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Meta-Analysis
. 2017 Feb;104(3):166-178.
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

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Free PMC article
Meta-Analysis

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 et al. Br J Surg. .
Free PMC article

Erratum in

  • Corrigenda.
    Br J Surg. 2018 Aug;105(9):1222. doi: 10.1002/bjs.10928. Br J Surg. 2018. PMID: 30461004 Free PMC article. No abstract available.

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.

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

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