A systematic review and meta-analysis of the long-term outcomes of endovascular versus open repair of abdominal aortic aneurysm

A systematic review and meta-analysis of the long-term outcomes of endovascular versus open repair of abdominal aortic aneurysm Ben Li, BHSc,a Shawn Khan, BHSc,a Konrad Salata, MD,a Mohamad A. Hussain, MD, PhD,a Charles de Mestral, MD, PhD,a Elisa Greco, MD, MEd,a Badr A. Aljabri, MD,a,b Thomas L. Forbes, MD,c Subodh Verma, MD, PhD,d and Mohammed Al-Omran, MD, MSc,a,b Toronto, Ontario, Canada; and Riyadh, Kingdom of Saudi Arabia

ABSTRACT Objective: This study synthesized the literature comparing the long-term (5-9 years) and very long-term ($10 years) all-cause mortality, reintervention, and secondary rupture rates between endovascular aneurysm repair (EVAR) and open surgical repair (OSR) of abdominal aortic aneurysm (AAA). Methods: MEDLINE, Embase, and CENTRAL databases were searched from inception to May 2018 for studies comparing EVAR to OSR with a minimum follow-up period of 5 years. Study selection, data abstraction, and quality assessment were conducted by two independent reviewers, with a third author resolving discrepancies. Study quality was assessed using the Cochrane and Newcastle-Ottawa scales. Pooled odds ratios (ORs) with 95% confidence intervals (CIs) were calculated using random-effects models. Heterogeneity was quantified using the I2 statistic, and publication bias was assessed using funnel plots. Results: Our search yielded 3431 unique articles. Three randomized controlled trials and 68 observational studies comparing 151,092 EVAR to 148,692 OSR patients were included. Inter-rater agreement was excellent at the screening (k ¼ 0.78) and full-text review (k ¼ 0.89) stages. Overall, the risk of bias was low to moderate. For long-term outcomes, 54 studies reported all-cause mortality (n ¼ 203,246), 23 reported reintervention (n ¼ 157,151), and 4 reported secondary rupture (n ¼ 150,135). EVAR was associated with higher long-term all-cause mortality (OR, 1.19; 95% CI, 1.06-1.33; P ¼ .003, I2 ¼ 91%), reintervention (OR, 2.12; 95% CI, 1.67-2.69; P < .00001, I2 ¼ 96%), and secondary rupture rates (OR, 4.84; 95% CI, 2.63-8.89; P < .00001, I2 ¼ 92%). For very long-term outcomes, 15 studies reported all-cause mortality (n ¼ 48,721), 9 reported reintervention (n ¼ 7511), and 1 reported secondary rupture (n ¼ 1116). There was no mortality difference between groups, but EVAR was associated with higher reintervention (OR, 2.47; 95% CI, 1.71-3.57; P < .00001, I2 ¼ 84%) and secondary rupture rates (OR, 8.10; 95% CI, 1.01-64.99; P ¼ .05). Subanalysis of more recent studies, with last year of patient recruitment 2010 or after, demonstrated no long-term mortality differences between EVAR and OSR. Conclusions: EVAR is associated with higher long-term all-cause mortality, reintervention, and secondary rupture rates compared with OSR. In the very long-term, EVAR is also associated with higher reintervention and secondary rupture rates. Notably, EVAR mortality has improved over time. Vigilant long-term surveillance of EVAR patients is recommended. (J Vasc Surg 2019;-:1-16.) Keywords: Abdominal aortic aneurysm (AAA); Endovascular aneurysm repair (EVAR); Long-term outcomes; Open surgical repair (OSR); Systematic review

Abdominal aortic aneurysm (AAA) affects 4.8% of the general population1 and is the 14th leading cause of death in the United States.2 The pathogenesis of this condition remains unclear but may be related to macrophage and endothelial autophagy.3 Surgical management options for AAA include traditional open surgical repair (OSR) and minimally invasive endovascular aneurysm repair (EVAR). Early randomized controlled trials (RCTs) demonstrated improved perioperative mortality

for EVAR compared with OSR.4,5 However, longer follow-up of these trials showed similar mortality between techniques and higher reintervention rates for EVAR.6,7 This was likely because EVAR suffered from endograft-specific complications, including endoleak, graft migration, and fracture, all of which reduced its long-term durability.8 Despite these results, national guidelines continue to recommend EVAR over OSR for anatomically suitable patients.9

From the Division of Vascular Surgery,a and Division of Cardiac Surgery,d Li Ka

Correspondence: Mohammed Al-Omran, MD, MSc, FRCSC, Head, Division of

Shing Knowledge Institute of St. Michael’s Hospital and University of Toronto,

Vascular Surgery, St. Michael’s Hospital, 30 Bond St, Ste 7-074, Bond Wing,

Toronto; the Department of Surgery, King Saud University, Riyadhb; and the Division of Vascular Surgery, Peter Munk Cardiac Centre and University Health Network and University of Toronto, Toronto.c Author conflict of interest: none. Additional material for this article may be found online at www.jvascsurg.org.

Toronto, ON M5B 1W8, Canada (e-mail: [email protected]). The editors and reviewers of this article have no relevant financial relationships to disclose per the JVS policy that requires reviewers to decline review of any manuscript for which they may have a conflict of interest. 0741-5214 Copyright Ó 2019 by the Society for Vascular Surgery. Published by Elsevier Inc. https://doi.org/10.1016/j.jvs.2019.01.076

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An increasing number of RCTs and observational studies reporting long-term outcomes of EVAR vs OSR have been published in recent years. Some favored EVAR,10,11 others favored OSR,12,13 and many demonstrated no differences between interventions.14-17 Comparisons of long-term outcomes between EVAR and OSR have been previously summarized through systematic reviews and meta-analyses.18-21 However, these studies only included data from RCTs18,19 or statewide databases20 or were methodologically limited by arbitrary study selection criteria.21 Others only examined short-term outcomes.22,23 Furthermore, a considerable amount of new data have been published recently. Given the lack of consensus from individual studies and the absence of a comprehensive summary of results, we conducted a systematic review and meta-analysis of RCTs and observational studies to synthesize the longterm and very long-term all-cause mortality, reintervention, and secondary rupture rates of EVAR vs OSR for AAA management.

