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

the EVAR-1, DREAM, OVER and ACE Trialists

Research output: Contribution to journalReview article

94 Citations (Scopus)

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 languageEnglish (US)
Pages (from-to)166-178
Number of pages13
JournalBritish Journal of Surgery
Volume104
Issue number3
DOIs
StatePublished - Feb 1 2017

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Abdominal Aortic Aneurysm
Aneurysm
Meta-Analysis
Mortality
Survival
Random Allocation
Ankle Brachial Index
Peripheral Arterial Disease
Multicenter Studies
Coronary Artery Disease

ASJC Scopus subject areas

  • Surgery

Cite this

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. / the EVAR-1, DREAM, OVER and ACE Trialists.

In: British Journal of Surgery, Vol. 104, No. 3, 01.02.2017, p. 166-178.

Research output: Contribution to journalReview article

@article{b7bf9ad7950e48fa8b7f07d6ca7c6d34,
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 = "{the EVAR-1, DREAM, OVER and ACE Trialists} and 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 Greenhalgh, {R. M.} and Beard, {J. D.} and Buxton, {M. J.} and Brown, {L. C.} and Harris, {P. L.} and Powell, {J. T.} 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 Greenhalgh, {R. M.} 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 Powell, {J. T.} and A. Halliday and Gibbs, {S. J.} and Brown, {L. C.} and D. Epstein and Sculpher, {M. J.} and Thompson, {S. G.} 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 Greenhalgh, {R. M.} 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 Gary Lemmon",
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doi = "10.1002/bjs.10430",
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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 - the EVAR-1, DREAM, OVER and ACE Trialists

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 - Greenhalgh, R. M.

AU - Beard, J. D.

AU - Buxton, M. J.

AU - Brown, L. C.

AU - Harris, P. L.

AU - Powell, J. T.

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 - Greenhalgh, R. M.

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 - Powell, J. T.

AU - Halliday, A.

AU - Gibbs, S. J.

AU - Brown, L. C.

AU - Epstein, D.

AU - Sculpher, M. J.

AU - Thompson, S. G.

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 - Greenhalgh, R. M.

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 - Lemmon, Gary

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.

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