteler E R83, Kingsley D D83, Marek J M83, Massen R J83, Matteson B D83, Pitcher J D83, Langsfeld M83, Corson J D83, Goff J M83, Kasirajan K83, Paap C83, Robertson D C83, Salam A84, Veeraswamy R84, Milner R84, Kasirajan K84, Guidot J84, Lal B K85, Busuttil S J85, Lilly M P85, Braganza M85, Ellis K85, Patterson M A86, Jordan W D86, Whitley D86, Taylor S86, Passman M86, Kerns D86, Inman C86, Poirier J86, Ebaugh J87, Raffetto J87, Chew D87, Lathi S87, Owens C87, Hickson K87, Dosluoglu H H88, Eschberger K88, Kibbe M R89, Baraniewski H M89, Matsumura J89, Endo M89, Busman A89, Meadows W89, Evans M89, Giglia J S90, El Sayed H90, Reed A B90, Ruf M90, Ross S90, Jean-Claude J M91, Pinault G91, Kang P91, White N91, Eiseman M91, Jones R91, Timaran C H92, Modrall J G92, Welborn M B92, Lopez J92, Nguyen T92, Chacko J K Y93, Granke K93, Vouyouka A G93, Olgren E93, Chand P93, Allende B93, Ranella M93, Yales C93, Whitehill T A94, Krupski W C94, Nehler M R94, Johnson S P94, Jones D N94, Strecker P94, Bhola M A94, Shortell C K95, Gray J L95, Lawson J H95, McCann R95, Sebastian M W95, Kistler Tetterton J95, Blackwell C95, Prinzo P A95, Lee N95, Padberg F T96, Cerveira J J96, Lal B K96, Zickler R W96, Hauck K A96, Berceli S A97, Lee W A97, Ozaki C K97, Nelson P R97, Irwin A S97, Baum R, Aulivola B98, Rodriguez H98, Littooy F N98, Greisler H98, O'Sullivan M T, Kougias P99, Lin P H99, Bush R L99, Guinn G99, Bechara C99, Cagiannos C99, Pisimisis G99, Barshes N99, Pillack S99, Guillory B99, Cikrit D100, Lalka S G100, Lemmon G100, Nachreiner R100, Rusomaroff M100, O'Brien E, Cullen J J101, Hoballah J101, Sharp W J101, McCandless J L101, Beach V, Minion D102, Schwarcz T H102, Kimbrough J102, Ashe L102, Rockich A102, Warner-Carpenter J102, Moursi M103, Eidt J F103, Brock S103, Bianchi C104, Bishop V104, Gordon I L105, Fujitani R105, Kubaska S M105, Behdad M105, Azadegan R105, Ma Agas C105, Zalecki K105, Hoch J R106, Carr S C106, Acher C106, Schwarze M106, Tefera G106, Mell M106, Dunlap B106, Rieder J106, Stuart J M107, Weiman D S107, Abul-Khoudoud O107, Garrett H E107, Walsh S M107, Wilson K L107, Seabrook G R108, Cambria R A108, Brown K R108, Lewis B D108, Framberg S108, Kallio C108, Barke R A109, Santilli S M109, d'Audiffret A C109, Oberle N109, Proebstle C109, Johnson L L109, Jacobowitz G R110, Cayne N110, Rockman C110, Adelman M110, Gagne P110, Nalbandian M110, Caropolo L J110, Pipinos I I111, Johanning J111, Lynch T111, DeSpiegelaere H111, Purviance G111, Zhou W112, Dalman R112, Lee J T112, Safadi B112, Coogan S M112, Wren S M112, Bahmani D D112, Maples D112, Thunen S112, Golden M A113, Mitchell M E113, Fairman R113, Reinhardt S113, Wilson M A114, Tzeng E114, Muluk S114, Peterson N M114, Foster M114, Edwards J115, Moneta G L115, Landry G115, Taylor L115, Yeager R115, Cannady E115, Treiman G116, Hatton-Ward S116, Salabsky B116, Kansal N117, Owens E, Estes M117, Forbes B A117, Sobotta C117, Rapp J H118, Reilly L M118, Perez S L118, Yan K118, Sarkar R118, Dwyer S S118, Perez S118, Chong K118, Kohler T R119, Hatsukami T S119, Glickerman D G119, Sobel M119, Burdick T S119, Pedersen K119, Cleary P119, Back M120, Bandyk D120, Johnson B120, Shames M120, Reinhard R L120, Thomas S C120, Hunter G C121, Leon L R121, Westerband A121, Guerra R J121, Riveros M121, Mills J L121, Hughes J D121, Escalante A M121, Psalms S B121, Day N N121, Macsata R122, Sidawy A122, Weiswasser J122, Arora S122, Jasper B J122, Dardik A123, Gahtan V123, Muhs