METHODS Protocol and registration. We conducted a systematic review according to the 2009 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement guidelines.24 Our study protocol was registered with the International Prospective Register of Systematic Reviews (PROSPERO), #CRD42018096836. Information sources and search strategy. Our search strategy was devised in consultation with a cardiovascular librarian. We searched the Ovid versions of MEDLINE and MEDLINE Daily, including e-publications, in progress, and nonindexed citations, Embase Classic and Embase, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception (1946 for MEDLINE, 1947 for Embase, variable for CENTRAL) to May 2018 for studies comparing EVAR to OSR for AAA management. A combination of medical subject heading terms and keywords for AAA, EVAR, and OSR were used to maximize search sensitivity. We hand-searched the reference lists of relevant systematic reviews identified by our strategy for additional articles. Our search was limited to human studies, and we did not apply language limitations. The search strategy is detailed in Supplementary Table I (online only). Study selection and data collection. Title and abstract screening, full-text review, data collection, and risk of bias assessment were conducted by two independent reviewers (B.L. and S.K.), with a third author resolving discrepancies (K.S.). We included all RCTs and observational studies that compared all-cause mortality, reintervention, and secondary rupture rates between EVAR and OSR for infrarenal AAA management with a minimum follow-up period of 5 years. The follow-up period was defined as the maximum follow-up time reported by each study with a comparison between EVAR and

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OSR. Reintervention was defined as any secondary procedure performed to treat complications related to the initial AAA repair, including graft-related and accessrelated complications. Case reports, case series (<20 patients), and reviews were excluded. Studies that passed title and abstract screening underwent full-text review for inclusion in the systematic review. Data collection for included studies was performed using a standardized electronic form. Collected variables included study authors, year of publication, country, design, recruitment period, sample size, maximum follow-up, outcomes reported, baseline patient demographics and clinical characteristics, and effect size measurements. Authors were contacted through e-mail correspondence for baseline covariates and effect size measurements stratified by EVAR vs OSR if they were not reported in the original publication. GetData Graph Digitizer 2.26 (www.getdata-graphdigitizer.com) was used to interpolate numerical data from survival curves if raw values were not reported and authors did not provide data after e-mail correspondence.25 This software has been used previously for systematic reviews and meta-analyses.26-28 Study quality was assessed using the Cochrane Collaboration risk of bias tool for RCTs29 and the NewcastleOttawa Scale (NOS)30 for observational studies. Data analysis. We calculated a k statistic to assess interrater agreement at the title/abstract screening and fulltext review stages, with thresholds of 0.61 to 0.80 and $0.81 indicating substantial and nearly perfect agreement, respectively, as defined by McHugh.31 We conducted a meta-analysis of long-term and very long-term all-cause mortality, reintervention, and secondary rupture rates for EVAR vs OSR using published data and any additional data provided by authors. We defined long-term and very long-term outcomes as those reported in studies with a minimum follow-up period of 5 to 9 years and $10 years, respectively. Pooled odds ratios (OR) with 95% confidence intervals (CI) were calculated, with significance set at P < .05. Sensitivity analyses were conducted by excluding studies with a high probability of bias (NOS score #5 or high risk of bias according to the Cochrane Collaboration tool). Heterogeneity was quantified using the I2 statistic, and publication bias was assessed using funnel plots. We conducted subgroup analysis of RCTs only to reduce heterogeneity and selection bias inherent in observational studies. Subgroup analysis was also performed by the last year of patient recruitment, with studies grouped into older (before 2010) or more recent (2010 and after). This assessed for the potential impact of improvements in EVAR technology and technical skill over time. Verzini et al32 demonstrated that stent grafts introduced after 2004 had lower incidences of conversion to open repair and sac expansion than older devices.

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Fig 1. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) flow diagram. AAA, Abdominal aortic aneurysm; EVAR, endovascular aneurysm repair; FEVAR, fenestrated endovascular aneurysm repair; OSR, open surgical repair.

Given that there is no established date for the commencement of modern EVAR in the literature, the year of 2010 was chosen to be the cutoff for our study to allow time for newer-generation grafts to be used in a more widespread manner. All analyses were conducted using Review Manager 5.3 (The Nordic Cochrane Centre, The Cochrane Collaboration, Copenhagen, Denmark) based on random-effects models.

RESULTS Search, screening, and full-text review. We identified 5854 articles through our search of MEDLINE (n ¼ 2985), Embase (n ¼ 2624), and CENTRAL (n ¼ 245). Of these, 3431 articles remained after duplicates were removed, all of which underwent title and abstract screening. We excluded 3167 articles, and 264 remained for full-text review. Hand search of reference lists of 33 systematic reviews comparing EVAR vs OSR identified through our strategy yielded no additional relevant articles. After the full-text review, 191 articles were excluded because they had <5 years of follow-up (n ¼ 118), were

commentaries (n ¼ 17), had no EVAR vs OSR comparison (n ¼ 13), did not report an outcome of interest (n ¼ 10), were not original publications (n ¼ 10), were reviews (n ¼ 10), used duplicate data from an included study (n ¼ 6), included ruptured AAA (n ¼ 3), included only fenestrated EVAR patients (n ¼ 2), or were trial protocols with no results (n ¼ 2). The systematic review and meta-analysis included 73 articles. Inter-rater agreement was excellent at the screening (k ¼ 0.78) and full-text review (k ¼ 0.89) stages. Our search results are summarized in the PRISMA study flow diagram in Fig 1. Study characteristics. We included three RCTs (five articles) and 68 observational studies (six prospective cohort studies and 62 retrospective cohort studies) published between 1999 and 2018. Two RCTs (Dutch Randomised Endovascular Aneurysm Management [DREAM] and United Kingdom Endovascular Aneurysm Repair Trial 1 [EVAR-1]) published one report each at 5 to 9 years and >10 years of follow-up, which were analyzed separately as long-term and very long-term outcomes. All-cause mortality was reported in 69 studies (54

