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, EVAR-1, DREAM, OVER and ACE Trialists

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.

© 2017 The Authors. BJS published by John Wiley & Sons Ltd on behalf of BJS Society Ltd.

Figures

Figure 1
Figure 1
Kaplan–Meier survival curves for overall total mortality, by randomized group, for all 2783 patients in the four trials combined. EVAR, endovascular aneurysm repair
Figure 2
Figure 2
Unadjusted hazard ratios, with 95 per cent confidence intervals, for total mortality overall and at 0–6 months, 6 months to 4 years and more than 4 years since randomization. EVAR, endovascular aneurysm repair
Figure 3
Figure 3
Odds ratios, with 95 per cent confidence intervals, for mortality within 30 days of operation. EVAR, endovascular aneurysm repair
Figure 4
Figure 4
Unadjusted hazard ratios, with 95 per cent confidence intervals, for total mortality by subgroups of age, sex and estimated glomerular filtration rate (eGFR), overall and at 0–6 months, 6 months to 4 years and more than 4 years since randomization. Interaction P values for age and eGFR were calculated using continuous measures (median eGFR 68·4 ml per min per 1·73 m2). Not all trials contributed to the subgroup analyses or every time point. Hazard ratios for sex could not be estimated in the OVER and ACE trials owing to small numbers of women. EVAR, endovascular aneurysm repair
Figure 5
Figure 5
Unadjusted hazard ratios, with 95 per cent confidence intervals, for total mortality by subgroups of history of angina or myocardial infarction (MI), ankle : brachial pressure index (ABPI) and cardiovascular risk score, overall and at 0–6 months, 6 months to 4 years and more than 4 years since randomization. Interaction P values for ABPI and cardiovascular risk score were calculated using continuous measures. Not all trials contributed to the subgroup analyses or every time point. The ACE trial did not report ABPI so is not included in these results. EVAR, endovascular aneurysm repair

References

    1. Dubost C, Allary M, Oeconomos N. [Treatment of aortic aneurysms; removal of the aneurysm; re‐establishment of continuity by grafts of preserved human aorta.] Mem Acad Chir (Paris) 1951; 77: 381–383.
    1. Greenhalgh RM, Brown LC, Kwong GP, Powell JT, Thompson SG; EVAR trial participants. Comparison of endovascular aneurysm repair with open repair in patients with abdominal aortic aneurysm (EVAR trial 1), 30‐day operative mortality results: randomised controlled trial. Lancet 2004; 364: 843–848.
    1. Blankensteijn JD, de Jong SE, Prinssen M, van der Ham AC, Buth J, van Sterkenburg SM et al; Dutch Randomized Endovascular Aneurysm Management (DREAM) Trial Group. Two‐year outcomes after conventional or endovascular repair of abdominal aortic aneurysms. N Engl J Med 2005; 352: 2398–2405.
    1. Becquemin JP, Pillet JC, Lescalie F, Sapoval M, Goueffic Y, Lermusiaux P et al; ACE trialists. A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low‐to‐moderate‐risk patients. J Vasc Surg 2011; 53: 1167–1173.
    1. Lederle FA, Freischlag JA, Kyriakides TC, Matsumura JS, Padberg FT Jr, Kohler TR et al; OVER Veterans Affairs Cooperative Study Group. Long‐term comparison of endovascular and open repair of abdominal aortic aneurysm. N Engl J Med 2012; 367: 1988–1997.
    1. The UK EVAR Trial Investigators , Greenhalgh RM, Brown LC, Powell JT, Thompson SG, Epstein D, Sculpher MJ. Endovascular versus open repair of abdominal aortic aneurysm. N Engl J Med 2010; 362: 1863–1871.
    1. Paravastu SC, Jayarajasingam R, Cottam R, Palfreyman SJ, Michaels JA, Thomas SM. Endovascular repair of abdominal aortic aneurysm. Cochrane Database Syst Rev 2014; (1)CD004178.
    1. Schermerhorn ML, Buck DB, O'Malley AJ, Curran T, McCallum JC, Darling J et al Long‐term outcomes of abdominal aortic aneurysm in the Medicare population. N Engl J Med 2015; 373: 328–338.
    1. Cronenwett JL. Endovascular aneurysm repair: important mid‐term results. Lancet 2005; 365: 2156–2158.
    1. Kontopodis N, Antoniou SA, Georgakarakos E, Ioannou CV. Endovascular vs open aneurysm repair in the young: systematic review and meta‐analysis. J Endovasc Ther 2015; 22: 897–904.
    1. Brown LC, Epstein D, Manca A, Beard JD, Powell JT, Greenhalgh RM. The UK Endovascular Aneurysm Repair (EVAR) trials: design, methodology and progress. Eur J Vasc Endovasc Surg 2004; 27; 372–381.
    1. Prinssen M, Buskens E, Blankensteijn JD. The Dutch Randomised Endovascular Aneurysm Management (DREAM) trial. Background, design and methods. J Cardiovasc Surg (Torino) 2002; 43: 379–384.
    1. . Standard Open Surgery Versus Endovascular Repair of Abdominal Aortic Aneurysm (AAA) (OVER) . [accessed 2 March 2016].
    1. Levey AS, Bosch JP, Lewis JB, Greene T, Rogers N, Roth D. A more accurate method to estimate glomerular filtration rate from serum creatinine: a new prediction equation. Modification of Diet in Renal Disease Study Group. Ann Intern Med 1999; 130: 461–470.
    1. Wilkins JT, Ning H, Berry J, Zhao L, Dyer AR, Lloyd‐Jones DM. Lifetime risk and years lived free of total cardiovascular disease. JAMA 2012; 308: 1795–1801.
    1. Parner ET, Andersen PK. Regression analysis of censored data using pseudo‐observations. Stata J 2010; 10: 408–422.
    1. DerSimonian R, Laird N. Meta‐analysis in clinical trials. Control Clin Trials 1986; 7: 177–188.
    1. Higgins JP, Thompson SG, Deeks JJ, Altman DG. Measuring inconsistency in meta‐analyses. BMJ 2003; 327: 557–560.
    1. Reise JA, Sheldon H, Earnshaw J, Naylor AR, Dick F, Powell JT et al Patient preference for surgical method of abdominal aortic aneurysm repair: postal survey. Eur J Vasc Endovasc Surg 2010; 39: 55–61.
    1. Mani K, Bjorck M, Wanhainen A. Changes in the management of infrarenal abdominal aortic aneurysm disease in Sweden. Br J Surg 2013; 100: 638–444.
    1. Sumner DS, Strandness DE. The relationship between calf blood flow and ankle pressure in patients with intermittent claudication. Surgery 1969; 65: 763–771.
    1. Heald CL, Fowkes FG, Murray GD, Price JF; Ankle Brachial Index Collaboration. Risk of mortality and cardiovascular disease associated with the ankle/brachial index: systematic review. Atherosclerosis 2006; 189: 61–69.
    1. Saratzis A, Sarafidis P, Melas N, Saratzis N, Kitas G. Impaired renal function is associated with mortality and morbidity after endovascular abdominal aortic aneurysm repair. J Vasc Surg 2013; 58: 879–885.
    1. Chaikof EL, Brewster DC, Dalman RL, Makaroun MS, Illig KA, Sicard GA et al SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary. J Vasc Surg 2009; 50: 880–896.
    1. Wyss TR, Brown LC, Powell JT, Greenhalgh RM. Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR trials. Ann Surg 2010; 252: 805–812.

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