B E123, Sumpio B E123, Gusberg R J123, Spector M123, Pollak J123, Aruny J123, Kelly E L123, Wong J123, Vasilas P123, Joncas C123, Gelabert H A124, DeVirgillio C124, Rigberg D A124, Cole L124, Becquemin J-P, Marzelle J, Becquemin J-P, Sapoval M, Becquemin J-P, Favre J-P, 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 J-N, Pagny L, Kobeiter H, Boissier C, Lacroix P, Ledru F, Pinot J-J, Deux J-F, Tzvetkov B, Duvaldestin P, Watelet J, Jourdain C, David V, Enouf D, Ady N, Krimi A, Boudjema N, Jousset Y125, Enon B125, Blin V125, Picquet J125, L'Hoste P125, Thouveny F125, Borie H126, Kowarski S126, Pernes J-M126, Auguste M126, Becquemin J-P127, Desgranges P127, Allaire E127, Marzelle J127, Kobeiter H127, Meaulle P-Y128, Chaix D128, Juliae P129, Fabiani J N129, Chevalier P129, Combes M129, Seguin A129, Belhomme D129, Sapoval M129, Baque J129, Pellerin O129, Favre J P130, Barral X130, Veyret C130, Watelet J131, Peillon C131, Plissonier D131, Thomas P131, Clavier E131, Lermusiaux P132, Martinez R132, Bleuet F132, C Dupreix132, Verhoye J P133, Langanay T133, Heautot J F133, Koussa M134, Haulon S134, Halna P134, Destrieux L134, Lions C134, Wiloteaux S134, Beregi J P134, Bergeron P135, Pinot J-J135, Patra P136, Costargent A136, Chaillou P136, D'Alicourt A136, Goueffic Y136, Cheysson E137, Parrot A137, Garance P137, Demon A138, Tyazi A138, Pillet J-C139, Lescalie F140, Tilly G140, Steinmetz E141, Favier C141, Brenot R141, Krause D141, Cercueil J P141, Vahdat O142, Sauer M142, Soula P142, Querian A142, Garcia O142, Levade M142, Colombier D142, Cardon J-M143, Joyeux A143, Borrelly P143, Dogas G143, Magnan P-É144, Branchereau A144, Bartoli J-M144, Hassen-Khodja R145, Batt M145, Planchard P-F145, Bouillanne P-J145, Haudebourg P145, Bayne J145, Gouny P146, Badra A146, Braesco J146, Nonent M146, Lucas A147, Cardon A147, Kerdiles Y147, Rolland Y147, Kassab M148, Brillu C148, Goubault F148, Tailboux L148, Darrieux H149, Briand O149, Maillard J-C149, Varty K150, Cousins C150
Affiliation:
1. Vascular Surgery Research Group, Imperial College London, London, UK 2. Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK 3. Department of Surgery, VU Medical Centre, Amsterdam, The Netherlands 4. Department of Medicine, VA Medical Centre, Minneapolis, Minnesota, USA 5. Vascular Institute of Paris East, Hôpital Privé Paul d'Egine, Champigny, Université, Paris-Est Créteil, Créteil, France 6. Belfast City Hospital, Belfast, 53 7. Birmingham Heartlands Hospital, Birmingham, 8 8. Bournemouth General Hospital, Bournemouth, 68 9. Charing Cross Hospital, London, 27 10. Countess of Chester Hospital, Chester, 15 11. Coventry and Walsgrave Hospital, Coventry, 8 12. Derriford Hospital, Plymouth, 2 13. Freeman Hospital, Newcastle upon Tyne, 121 14. Gartnavel General Hospital, Glasgow, 12 15. Glasgow Royal Infirmary, Glasgow, 19 16. Guy's and St Thomas’ Hospital, London, 124 17. Hull Royal Infirmary, Hull, 29 18. James Cook University Hospital, Middlesborough, 19 19. Kent and Canterbury Hospital, Canterbury, 1 20. Lancaster General Infirmary, Lancaster, 12 21. Leeds General Infirmary, Leeds, 38 22. Leeds St James's Hospital, Leeds, 11 23. Leicester Royal Infirmary, Leicester, 148 24. Liverpool Royal Hospital, Liverpool, 143 25. Manchester Royal Infirmary, Manchester, 96 26. New Cross Hospital, Wolverhampton, 1 27. Northern General Hospital, Sheffield, 77 28. Queen Elizabeth Hospital, Gateshead, 18 29. Queen's Medical Centre, Nottingham, 