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long-term and 15 very long-term), 32 reported reintervention (23 long-term and 9 very-long-term), and 6 reported secondary rupture (5 long-term and 1 very longterm). In total, 299,784 patients were included (151,092 EVAR vs 148,692 OSR patients). The sample sizes of the included studies varied considerably, ranging from 19 EVAR vs eight OSR patients to 39,966 EVAR vs 39,966 OSR patients. Maximum length of follow-up ranged from 5 to 15 years. Most studies were published in the United States (28%) or United Kingdom (13%). The characteristics of included studies are summarized in the Table.33-96 Patient characteristics. The mean age of patients ranged from 57 to 84 years (EVAR) and 56 to 83 years (OSR). The percentage of men ranged from 41% to 100% (EVAR) and 38% to 100% (OSR). The baseline AAA diameter ranged from 5.0 to 6.4 cm (EVAR) and 5.1 to 6.7 cm (OSR). Patient comorbidities, including hypertension, dyslipidemia, diabetes, coronary artery disease, cerebrovascular disease, chronic obstructive pulmonary disease, chronic kidney disease, and smoking status, varied widely across studies but were generally comparable between EVAR and OSR groups. Similarly, patient medications, including antiplatelet, anticoagulant, b-blocker, and statin therapy, were generally comparable between groups. Baseline covariate data for included studies are presented in Supplementary Table II (online only). Study quality. The three RCTs were judged to be at low risk of bias. Of the 68 observational studies, 15 were low risk (NOS score $8), 45 were moderate risk (NOS score 6-7), and 8 were high risk (NOS score #5). A common issue contributing to bias in observational studies was poor comparability of cohorts owing to lack of or inadequate statistical adjustment for confounding variables, with 34 studies receiving a score of 0/2 and 20 studies receiving a score of 1/2 on this criterion. Furthermore, many studies did not report the number of patients lost to follow-up. Fifty-two studies received a score of 0/1 on adequacy of follow-up. A summary of study quality assessment is presented in Supplementary Table III. (online only). Meta-analysis of EVAR vs OSR all-cause mortality. Fiftyfour studies with a total of 203,246 patients (93,779 EVAR vs 109,467 OSR) assessed long-term (5-9 years) all-cause mortality. Meta-analysis demonstrated that EVAR patients had significantly higher long-term all-cause mortality of 27.3% vs 24.7% (OR, 1.19; 95% CI, 1.06-1.33; P ¼ .003, I2 ¼ 91%; Fig 2). The funnel plot showed minimal evidence of publication bias (Supplementary Fig 1). Sensitivity analysis removing nine studies with a high risk of bias continued to show that EVAR was associated with higher mortality (OR, 1.14; 95% CI, 1.01-1.28; P ¼ .04; Supplementary Fig 2). Heterogeneity remained high (I2 ¼ 92%).

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Subgroup analysis of three RCTs (1,243 EVAR vs 1,241 OSR patients) demonstrated no mortality difference between groups (OR, 0.98; 95% CI, 0.83-1.15; P ¼ .78), with low heterogeneity (I2 ¼ 0%; Supplementary Fig 3). Subgroup analysis of 35 older studies with the last year of patient recruitment before 2010 (70,287 EVAR vs 74,881 OSR patients) showed that EVAR patients had higher longterm all-cause mortality (OR, 1.13; 95% CI, 1.03-1.25; P ¼ .01, I2 ¼ 84%; Supplementary Fig 4, online only). In contrast, 19 newer studies with last year of patient recruitment 2010 or after (23,492 EVAR vs 34,586 OSR patients) demonstrated no mortality difference between groups (OR, 1.42; 95% CI, 0.99-2.04; P ¼ .06, I2 ¼ 94%; Supplementary Fig 5, online only). We performed a sample size calculation with significance set at 0.05 and power set at 0.8. Survival estimates were derived from a similar systematic review by Takagi et al,97 with a hazard ratio of 1.29 and 5-year survival of 75.8% for EVAR and 78.8% for OSR. The required sample size for adequate power was 2154 patients per arm, and this subgroup analysis included 23,492 EVAR and 34,586 OSR patients. For sensitivity and subgroup analysis, two funnel plots showed minimal evidence of publication bias, one showed some evidence of publication bias with missing low-quality studies favoring EVAR, and one was not interpretable due to a paucity of studies. Very long-term ($10 years) all-cause mortality was reported in 15 studies with a total of 48,721 patients (33,370 EVAR vs 15,351 OSR). Meta-analysis demonstrated no mortality difference between groups (OR, 0.92; 95% CI, 0.76-1.11; P ¼ .39, I2 ¼ 89%; Fig 3). The funnel plot showed minimal evidence of publication bias (Supplementary Fig 6, online only). No studies with a high risk of bias were identified. Subgroup analysis of two RCTs (799 EVAR vs 804 OSR patients) also demonstrated no mortality difference between groups (OR, 1.21; 95% CI, 0.97-1.50; P ¼ .09, I2 ¼ 0%; Supplementary Fig 7, online only). Subgroup analysis of five older studies (1176 EVAR vs 1232 OSR patients) showed that EVAR patients had higher very long-term all-cause mortality (OR, 1.21; 95% CI, 1.01-1.45; P ¼ .04, I2 ¼ 0%; Supplementary Fig 8, online only). In contrast, 10 newer studies (32,194 EVAR vs 14,119 OSR patients) demonstrated no mortality difference between groups (OR, 0.81; 95% CI, 0.65-1.03; P ¼ .08, I2 ¼ 92%; Supplementary Fig 9, online only). On the basis of the sample size calculation performed using survival estimates derived from Takagi et al,97 2154 patients per arm were required for adequate power. This subanalysis included 32,194 EVAR and 14,119 OSR patients. For subgroup analysis, two funnel plots showed minimal evidence of publication bias, and one was not interpretable due to a paucity of studies. Meta-analysis of EVAR vs OSR reintervention rate. Long-term reintervention rate was reported in 23 studies with a total of 157,151 patients (79,384 EVAR vs 77,767 OSR). Meta-analysis demonstrated that EVAR patients had a

