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

    106 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{6913fd60848a4818ade57ef7b561781b,
    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 Moneta, {Gregory (Greg)} and Gregory Landry",
    year = "2017",
    month = "2",
    day = "1",
    doi = "10.1002/bjs.10430",
    language = "English (US)",
    volume = "104",
    pages = "166--178",
    journal = "British Journal of Surgery",
    issn = "0007-1323",
    publisher = "John Wiley and Sons Ltd",
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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 - Moneta, Gregory (Greg)

    AU - Landry, Gregory

    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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    U2 - 10.1002/bjs.10430

    DO - 10.1002/bjs.10430

    M3 - Review article

    C2 - 28160528

    AN - SCOPUS:85011797685

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    EP - 178

    JO - British Journal of Surgery

    JF - British Journal of Surgery

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