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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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.

Abstract

Survival comparable

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Most cited references 10

Record: found
Abstract: found
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A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients.

Eric Steinmetz, , Marc Sapoval … (2011)

Several studies, including three randomized controlled trials (RCTs), have shown that endovascular repair (EVAR) of abdominal aortic aneurysms (AAA) offered better early results than open surgical repair (OSR) but a similar medium-term to long-term mortality and a higher incidence of reinterventions. Thus, the role of EVAR, most notably in low-risk patients, remains debated. The ACE (Anevrysme de l'aorte abdominale: Chirurgie versus Endoprothese) trial compared mortality and major adverse events after EVAR and OSR in patients with AAA anatomically suitable for EVAR and at low-risk or intermediate-risk for open surgery. A total of 316 patients with >5 cm aneurysms were randomized in institutions with proven expertise for both treatments: 299 patients were available for analysis, and 149 were assigned to OSR and 150 to EVAR. Patients were monitored for 5 years after treatment. Statistical analysis was by intention to treat. With a median follow-up of 3 years (range, 0-4.8 years), there was no difference in the cumulative survival free of death or major events rates between OSR and EVAR: 95.9% ± 1.6% vs 93.2% ± 2.1% at 1 year and 85.1% ± 4.5% vs 82.4% ± 3.7% at 3 years, respectively (P = .09). In-hospital mortality (0.6% vs 1.3%; P = 1.0), survival, and the percentage of minor complications were not statistically different. In the EVAR group, however, the crude percentage of reintervention was higher (2.4% vs 16%, P < .0001), with a trend toward a higher aneurysm-related mortality (0.7% vs 4%; P = .12). In patients with low to intermediate risk factors, open repair of AAA is as safe as EVAR and remains a more durable option. Copyright © 2011 Society for Vascular Surgery. Published by Mosby, Inc. All rights reserved.

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Abstract: not found
Article: not found

SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary.

Elliot L Chaikof, David Brewster, Ronald L Dalman … (2009)

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Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR Trials.

Weston Powell, C. Brown, T Wyss-Coray … (2010)

To assess the rate and factors associated with rupture after endovascular aneurysm repair (EVAR) or open repair (OR) of abdominal aortic aneurysm. Graft rupture after EVAR has been reported, often preceded by graft-related complications. Graft rupture has also been reported after OR. By July 2009, a total of 848 elective EVARs and 594 elective ORs were performed in the United Kingdom EVAR trials 1 and 2. Patients were followed up for complications, reinterventions, and rupture. The incidence of rupture was explored in relation to baseline anatomy and subsequent complications in a Cox regression analysis. There were no ruptures in the OR patients. A total of 27 ruptures occurred after EVAR during a mean follow-up of 4.8 years: crude rate = 0.7 [95% confidence interval (CI): 0.5-1.0] ruptures per 100 person-years. Eighteen patients (67%) died within 30 days of rupture. Five ruptures occurred in the first 30 postoperative days and 22 after that: crude rates of rupture = 7.2 (95% CI: 3.0-17.4) and 0.6 (95% CI: 0.4-0.9) per 100 person-years, respectively. Previous complications (endoleak type 1, type 2 with sac expansion, type 3, migration or kinking) increased the risk of rupture, adjusted hazard ratio 8.83 (95% CI 3.76-20.76), P < 0.0001. There were no ruptures after OR and a low rate after EVAR. Mortality after graft rupture is high and previous serious complications are significantly associated with the risk of rupture. Few ruptures after EVAR seem to be spontaneous without complications identified during optimal surveillance.

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Author and article information