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Table. Summary of included studies

Author

Year 6,16

Country

Design

Recruitment period

Sample size EVAR

OSR

Max follow-up, years

Outcomes

a

All-cause mortality, reintervention, secondary rupture All-cause mortality, reintervention

DREAM

2017

The Netherlands

RCT

2000-2003

173

178

6 or 12

EVAR-17,33

2016

UK

RCT

1999-2004

626

626

8 or 15b

OVER17

2012

U.S.

RCT

2002-2008

444

437

9

All-cause mortality, reintervention, secondary rupture

Antonello34

2013

Italy

PC

2003-2007

160

243

9

All-cause mortality, reintervention

Peterson35

2007

U.S.

PC

1998-2000

235

99

5

All-cause mortality

Goueffic

2005

France

PC

1995-2001

209

289

6

All-cause mortality

Torsello37

2005

Germany

PC

1996-1998

20

20

6

All-cause mortality, reintervention

Cao38

2004

Italy

PC

1997-2003

534

585

7

All-cause mortality, reintervention

Moore39

2003

U.S.

PC

1995-1998

573

111

5

All-cause mortality, secondary rupture

Chandra40

2018

U.S.

RC

1995-2014

164

108

10

Chiang41

2018

NZ

RC

1996-2010

344

692

10

All-cause mortality

Majd42

2018

Germany

RC

1998-2015

131

46

5

All-cause mortality

O’Donnell43

2018

U.S.

RC

2003-2017

27,687

7189

10

All-cause mortality

Bae44

2017

Korea

RC

2007-2014

58

40

8

All-cause mortality

Behrendt

2017

Germany

RC

2008-2015

3493

1457

6

All-cause mortality

Chinsakchai13

2017

Thailand

RC

2007-2011

77

70

5

All-cause mortality

Laine46

2017

Finland

RC

2000-2014

1644

3312

10

All-cause mortality

Law47

36

45

All-cause mortality, reintervention

2017

Hong Kong

RC

1999-2013

104

30

5

All-cause mortality

48

2017

Germany

RC

1998-2006

108

108

10

All-cause mortality, reintervention

Martinez Gallego49

2017

Spain

RC

2007-2014

165

65

8

All-cause mortality, reintervention

Mazzaccaro50

2017

Italy

RC

2000-2014

660

452

10

All-cause mortality, reintervention

Sugimoto51

2017

Japan

RC

2007-2014

157

157

5

All-cause mortality, reintervention

Yang52

2017

Korea

RC

2005-2014

53

46

5

Reintervention

Calvin Alvarez53

2016

Spain

RC

2008-2009

34

40

5

All-cause mortality, reintervention

2016

UK

RC

2002-2013

16,777

31,090

5

All-cause mortality

Dunschede

2016

Germany

RC

2002-2008

68

72

10

All-cause mortality, reintervention

Khashram55

2016

Australia

RC

1990-2013

358

982

15

All-cause mortality

Machado

2016

Portugal

RC

2001-2013

171

121

10

All-cause mortality

Morisaki57

2016

Japan

RC

2007-2011

117

90

5

All-cause mortality, reintervention

Sirignano58

2016

Italy

RC

2005-2014

49

70

5

All-cause mortality, reintervention

Yazbek59

2016

Brazil

RC

2003-2013

19

8

5

All-cause mortality

Majd

Desai10 54

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Table. Continued.

Author

Year

15

Country

Sample size

Design

Recruitment period

EVAR

OSR

2001-2009

12,239

11,431

Chang

2015

U.S.

RC

de Leur60

2015

The Netherlands

RC

2005-2012

120

Huang61

2015

U.S.

RC

2000-2011

558

Lee62

2015

Canada

RC

2000-2013

50

Saratzis63

2015

UK

RC

2004-2012

947

Schermerhorn14

2015

U.S.

RC

2001-2008

39,966

Thomas64

2015

U.S.

RC

2006-2011

Yamamoto65

2015

Japan

RC

2007-2014

Kovacs66

2014

Hungary

RC

2007-2012

Pane67

2014

Italy

RC

2005-2010

Sandford68

2014

UK

RC

2013

U.S.

Altaf70

2013

De Martino71 Goodyear72

Max follow-up, years

Outcomes

9

All-cause mortality, secondary rupture

105

5

All-cause mortality

558

10

All-cause mortality, reintervention, secondary rupture

119

10

All-cause mortality

121

5

All-cause mortality, reintervention

39,966

8

All-cause mortality, reintervention

497

135

6

All-cause mortality

426

348

5

All-cause mortality, reintervention

59

431

6

All-cause mortality

51

121

5

All-cause mortality

2000-2010

59

99

5

Reintervention

RC

1996-2011

558

586

15

All-cause mortality, reintervention

UK

RC

1994-2012

97

68

7

All-cause mortality, reintervention

2013

U.S.

RC

2003-2011

1653

714

5

All-cause mortality

2013

UK

RC

2003-2007

25

103

7

All-cause mortality

Ito73

2013

Japan

RC

1999-2006

19

218

5

All-cause mortality

Lee74

2013

U.S.

RC

1996-2004

220

220

10

All-cause mortality

Mark75

2013

U.S.

RC

2000-2006

4483

4483

5

All-cause mortality

Mujib76

2013

U.S.

