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

J. T. Powell; M. J. Sweeting; P. Ulug; J. D. Blankensteijn; F. A. Lederle; J. P. Becquemin; R. M. Greenhalgh; J. D. Beard; M. J. Buxton; L. C. Brown; P. L. Harris; J. D.G. Rose; I. T. Russell; M. J. Sculpher; S. G. Thompson; R. J. Lilford; P. R.F. Bell; S. C. Whitaker; P. A. Poole-Wilson; C. V. Ruckley; W. B. Campbell; M. R.E. Dean; M. S.T. Ruttley; E. C. Coles; A. Halliday; S. J. Gibbs; D. Epstein; R. J. Hannon; L. Johnston; A. W. Bradbury; M. J. Henderson; S. D. Parvin; D. F.C. Shepherd; A. W. Mitchell; P. R. Edwards; G. T. Abbott; D. J. Higman; A. Vohra; S. Ashley; C. Robottom; M. G. Wyatt; D. Byrne; R. Edwards; EVAR-1 trial; DREAM trial; OVER trial; ACE trial; Gerardus Schurink; Michiel de Haan

doi:10.1002/bjs.10430

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

J. T. Powell, M. J. Sweeting, P. Ulug, J. D. Blankensteijn, F. A. Lederle, J. P. Becquemin, R. M. Greenhalgh^*, J. D. Beard, M. J. Buxton, L. C. Brown, P. L. Harris, J. D.G. Rose, I. T. Russell, M. J. Sculpher, S. G. Thompson, R. J. Lilford, P. R.F. Bell, S. C. Whitaker, P. A. Poole-Wilson, C. V. RuckleyW. B. Campbell, M. R.E. Dean, M. S.T. Ruttley, E. C. Coles, A. Halliday, S. J. Gibbs, D. Epstein, R. J. Hannon, L. Johnston, A. W. Bradbury, M. J. Henderson, S. D. Parvin, D. F.C. Shepherd, A. W. Mitchell, P. R. Edwards, G. T. Abbott, D. J. Higman, A. Vohra, S. Ashley, C. Robottom, M. G. Wyatt, D. Byrne, R. Edwards, EVAR-1 trial, DREAM trial, OVER trial, ACE trial, Gerardus Schurink, Michiel de Haan

^*Corresponding author for this work

Research output: Contribution to journal › (Systematic) Review article › peer-review

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 EVAR versus 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.

Original language	English
Pages (from-to)	166-178
Number of pages	13
Journal	British Journal of Surgery
Volume	104
Issue number	3
DOIs	https://doi.org/10.1002/bjs.10430
Publication status	Published - 1 Feb 2017

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Powell, J. T., Sweeting, M. J., Ulug, P., Blankensteijn, J. D., Lederle, F. A., Becquemin, J. P., Greenhalgh, R. M., Beard, J. D., Buxton, M. J., Brown, L. C., Harris, P. L., Rose, J. D. G., Russell, I. T., Sculpher, M. J., Thompson, S. G., Lilford, R. J., Bell, P. R. F., Whitaker, S. C., Poole-Wilson, P. A., ... de Haan, M. (2017). 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. British Journal of Surgery, 104(3), 166-178. https://doi.org/10.1002/bjs.10430

@article{ccbb35c3daf141578a525fce52de0fe5,

title = "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",

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 EVAR versus 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 (An{\'e}vrysme de l'aorte abdominale, Chirurgie versus Endoproth{\`e}se), NCT00224718; OVER (Open Versus Endovascular Repair Trial for Abdominal Aortic Aneurysms), NCT00094575.",

author = "Powell, {J. T.} and Sweeting, {M. J.} and P. Ulug and Blankensteijn, {J. D.} and Lederle, {F. A.} and Becquemin, {J. P.} and Greenhalgh, {R. M.} and Beard, {J. D.} and Buxton, {M. J.} and Brown, {L. C.} and Harris, {P. L.} and Rose, {J. D.G.} and Russell, {I. T.} and Sculpher, {M. J.} and Thompson, {S. G.} and Lilford, {R. J.} and Bell, {P. R.F.} and Whitaker, {S. C.} and Poole-Wilson, {P. A.} and Ruckley, {C. V.} and Campbell, {W. B.} and Dean, {M. R.E.} and Ruttley, {M. S.T.} and Coles, {E. C.} and A. Halliday and Gibbs, {S. J.} and D. Epstein and Hannon, {R. J.} and L. Johnston and Bradbury, {A. W.} and Henderson, {M. J.} and Parvin, {S. D.} and Shepherd, {D. F.C.} and Mitchell, {A. W.} and Edwards, {P. R.} and Abbott, {G. T.} and Higman, {D. J.} and A. Vohra and S. Ashley and C. Robottom and Wyatt, {M. G.} and D. Byrne and R. Edwards and {EVAR-1 trial} and {DREAM trial} and {OVER trial} and {ACE trial} and Gerardus Schurink and {de Haan}, Michiel",