Contributors

R. M. Greenhalgh: r.greenhalgh@imperial.ac.uk

R. M. Greenhalgh: Role: Chief Investigator

R.J. Lilford: Role: Chair

the late P.A. Poole‐Wilson: Role: Chair

J. T. Powell: Role: Chair

F. A. Lederle: Role: Co‐Chairperson

J. A. Freischlag: Role: Co‐Chairperson

P. Guarino: Role: Acting Director

M. Antonelli: Role: Assistant Director, Operations

C. Cushing: Role: Programmer

E. Davis: Role: Research Coordinator

L. Durant: Role: Quality Assurance Officer

S. Joyner: Role: Research Coordinator

the late A. Kossack: Role: Research Coordinator

T. C. Kyriakides: Role: Biostatistician

Mary LeGwin: Role: Project Manager

V. McBride: Role: Research Coordinator

T. O'Connor: Role: Biostatistician

J. Poulton: Role: Research Coordinator

the late S. Stratton: Role: Project Manager

S. Zellner: Role: Research Coordinator

C. M. Haakenson: Role: Pharmacist

K.T. Stroupe: Role: Health Economist

Y. Jonk: Role: Health Economist

T. Karrison: Role: Biostatistician

J. P. Matts: Role: Biostatistician

G. D. Huang: Role: Deputy Director, Cooperative Studies Program

Journal

Journal ID (nlm-ta): Br J Surg

Journal ID (iso-abbrev): Br J Surg

Journal ID (doi): 10.1002/(ISSN)1365-2168

Journal ID (publisher-id): BJS

Title: The British Journal of Surgery

Publisher: John Wiley & Sons, Ltd (Chichester, UK )

ISSN (Print): 0007-1323

ISSN (Electronic): 1365-2168

Publication date (Electronic): 03 February 2017

Publication date (Print): February 2017

Volume: 104

Issue: 3 ( doiID: 10.1002/bjs.2017.104.issue-3 )

Pages: 166-178

Affiliations

[ ¹ ] Vascular Surgery Research GroupImperial College London LondonUK

[ ² ] Department of Public Health and Primary CareUniversity of Cambridge CambridgeUK

[ ³ ] Department of SurgeryVU Medical Centre AmsterdamThe Netherlands

[ ⁴ ] Department of MedicineVA Medical Centre, Minneapolis MinnesotaUSA

[ ⁵ ]Vascular Institute of Paris East, Hôpital Privé Paul d'Egine, Champigny, Université, Paris-Est Créteil CréteilFrance