RC

1985-2009

1005

903

12

Hinterseher77

2012

Germany

RC

1995-2005

54

151

7

Jackson

2012

U.S.

RC

2003-2007

3826

703

5

All-cause mortality

Min78

2012

Korea

RC

2005-2009

26

79

5

All-cause mortality

Ren79

2012

China

RC

1998-2008

89

136

10

All-cause mortality

Capoccia80

2011

Italy

RC

2002-2009

29

53

5

All-cause mortality

81

2011

U.S.

RC

2001-2004

22,826

22,826

6

Reintervention, secondary rupture

2011

U.S.

RC

1985-2009

1066

920

7

All-cause mortality

Al-Jubouri

69

11

Giles

Quinney82 83

Reintervention All-cause mortality

Cochennec

2010

France

RC

1998-2008

68

63

5

All-cause mortality, reintervention

Dias84

2010

Portugal

RC

2001-2009

77

107

7

All-cause mortality, reintervention

Jetty85

2010

Canada

RC

2002-2007

888

5573

5

All-cause mortality

Steinmetz86

2010

France

RC

1999-2006

148

134

5

All-cause mortality

Mani87

2009

Sweden

RC

1987-2005

855

2922

5

All-cause mortality

Berge88

2008

Norway

RC

1983-2002

136

606

5

All-cause mortality

Diehm89

2008

U.S.

RC

1994-2007

25

25

9

All-cause mortality, reintervention

Paolini90

2008

U.S.

RC

1996-2006

81

69

5

All-cause mortality

Schouten91

2008

The Netherlands

RC

2000-2006

55

69

6

All-cause mortality

Wahlgren92

2008

Sweden

RC

2000-2006

1000

2831

5

All-cause mortality

Aune93

2007

Norway

RC

1995-2005

118

386

5

All-cause mortality

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Table. Continued.

Author

Year 94

Country

Design

Recruitment period

Sample size EVAR

OSR

Max follow-up, years

Outcomes

Chahwan

2007

U.S.

RC

1996-2005

260

417

5

All-cause mortality

Mistry95

2007

South Africa

RC

1998-2005

122

156

6

All-cause mortality, reintervention

Moore96

1999

U.S.

RC

1992-1998

100

100

5

All-cause mortality

DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR, endovascular aneurysm repair; EVAR-1, United Kingdom Endovascular Aneurysm Repair Trial 1; NZ, New Zealand; OSR, open surgical repair; PC, prospective cohort; RC, retrospective cohort; RCT, randomized controlled trial; UK, United Kingdom; US, United States. a DREAM reported $5-year follow-up data at 6 years (long-term) and 12 years (very long-term). b EVAR-1 reported $5-year follow-up data at 8 years (long-term) and 15 years (very long-term).

higher long-term reintervention rate of 17.6% vs 14.9% (OR, 2.12; 95% CI, 1.67-2.69; P < .00001, I2 ¼ 96%; Fig 4). The funnel plot showed evidence of publication bias with missing low-quality studies favoring EVAR (Supplementary Fig 10, online only). Sensitivity analysis excluding two studies with a high risk of bias and one outlier continued to demonstrate that EVAR was associated with more reinterventions (OR, 2.05; 95% CI, 1.612.62; P < .00001, I2 ¼ 96%; Supplementary Fig 11, online only). Subgroup analysis of three RCTs (1243 EVAR vs 1241 OSR patients) also showed a higher reintervention rate for EVAR patients (OR, 1.98; 95% CI, 1.12-3.51; P ¼ .02, I2 ¼ 85%; Supplementary Fig 12, online only). EVAR was associated with higher reintervention rates in both older (OR, 2.08; 95% CI, 1.59-2.72; P < .00001, I2 ¼ 97%) and newer publications (OR, 2.43; 95% CI, 1.33-4.44; P ¼ .004, I2 ¼ 60%; Supplementary Figs 13 and 14, online only). For sensitivity and subgroup analysis, two funnel plots showed evidence of publication bias with missing low-quality studies favoring EVAR, one had missing low-quality studies favoring OSR, and one was not interpretable due to a paucity of studies. Nine studies with a total of 7511 patients (3,920 EVAR vs 3,591 OSR) reported very long-term reintervention rate. Meta-analysis demonstrated that EVAR patients had a higher very long-term reintervention rate of 20.9% vs 12.3% (OR, 2.47; 95% CI, 1.71-3.57; P < .00001, I2 ¼ 84%; Fig 5). The funnel plot showed evidence of publication bias with missing low-quality studies favoring EVAR (Supplementary Fig 15, online only). No studies with a high risk of bias or outliers were identified. Subgroup analysis of two RCTs (799 EVAR vs 804 OSR patients) continued to show that EVAR was associated with more reinterventions (OR, 2.45; 95% CI, 1.90-3.17; P < .00001, I2 ¼ 0%; Supplementary Fig 16, online only). EVAR patients had a higher very long-term reintervention rate in both older (OR, 2.41; 95% CI, 1.33-4.39; P ¼ .004, I2 ¼ 89%) and newer publications (OR, 2.55; 95% CI, 2.04-3.20; P < .00001, I2 ¼ 5%; Supplementary Figs 17 and 18, online only). For subgroup analysis, two funnel plots showed evidence of publication bias with missing low-quality studies favoring EVAR, and one was not interpretable due to a paucity of studies.