note = "Funding Information: The individual-patient data meta-analysis was funded by the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) project 11/36/46 as a contract variation (Chief Investigator R. Greenhalgh). There was some support from the Camelia Botnar Research Foundation. They had no role in the study design, in the collection, merging, analysis or reporting of data, in the writing of the report, or in the decision to submit the paper for publication. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA Programme, NIHR, National Health Service or the Department of Health. Disclosure: The authors declare no conflict of interest. Publisher Copyright: {\textcopyright} 2017 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.",

year = "2017",

month = feb,

day = "1",

doi = "10.1002/bjs.10430",

language = "English",

volume = "104",

pages = "166--178",

journal = "British Journal of Surgery",

issn = "0007-1323",

publisher = "Oxford University Press",

number = "3",

}

Powell, JT, Sweeting, MJ, Ulug, P, Blankensteijn, JD, Lederle, FA, Becquemin, JP, Greenhalgh, RM, Beard, JD, Buxton, MJ, Brown, LC, Harris, PL, Rose, JDG, Russell, IT, Sculpher, MJ, Thompson, SG, Lilford, RJ, Bell, PRF, Whitaker, SC, Poole-Wilson, PA, Ruckley, CV, Campbell, WB, Dean, MRE, Ruttley, MST, Coles, EC, Halliday, A, Gibbs, SJ, Epstein, D, Hannon, RJ, Johnston, L, Bradbury, AW, Henderson, MJ, Parvin, SD, Shepherd, DFC, Mitchell, AW, Edwards, PR, Abbott, GT, Higman, DJ, Vohra, A, Ashley, S, Robottom, C, Wyatt, MG, Byrne, D, Edwards, R, EVAR-1 trial, DREAM trial, OVER trial, ACE trial, Schurink, G & de Haan, M 2017, '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', British Journal of Surgery, vol. 104, no. 3, pp. 166-178. https://doi.org/10.1002/bjs.10430

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. / Powell, J. T.; Sweeting, M. J.; Ulug, P. et al.
In: British Journal of Surgery, Vol. 104, No. 3, 01.02.2017, p. 166-178.

Research output: Contribution to journal › (Systematic) Review article › peer-review

TY - JOUR

T1 - 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

AU - Powell, J. T.

AU - Sweeting, M. J.

AU - Ulug, P.

AU - Blankensteijn, J. D.

AU - Lederle, F. A.

AU - Becquemin, J. P.

AU - Greenhalgh, R. M.

AU - Beard, J. D.

AU - Buxton, M. J.

AU - Brown, L. C.

AU - Harris, P. L.

AU - Rose, J. D.G.

AU - Russell, I. T.

AU - Sculpher, M. J.

AU - Thompson, S. G.

AU - Lilford, R. J.

AU - Bell, P. R.F.

AU - Whitaker, S. C.

AU - Poole-Wilson, P. A.

AU - Ruckley, C. V.

AU - Campbell, W. B.

AU - Dean, M. R.E.

AU - Ruttley, M. S.T.

AU - Coles, E. C.

AU - Halliday, A.

AU - Gibbs, S. J.

AU - Epstein, D.

AU - Hannon, R. J.

AU - Johnston, L.

AU - Bradbury, A. W.

AU - Henderson, M. J.

AU - Parvin, S. D.

AU - Shepherd, D. F.C.

AU - Mitchell, A. W.

AU - Edwards, P. R.

AU - Abbott, G. T.

AU - Higman, D. J.

AU - Vohra, A.

AU - Ashley, S.

AU - Robottom, C.

AU - Wyatt, M. G.

AU - Byrne, D.

AU - Edwards, R.

AU - EVAR-1 trial

AU - DREAM trial

AU - OVER trial

AU - ACE trial

AU - Schurink, Gerardus

AU - de Haan, Michiel

N1 - Funding Information: The individual-patient data meta-analysis was funded by the National Institute for Health Research (NIHR), Health Technology Assessment (HTA) project 11/36/46 as a contract variation (Chief Investigator R. Greenhalgh). There was some support from the Camelia Botnar Research Foundation. They had no role in the study design, in the collection, merging, analysis or reporting of data, in the writing of the report, or in the decision to submit the paper for publication. The views and opinions expressed herein are those of the authors and do not necessarily reflect those of the HTA Programme, NIHR, National Health Service or the Department of Health. Disclosure: The authors declare no conflict of interest. Publisher Copyright: © 2017 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

PY - 2017/2/1

Y1 - 2017/2/1

N2 - 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 EVAR versus 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.

AB - 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 EVAR versus 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.

U2 - 10.1002/bjs.10430

DO - 10.1002/bjs.10430

M3 - (Systematic) Review article

SN - 0007-1323

VL - 104

SP - 166

EP - 178

JO - British Journal of Surgery

JF - British Journal of Surgery

IS - 3

ER -

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

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