[ ⁶ ]Belfast City Hospital Belfast 53

[ ⁷ ]Birmingham Heartlands Hospital Birmingham 8

[ ⁸ ]Bournemouth General Hospital Bournemouth 68

[ ⁹ ]Charing Cross Hospital London 27

[ ¹⁰ ]Countess of Chester Hospital Chester 15

[ ¹¹ ]Coventry and Walsgrave Hospital Coventry 8

[ ¹² ]Derriford Hospital Plymouth 2

[ ¹³ ]Freeman Hospital Newcastle upon Tyne 121

[ ¹⁴ ]Gartnavel General Hospital Glasgow 12

[ ¹⁵ ]Glasgow Royal Infirmary Glasgow 19

[ ¹⁶ ]Guy's and St Thomas’ Hospital London 124

[ ¹⁷ ]Hull Royal Infirmary Hull 29

[ ¹⁸ ]James Cook University Hospital Middlesborough 19

[ ¹⁹ ]Kent and Canterbury Hospital Canterbury 1

[ ²⁰ ]Lancaster General Infirmary Lancaster 12

[ ²¹ ]Leeds General Infirmary Leeds 38

[ ²² ]Leeds St James's Hospital Leeds 11

[ ²³ ]Leicester Royal Infirmary Leicester 148

[ ²⁴ ]Liverpool Royal Hospital Liverpool 143

[ ²⁵ ]Manchester Royal Infirmary Manchester 96

[ ²⁶ ]New Cross Hospital Wolverhampton 1

[ ²⁷ ]Northern General Hospital Sheffield 77

[ ²⁸ ]Queen Elizabeth Hospital Gateshead 18

[ ²⁹ ]Queen's Medical Centre Nottingham 116

[ ³⁰ ]Royal Cornwall Hospital Truro 26

[ ³¹ ]Royal Free Hospital London 42

[ ³² ]Royal Gwent Hospital Newport 1

[ ³³ ]Royal London Hospital London 7

[ ³⁴ ]Royal Shrewsbury Hospital Shrewsbury 7

[ ³⁵ ]Royal Sussex County Hospital Brighton 6

[ ³⁶ ]Royal United Hospital Bath 34

[ ³⁷ ]Royal Victoria Hospital Belfast 46

[ ³⁸ ]Southampton General Hospital Southampton 39

[ ³⁹ ]Selly Oak Hospital Birmingham 22

[ ⁴⁰ ]St George's Hospital London 54

[ ⁴¹ ]University College Hospital London 69

[ ⁴² ]University Hospital of South Manchester Manchester 127

[ ⁴³ ]Catharina Hospital Eindhoven 94

[ ⁴⁴ ]University Medical Centre Utrecht 35

[ ⁴⁵ ]Academic Medical Centre Amsterdam 32

[ ⁴⁶ ]Erasmus Medical Centre Rotterdam 30

[ ⁴⁷ ]University Hospital Groningen 27

[ ⁴⁸ ]St Franciscus Gasthuis Rotterdam 27

[ ⁴⁹ ]Rijnstate Hospital Arnhem 14

[ ⁵⁰ ]Leyenburg Hospital ‘s‐Gravenhage 9

[ ⁵¹ ]Albert Schweitzer Hospital Dordrecht 8

[ ⁵² ]Atrium Medical Centre Heerlen 8

[ ⁵³ ]Medical Centre Rijnmond Zuid Rotterdam 7

[ ⁵⁴ ]Jeroen Bosch Hospital den Bosch 7

[ ⁵⁵ ]St Elisabeth Hospital Tilburg 5

[ ⁵⁶ ]Maxima Medical Centre Veldhoven 5

[ ⁵⁷ ]Onze Lieve Vrouwe Gasthuis Amsterdam 5

[ ⁵⁸ ]Meander Medical Centre Amersfoort 4

[ ⁵⁹ ]Vlietland Hospital Schiedam 4

[ ⁶⁰ ]University Medical Centre Nijmegen 4

[ ⁶¹ ]Martini Hospital Groningen 3

[ ⁶² ]Medical Centre Haaglanden ‘s‐Gravenhage 3

[ ⁶³ ]Hospital Bernhoven Oss

[ ⁶⁴ ]Oosterschelde Hospital Goes 3

[ ⁶⁵ ]Vrije Universiteit Medical Centre Amsterdam 2

[ ⁶⁶ ]Leiden University Medical Centre Leiden 1

[ ⁶⁷ ]University Medical Centre Maastricht 1

[ ⁶⁸ ]Bronovo Hospital ‘s‐Gravenhage 1Belgium

[ ⁶⁹ ]St Jozef Hospital Turnhout 4

[ ⁷⁰ ]St Trudo Hospital St Truiden 3

[ ⁷¹ ]University Hospital Antwerp 1

[ ⁷² ]University Medical Centre Ghent 1

[ ⁷³ ]Cooperative Studies Program Coordinating Center VA Connecticut Healthcare System West Haven Connecticut

[ ⁷⁴ ]Regulatory Affairs and Clinical Compliance Section, Cooperative Studies Program Clinical Research Pharmacy Coordinating Center

[ ⁷⁵ ]VA Research Site Management and Review Team (SMART)

[ ⁷⁶ ]Center for Management of Complex Care, Veterans Affairs Medical Center (VAMC) Hines Illinois

[ ⁷⁷ ]Center for Chronic Disease Outcomes Research, VAMC Minneapolis Minnesota

[ ⁷⁸ ]Data and Safety Monitoring Board

[ ⁷⁹ ]Human Rights Committee West Haven Connecticut

[ ⁸⁰ ]Central Administration, Cooperative Studies Program (VA Central Office)