Meta-analysis of EVAR vs OSR secondary rupture rate. Four studies with a total of 150,135 patients (75,475 EVAR vs 74,660 OSR patients) reported long-term secondary rupture rate. Moore et al39 was excluded from the metaanalysis because the event rate was 0% in both EVAR and OSR groups, leading to a nonestimable OR. Metaanalysis of the included studies demonstrated that EVAR patients had a higher long-term secondary rupture rate of 2.0% vs 0.6% (OR, 4.84; 95% CI, 2.63-8.89; P < .00001, I2 ¼ 92%; Fig 6). The funnel plot showed evidence of publication bias with missing low-quality studies favoring EVAR (Supplementary Fig 19, online only). No studies with a high risk of bias or outliers were identified. Only one RCT, Open versus Endovascular Repair Veterans Affairs Cooperative Study (OVER17), reported long-term secondary rupture rate. The study compared 444 EVAR to 437 OSR patients and demonstrated that EVAR was associated with a higher secondary rupture rate (P ¼ .03). Subgroup analysis based on the last year of patient recruitment was not applicable because no recent studies (2010 or after) were identified. One study by Huang et al61 reported very long-term secondary rupture rate, which compared 558 EVAR to 558 OSR patients and demonstrated that EVAR patients had a higher very long-term secondary rupture rate (OR, 8.10; 95% CI, 1.01-64.99; P ¼ .05). Subgroup analyses were not applicable because only one study was included.

DISCUSSION This systematic review and meta-analysis of 73 studies including 299,784 patients demonstrated that EVAR was associated with higher long-term all-cause mortality, reintervention, and secondary rupture rates compared with OSR. In the very long-term, EVAR was also associated with higher reintervention and secondary rupture rates. There was no difference in very long-term mortality between groups, potentially due to a reduced sample size compared with analysis of outcomes at 5 to 9 years (48,721 vs 203,246 patients) or because the higher reintervention and secondary rupture rates did not lead to a statistically significant increase in all-cause mortality for EVAR. Subanalysis of older publications showed that EVAR was associated with higher long-term and very

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Fig 2. Meta-analysis of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term all-cause mortality including studies with 5 to 9 years of follow-up. The solid squares are proportional to the weights used in the meta-analysis. The solid vertical line indicates no effect. The horizontal lines represent the 95% confidence interval (CI). The diamond indicates the weighted odds ratio, and the lateral tips of the diamond indicate the associated 95% CI. DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects.

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Fig 3. Meta-analysis of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term all-cause mortality including studies with $10 years of follow-up. The solid squares are proportional to the weights used in the meta-analysis. The solid vertical line indicates no effect. The horizontal lines represent the 95% confidence interval (CI). The diamond indicates the weighted odds ratio, and the lateral tips of the diamond indicate the associated 95% CI. DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; Random, random effects.

long-term all-cause mortality. In contrast, a subanalysis of more recent publications demonstrated no mortality differences between groups despite being adequately powered. Comparison with existing literature. Systematic reviews and meta-analyses on the long-term outcomes of EVAR vs OSR for AAA management have been previously conducted.18,19,21,97 The key strengths of our review include the synthesis of longer follow-up data from more recent studies and inclusion of both randomized and observational studies. Paravastu et al18 published a Cochrane review of RCTs comparing 1243 EVAR and 1241 OSR patients, demonstrating no difference in mortality between groups and a higher long-term (>4 years) reintervention rate for EVAR. Their review was limited by a shorter length of follow-up compared with our study. Furthermore, results from the 15-year follow-up of EVAR-133 and 12-year follow-up of DREAM16 were published after the review was conducted. More recently, Powell et al19 conducted a meta-analysis of individual patient data from the EVAR-1, DREAM, OVER, and Anevrysme de l’aorte abdominale: Chirurgie vs Endoprothese (ACE) trials, which demonstrated no difference in all-cause mortality between EVAR and OSR up to 5 years of follow-up. Our data also showed a similar risk of mortality between techniques and a higher long-term reintervention rate for EVAR when only RCTs were analyzed. We showed that EVAR was associated with higher mortality when both observational studies

and RCTs were included, potentially resulting from a significantly larger sample size. Elsewhere, Takagi et al97 published a systematic review of RCTs and propensity score matched observational studies and pooled >5 year data from survival curves. They included 92,333 patients, and a meta-analysis demonstrated that EVAR was associated with higher mortality between 1.8 and 5 years of follow-up.97 The strength of their work was the synthesis of data from survival curves, allowing for more comprehensive survival analysis. However, the authors excluded important data not reported in the form of survival curves and observational studies that were not propensity score matched. Our study similarly demonstrated that EVAR was associated with higher long-term mortality. Stather et al21 published a systematic review and metaanalysis of RCTs and cohort studies that compared 25,078 EVAR to 27,142 OSR patients and showed no difference in long-term (>4 years) all-cause mortality between groups but higher reintervention and secondary rupture rates for EVAR. Their study was limited by arbitrary study selection criteria, excluding two RCTs because they had <200 patients and six nonrandomized studies because they had <2000 patients, with no clear explanation why these thresholds were chosen.21 Our study similarly demonstrated higher long-term reintervention and secondary rupture rates for EVAR. We also showed that EVAR was associated with higher long-term mortality, potentially due to a larger sample size and inclusion of studies published after 2013.

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Fig 4. Meta-analysis of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term reintervention rate including studies with 5 to 9 years of follow-up. The solid squares are proportional to the weights used in the meta-analysis. The solid vertical line indicates no effect. The horizontal lines represent the 95% confidence interval (CI). The diamond indicates the weighted odds ratio, and the lateral tips of the diamond indicate the associated 95% CI. DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects.

Fig 5. Meta-analysis of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term reintervention rate including studies with $10 years of follow-up. The solid squares are proportional to the weights used in the meta-analysis. The solid vertical line indicates no effect. The horizontal lines represent the 95% confidence interval (CI). The diamond indicates the weighted odds ratio, and the lateral tips of the diamond indicate the associated 95% CI. DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; Random, random effects.

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Fig 6. Meta-analysis of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term secondary rupture rate including studies with 5 to 9 years of follow-up. (Moore 2003 was excluded because there was an event rate of 0% in both groups, leading to a nonestimable odds ratio [OR]). The solid squares are proportional to the weights used in the meta-analysis. The solid vertical line indicates no effect. The horizontal lines represent the 95% confidence interval (CI). The diamond indicates the weighted odds ratio, and the lateral tips of the diamond indicate the associated 95% CI. M-H, Mantel-Haenszel; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects.

