1. 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
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Powell, JT, Sweeting, MJ, Ulug, P, Blankensteijn, JD, Lederle, FA, Becquemin, J‐P, 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, the late 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, Leiberman, DP, McCarter, DH, Taylor, PR, Reidy, JF, Wilkinson, AR, Ettles, DF, Clason, AE, Leen, GLS, Wilson, NV, Downes, M, Walker, SR, Lavelle, JM, Gough, MJ, McPherson, S, Scott, DJA, Kessell, DO, Naylor, R, Sayers, R, Fishwick, NG, Gould, DA, Walker, MG, Chalmers, NC, Garnham, A, Collins, MA, Gaines, PA, Ashour, MY, Uberoi, R, Braithwaite, B, Davies, JN, Travis, S, Hamilton, G, Platts, A, Shandall, A, Sullivan, BA, Sobeh, M, Matson, M, Fox, AD, Orme, R, Yusef, W, Doyle, T, Horrocks, M, Hardman, J, Blair, PHB, Ellis, PK, and Morris, G
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Biomedical and Clinical Sciences ,Cardiovascular Medicine and Haematology ,Clinical Sciences ,Clinical Research ,Clinical Trials and Supportive Activities ,Cardiovascular ,Evaluation of treatments and therapeutic interventions ,6.4 Surgery ,Good Health and Well Being ,Aged ,Aged ,80 and over ,Aortic Aneurysm ,Abdominal ,Elective Surgical Procedures ,Endovascular Procedures ,Female ,Humans ,Male ,Middle Aged ,Models ,Statistical ,Multicenter Studies as Topic ,Randomized Controlled Trials as Topic ,Reoperation ,Treatment Outcome ,Vascular Grafting ,EVAR-1 ,DREAM ,OVER and ACE Trialists ,Medical and Health Sciences ,Surgery ,Clinical sciences - Abstract
BackgroundThe 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.MethodsAn 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.ResultsThe 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.ConclusionThe 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.
- Published
- 2017