116 30. Royal Cornwall Hospital, Truro, 26 31. Royal Free Hospital, London, 42 32. Royal Gwent Hospital, Newport, 1 33. Royal London Hospital, London, 7 34. Royal Shrewsbury Hospital, Shrewsbury, 7 35. Royal Sussex County Hospital, Brighton, 6 36. Royal United Hospital, Bath, 34 37. Royal Victoria Hospital, Belfast, 46 38. Southampton General Hospital, Southampton, 39 39. Selly Oak Hospital, Birmingham, 22 40. St George's Hospital, London, 54 41. University College Hospital, London, 69 42. University Hospital of South Manchester, Manchester, 127 43. Catharina Hospital, Eindhoven, 94 44. University Medical Centre, Utrecht, 35 45. Academic Medical Centre, Amsterdam, 32 46. Erasmus Medical Centre, Rotterdam, 30 47. University Hospital, Groningen, 27 48. St Franciscus Gasthuis, Rotterdam, 27 49. Rijnstate Hospital, Arnhem, 14 50. Leyenburg Hospital, ‘s-Gravenhage, 9 51. Albert Schweitzer Hospital, Dordrecht, 8 52. Atrium Medical Centre, Heerlen, 8 53. Medical Centre Rijnmond Zuid, Rotterdam, 7 54. Jeroen Bosch Hospital, den Bosch, 7 55. St Elisabeth Hospital, Tilburg, 5 56. Maxima Medical Centre, Veldhoven, 5 57. Onze Lieve Vrouwe Gasthuis, Amsterdam, 5 58. Meander Medical Centre, Amersfoort, 4 59. Vlietland Hospital, Schiedam, 4 60. University Medical Centre, Nijmegen, 4 61. Martini Hospital, Groningen, 3 62. Medical Centre Haaglanden, ‘s-Gravenhage, 3 63. Hospital Bernhoven, Oss 64. Oosterschelde Hospital, Goes, 3 65. Vrije Universiteit Medical Centre, Amsterdam, 2 66. Leiden University Medical Centre, Leiden, 1 67. University Medical Centre, Maastricht, 1 68. Bronovo Hospital, ‘s-Gravenhage, 1, Belgium 69. St Jozef Hospital, Turnhout, 4 70. St Trudo Hospital, St Truiden, 3 71. University Hospital, Antwerp, 1 72. University Medical Centre, Ghent, 1 73. Cooperative Studies Program Coordinating Center VA Connecticut Healthcare System, West Haven, Connecticut 74. Regulatory Affairs and Clinical Compliance Section, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center 75. VA Research Site Management and Review Team (SMART) 76. Center for Management of Complex Care, Veterans Affairs Medical Center (VAMC), Hines, Illinois 77. Center for Chronic Disease Outcomes Research, VAMC, Minneapolis, Minnesota 78. Data and Safety Monitoring Board 79. Human Rights Committee West Haven, Connecticut 80. Central Administration, Cooperative Studies Program (VA Central Office) 81. Clinical Science Research and Development Service 82. National Project Coordinators, Minneapolis VAMC 83. Albuquerque, New Mexico 84. Atlanta, Georgia 85. Baltimore, Maryland 86. Birmingham, Alabama 87. Boston, Massachusetts 88. Buffalo, New York 89. Chicago, Illinois 90. Cincinnati, Ohio 91. Cleveland, Ohio 92. Dallas, Texas 93. Detroit, Michigan 94. Denver, Colorado 95. Durham, North Carolina 96. East Orange, New Jersey 97. Gainesville, Florida 98. Hines, Illinois 99. Houston, Texas 100. Indianapolis, Indiana 101. Iowa City, Iowa 102. Lexington, Kentucky 103. Little Rock, Arkansas 104. Loma Linda, California 105. Long Beach, California 106. Madison, Wisconsin 107. Memphis, Tennessee 108. Milwaukee, Wisconsin 109. Minneapolis, Minnesota 110. New York, New York 111. Omaha, Nebraska 112. Palo Alto, California 113. Philadelphia, Pennsylvania 114. Pittsburgh, Pennsylvania 115. Portland, Oregon 116. Salt Lake City, Utah 117. San Diego, California 118. San Francisco, California 119. Seattle, Washington 120. Tampa, Florida 121. Tucson, Arizona 