Similar to the current literature, our study suggests the lack of survival, reintervention, and secondary rupture benefit of EVAR in the long-term. This systematic review and meta-analysis including all RCTs and observational studies with $5 years of follow-up is currently the largest study on the long-term outcomes of EVAR vs OSR, including important data that have been missed or excluded from previous reviews. Explanation of findings. Early results of RCTs demonstrated improved 30-day mortality for EVAR compared with OSR.5,98 However, longer follow-up showed that the survival advantage was lost over time.7,17 The 15-year follow-up of EVAR-1 demonstrated a higher mortality for EVAR after 8 years,33 and 12-year follow-up of DREAM showed no mortality difference between groups.16 Both trials demonstrated that EVAR was associated with higher reintervention rates at every time point. Large observational studies showed similar findings. Schermerhorn et al14 and Chang et al15 both demonstrated that EVAR lost its survival benefit after 3 years and was associated with higher reintervention and secondary rupture rates up to 8 to 9 years of follow-up. The inferior long-term outcomes of EVAR could be due to its lack of durability. In the short-term, EVAR patients benefit from reduced complications associated with open surgery, such as lower operative mortality and pulmonary complications, less blood loss, and shorter hospitalization.4,5 However, endografts are at higher risk of failure in the long-term due to endoleak, graft migration, kinking, stenosis, and fracture, many of which occur several years postoperatively.8 Le et al99 demonstrated that >30% of endoleaks occur $12 months after EVAR and are associated with more reinterventions than early endoleaks. Zhou et al100 showed that 71% of nontype II endoleaks were diagnosed >1 year postoperatively and increased the rate of reintervention and rupture. Endografts also suffer from migration, which

can lead to sac expansion and rupture.101 Spanos et al102 conducted a systematic review demonstrating that graft migration is generally not identified until 12 to 36 months postoperatively, with 39% requiring reintervention. Of note, the OR magnitude for secondary rupture in our study nearly doubled between 5 to 9 years and $10 years from 4.84 to 8.10. This may have been due to increasing rates of complications, including graft migration and endoleak, leading to sac expansion and secondary rupture over time. Overall, endograft-specific complications can occur late, contribute to frequent reinterventions and adverse outcomes, and ultimately reduce the long-term durability of EVAR. Importantly, reintervention in our review included treatment of access-related complications, such as incisional hernia and bowel obstruction, which occur more frequently after OSR.62 Therefore, the higher reintervention rate of EVAR may be further magnified when considering only graft-related complications. Generally, EVAR complications can be identified and treated effectively with regular follow-up.103 However, <50% of patients adhere to the standard postEVAR follow-up protocol.104 Godfrey et al105 showed that by 4 years after EVAR, only 12.5% of patients undergo regular surveillance. The increasing number of patients lost to follow-up leads to worse survival outcomes, especially in the long-term.106 Cohen et al107 showed that implementing a dedicated surveillance program improved compliance with EVAR follow-up, leading to lower rates of reintervention and aneurysm-related mortality. Furthermore, computed tomography (CT) is the gold standard for diagnosing most EVAR complications but exposes patients to high doses of radiation.108 Prolonged exposure to CT radiation may negatively affect the long-term health of EVAR patients.109,110 Specifically, EVAR-1 demonstrated a higher cancer-related mortality in EVAR patients beyond 8 years of follow-up.33 The cumulative effects of endograft-specific complications, reintervention, secondary rupture, CT radiation,

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and poor follow-up put EVAR patients at a higher risk of death in the long-term.16 This is especially important given that EVAR patients are surviving longer with advances in health care; one-half of the DREAM patients survived >10 years postoperatively.16 Better strategies are needed to maintain consistent long-term endograft surveillance with low doses of radiation. Furthermore, long-term durability should be prioritized by the designers of new EVAR grafts. To assess the outcomes of modern EVAR, we conducted subgroup analysis based on the included studies’ last year of patient recruitment (before or after 2010). Interestingly, when more recent studies were analyzed, there was no longer a mortality difference between groups, suggesting that EVAR outcomes have improved over time. Similarly, Schermerhorn et al14 showed that the 2-year mortality of EVAR decreased from 16.3% in patients who underwent procedures in 2001 to 14.6% in 2007. This improvement was likely due to advancing technique,111 increasing physician expertise,112 and better identification of patients who would benefit from EVAR.71 Furthermore, endovascular devices have been modified over the years, achieving better aneurysm exclusion and durability.113 Reintervention rates, however, remained higher for EVAR in both older and newer studies. This is likely because OSR continues to have very few graft-related complications requiring reintervention, as it is anatomically a more definitive repair of the aneurysmal aorta.114 Another explanation could be that follow-up imaging occurs less frequently after OSR and we may be missing graft-related complications in these patients.115 Kalman et al116 and Hallett et al117 both showed that complications requiring reintervention after OSR may be identified more frequently if surveillance was more rigorous. Despite high rates of endograft-specific complications and frequent reintervention, EVAR is increasingly the preferred method of AAA management, rising from 5.2% to 74% of all surgical treatment of AAA from 2000 to 2010 in the United States.118 Patients also prefer EVAR; Reise et al119 conducted a postal survey demonstrating that 77 of 130 participants (46%) favored EVAR, whereas only 18% favored OSR. The preference for EVAR is likely due to its minimally invasive nature and superior short-term outcomes.120 However, given our results demonstrating the inferior long-term outcomes of EVAR, it is important for both clinicians and patients to consider which treatment strategy is most appropriate, with consideration given to anticipated life expectancy and ability to follow-up.121 Importantly, we demonstrated an improvement in long-term EVAR mortality over time, and others have shown that OSR experience is declining for surgeons.122 We showed no mortality differences between EVAR and OSR when only recent studies were considered. Therefore, the most effective method for modern AAA management remains unclear. However, our results