[ ⁸¹ ]Director, Clinical Science Research and Development Service

[ ⁸² ]National Project Coordinators, Minneapolis VAMC

[ ⁸³ ]Albuquerque New Mexico

[ ⁸⁴ ]Atlanta Georgia

[ ⁸⁵ ]Baltimore Maryland

[ ⁸⁶ ]Birmingham Alabama

[ ⁸⁷ ]Boston Massachusetts

[ ⁸⁸ ]Buffalo New York

[ ⁸⁹ ]Chicago Illinois

[ ⁹⁰ ]Cincinnati Ohio

[ ⁹¹ ]Cleveland Ohio

[ ⁹² ]Dallas Texas

[ ⁹³ ]Detroit Michigan

[ ⁹⁴ ]Denver Colorado

[ ⁹⁵ ]Durham North Carolina

[ ⁹⁶ ]East Orange New Jersey

[ ⁹⁷ ]Gainesville Florida

[ ⁹⁸ ]Hines Illinois

[ ⁹⁹ ]Houston Texas

[ ¹⁰⁰ ]Indianapolis Indiana

[ ¹⁰¹ ]Iowa City Iowa

[ ¹⁰² ]Lexington Kentucky

[ ¹⁰³ ]Little Rock Arkansas

[ ¹⁰⁴ ]Loma Linda California

[ ¹⁰⁵ ]Long Beach California

[ ¹⁰⁶ ]Madison Wisconsin

[ ¹⁰⁷ ]Memphis Tennessee

[ ¹⁰⁸ ]Milwaukee Wisconsin

[ ¹⁰⁹ ]Minneapolis Minnesota

[ ¹¹⁰ ]New York New York

[ ¹¹¹ ]Omaha Nebraska

[ ¹¹² ]Palo Alto California

[ ¹¹³ ]Philadelphia Pennsylvania

[ ¹¹⁴ ]Pittsburgh Pennsylvania

[ ¹¹⁵ ]Portland Oregon

[ ¹¹⁶ ]Salt Lake City Utah

[ ¹¹⁷ ]San Diego California

[ ¹¹⁸ ]San Francisco California

[ ¹¹⁹ ]Seattle Washington

[ ¹²⁰ ]Tampa Florida

[ ¹²¹ ]Tucson Arizona

[ ¹²² ]Washington DC

[ ¹²³ ]West Haven Connecticut

[ ¹²⁴ ]West Los Angeles California

[ ¹²⁵ ]Centre Hospitalier Universitaire (CHU) Angers–Hôtel Dieu Angers 3

[ ¹²⁶ ]Hôpital privé d'Antony Antony 5

[ ¹²⁷ ]Hôpital Henri Mondor Creteil 102

[ ¹²⁸ ]Clinique mutualiste des Eaux Claires Grenoble 1

[ ¹²⁹ ]Hôpital Européen Georges Pompidou Paris 3

[ ¹³⁰ ]CHU Nord Saint Étienne 14

[ ¹³¹ ]Hôpital Charles Nicolle Rouen 9

[ ¹³² ]Hôpital Trousseau Tours 17

[ ¹³³ ]CHU de Pontchaillou Rennes 2

[ ¹³⁴ ]Hôpital Cardiologique Lille 5

[ ¹³⁵ ]Hôpital Saint Joseph Marseille 11

[ ¹³⁶ ]Hôpital G et R Laennec Nantes 20

[ ¹³⁷ ]Icham Abada Centre Hospitalier René Dubos Pontoise 1

[ ¹³⁸ ]Centre Hospitalier de Valenciennes Valenciennes 4

[ ¹³⁹ ]Nouvelles Cliniques Nantaises Nantes 33

[ ¹⁴⁰ ]Clinique Saint‐Augustin Nantes 25

[ ¹⁴¹ ]Hôpital du Bocage Dijon 15

[ ¹⁴² ]Clinique Pasteur Toulouse 2

[ ¹⁴³ ]Clinique des Franciscaines Nimes 10

[ ¹⁴⁴ ]Hôpital d'adultes de la Timone Marseille 1

[ ¹⁴⁵ ]Hôpital Saint Roch Nice 10

[ ¹⁴⁶ ]Hôpital La Cavale Blanche Brest 2

[ ¹⁴⁷ ]Hôpital Sud Rennes 3

[ ¹⁴⁸ ]Polyclinique de Poitiers Poitiers 2

[ ¹⁴⁹ ]Clinique Marie Immaculée Bourges 6

[ ¹⁵⁰ ]Addenbrookes Hospital Cambridge 10

Author notes

[*] [* ] Correspondence to: Professor R. M. Greenhalgh, Vascular Surgery Research Group, Imperial College London, London W6 8RP, UK (e‐mail: r.greenhalgh@ 123456imperial.ac.uk )

Article

Publisher ID: BJS10430 Other ID: BJS-1075-Jul-16.R1

DOI: 10.1002/bjs.10430

PMC ID: 5299468

PubMed ID: 28160528

SO-VID: 2347ef4f-792e-4d67-8028-08afacd5ba4e

License:

This is an open access article under the terms of the Creative Commons Attribution‐NonCommercial‐NoDerivs License, which permits use and distribution in any medium, provided the original work is properly cited, the use is non‐commercial and no modifications or adaptations are made.

History

Date received : 13 July 2016

Date revision received : 01 September 2016

Date accepted : 26 September 2016

Page count

Figures: 5, Tables: 3, Pages: 13, Words: 8246

Funding

Funded by: National Institute for Health Research

Award ID: NIHR

Funded by: Department of Health

Custom metadata

source-schema-version-number 2.0

component-id bjs10430

cover-date February 2017

details-of-publishers-convertor Converter:WILEY_ML3GV2_TO_NLMPMC version:5.0.5 mode:remove_FC converted:09.02.2017

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ScienceOpen disciplines: Surgery

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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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Abstract

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Results

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Abstract

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SICOT-J (Orthopedic surgery and traumatology)

Most cited references 10

A randomized controlled trial of endovascular aneurysm repair versus open surgery for abdominal aortic aneurysms in low- to moderate-risk patients.

SVS practice guidelines for the care of patients with an abdominal aortic aneurysm: executive summary.

Rate and predictability of graft rupture after endovascular and open abdominal aortic aneurysm repair: data from the EVAR Trials.

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Cited by 84