122. Washington, DC 123. West Haven, Connecticut 124. West Los Angeles, California 125. Centre Hospitalier Universitaire (CHU) Angers–Hôtel Dieu, Angers, 3 126. Hôpital privé d'Antony, Antony, 5 127. Hôpital Henri Mondor, Creteil, 102 128. Clinique mutualiste des Eaux Claires, Grenoble, 1 129. Hôpital Européen Georges Pompidou, Paris, 3 130. CHU Nord, Saint Étienne, 14 131. Hôpital Charles Nicolle, Rouen, 9 132. Hôpital Trousseau, Tours, 17 133. CHU de Pontchaillou, Rennes, 2 134. Hôpital Cardiologique, Lille, 5 135. Hôpital Saint Joseph, Marseille, 11 136. Hôpital G et R Laennec, Nantes, 20 137. Icham Abada Centre Hospitalier René Dubos, Pontoise, 1 138. Centre Hospitalier de Valenciennes, Valenciennes, 4 139. Nouvelles Cliniques Nantaises, Nantes, 33 140. Clinique Saint-Augustin, Nantes, 25 141. Hôpital du Bocage, Dijon, 15 142. Clinique Pasteur, Toulouse, 2 143. Clinique des Franciscaines, Nimes, 10 144. Hôpital d'adultes de la Timone, Marseille, 1 145. Hôpital Saint Roch, Nice, 10 146. Hôpital La Cavale Blanche, Brest, 2 147. Hôpital Sud, Rennes, 3 148. Polyclinique de Poitiers, Poitiers, 2 149. Clinique Marie Immaculée, Bourges, 6 150. Addenbrookes Hospital, Cambridge, 10
Abstract
Abstract
Background
The erosion of the early mortality advantage of elective endovascular aneurysm repair (EVAR) compared with open repair of abdominal aortic aneurysm remains without a satisfactory explanation.
Methods
An individual-patient data meta-analysis of four multicentre randomized trials of EVARversus open repair was conducted to a prespecified analysis plan, reporting on mortality, aneurysm-related mortality and reintervention.
Results
The analysis included 2783 patients, with 14 245 person-years of follow-up (median 5·5 years). Early (0–6 months after randomization) mortality was lower in the EVAR groups (46 of 1393 versus 73 of 1390 deaths; pooled hazard ratio 0·61, 95 per cent c.i. 0·42 to 0·89; P = 0·010), primarily because 30-day operative mortality was lower in the EVAR groups (16 deaths versus 40 for open repair; pooled odds ratio 0·40, 95 per cent c.i. 0·22 to 0·74). Later (within 3 years) the survival curves converged, remaining converged to 8 years. Beyond 3 years, aneurysm-related mortality was significantly higher in the EVAR groups (19 deaths versus 3 for open repair; pooled hazard ratio 5·16, 1·49 to 17·89; P = 0·010). Patients with moderate renal dysfunction or previous coronary artery disease had no early survival advantage under EVAR. Those with peripheral artery disease had lower mortality under open repair (39 deaths versus 62 for EVAR; P = 0·022) in the period from 6 months to 4 years after randomization.
Conclusion
The early survival advantage in the EVAR group, and its subsequent erosion, were confirmed. Over 5 years, patients of marginal fitness had no early survival advantage from EVAR compared with open repair. Aneurysm-related mortality and patients with low ankle : brachial pressure index contributed to the erosion of the early survival advantage for the EVAR group. Trial registration numbers: EVAR-1, ISRCTN55703451; DREAM (Dutch Randomized Endovascular Aneurysm Management), NCT00421330; ACE (Anévrysme de l'aorte abdominale, Chirurgie versus Endoprothèse), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.
Funder
National Institute for Health Research Department of Health
Publisher
Oxford University Press (OUP)
Cited by
296 articles.
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