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suggest that long-term surveillance is critical in EVAR patients given the higher overall risk of death, reintervention, and secondary rupture based on a comprehensive synthesis of the literature. Limitations. This study was limited by high heterogeneity in most of the analyses conducted. This was expected due to the inclusion of many observational studies with varied study populations and data collection and analysis methods. Subgroup analysis of RCTs lowered heterogeneity but also significantly reduced sample size. Therefore, careful interpretation of our results is recommended. Furthermore, several funnel plots demonstrated some evidence of publication bias with missing low-quality studies favoring EVAR, which may have contributed to the overall inferiority of EVAR. However, given that most missing studies were low quality, publication bias was unlikely to have had a significant impact on overall effect size measurements. This study may have also been affected by selection bias due to the inclusion of observational studies that did not statistically adjust for confounding. EVAR and OSR patients may have different baseline characteristics because open procedures are less suitable for patients with a high degree of comorbidity. However, the ranges of baseline covariates were generally comparable between groups. Sensitivity analyses were also conducted to remove studies with a high risk of bias and outliers, which did not have a significant impact on the results. Finally, the inclusion of observational studies is inevitable in a synthesis of all relevant literature on this topic.

CONCLUSIONS This systematic review and meta-analysis presents a contemporary synthesis of the best available evidence on the long-term outcomes of EVAR vs OSR for AAA management. We demonstrate that EVAR is associated with higher long-term all-cause mortality, reintervention, and secondary rupture rates. In the very long-term, EVAR is also associated with higher reintervention and secondary rupture rates. Long-term outcomes of EVAR are inferior to OSR, and vigilant surveillance of EVAR patients is required. Notably, mortality associated with EVAR has improved over time. More studies on newer-generation endografts with longer follow-up are needed to better understand the outcomes of modern EVAR. We thank Teruko Kishibe at the Health Sciences Library of Li Ka Shing Knowledge Institute, St. Michael’s Hospital, University of Toronto, for her help with developing the literature search strategy.

AUTHOR CONTRIBUTIONS Conception and design: BL, SK, KS, MH, CM, EG, BA, TF, SV, MAO Analysis and interpretation: BL, SK, KS

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Data collection: BL, SK, KS Writing the article: BL Critical revision of the article: BL, SK, KS, MH, CM, EG, BA, TF, SV, MAO Final approval of the article: BL, SK, KS, MH, CM, EG, BA, TF, SV, MAO Statistical analysis: BL Obtained funding: Not applicable Overall responsibility: MAO

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undergoing open and endovascular repair of abdominal aortic aneurysm. Asian J Surg 2018;41:490-7. Majd P, Ahmad W, Becker I, Brunkwall JS. Ten-year singlecenter results of abdominal aortic aneurysm treatment: endovascular versus open repair. Ann Vasc Surg 2017;44: 113-8. Martínez Gallego EL, Durán Mariño JL, Pulpeiro Ríos JR, Pena Holguín J, Ruiz Díaz E, García Colodro JM. Impact of endovascular treatment in morbimortality for abdominal aortic aneurysm. Angiologia 2017;69:147-53. Mazzaccaro D, Nano G, Settembrini AM, Carmo M, Dallatana R, Salvati S, et al. Open and endovascular elective treatment of abdominal aortic aneurysms: a real-world experience. Surg Today 2017;47:1347-55. Sugimoto M, Koyama A, Niimi K, Kodama A, Banno H, Komori K. Long-term comparison of endovascular and open repair of abdominal aortic aneurysms: retrospective analysis of matched cohorts with propensity score. Ann Vasc Surg 2017;43:96-103. Yang JH, Kim JW, Choi HC, Park HO, Jang IS, Lee CE, et al. Comparison of clinical outcomes between surgical repair and endovascular stent for the treatment of abdominal aortic aneurysm. Vasc Spec Int 2017;33:140-5. Calvin Alvarez P, Botas Velasco M, Del Canto Peruyera P, Vaquero Lorenzo F, Vallina Victorero MJ, Alvarez Fernandez LJ. Cost of abdominal aortic aneurysm treatment. Open repair compared to endovascular repair. Angiologia 2016;68:20-5. Dunschede F, Aftahy K, Youssef M, Dopheide J, Binder H, Dorweiler B, et al. Propensity score and long-term survival results after open versus endovascular treatment of abdominal aortic aneurysm. Zentralbl Chir 2016;141:518-25. Khashram M, Jenkins JS, Jenkins J, Kruger AJ, Boyne NS, Foster WJ, et al. Long-term outcomes and factors influencing late survival following elective abdominal aortic aneurysm repair: a 24-year experience. Vascular 2016;24: 115-25. Machado R, Antunes IL, Oliveira P, Pereira C, de Almeida R. Institutional impact of EVAR’s incorporation in the treatment of abdominal aortic aneurysm: a 12 years’ experience analysis. Braz J Cardiovasc Surg 2016;31:98-105. Morisaki K, Yamaoka T, Iwasa K, Ohmine T, Guntani A. Preoperative risk factors for aneurysm sac expansion caused by type 2 endoleak after endovascular aneurysm repair. Vascular 2017;25:533-41. Sirignano P, Speziale F, Montelione N, Pranteda C, Galzerano G, Mansour W, et al. Abdominal aortic aneurysm repair: results from a series of young patients. Biomed Res Int 2016;2016:7893413. Yazbek G, Nishinari K, Krutman M, Wolosker N, Zottelle Bomfim GA, Pignataro BS, et al. Treatment of abdominal aortic aneurysms in cancer patients. Ann Vasc Surg 2016;30: 159-65. de Leur K, Flu HC, Ho GH, de Groot HG, Veen EJ, van der Laan L. Outcome of elective treatment of abdominal aortic aneurysm in elderly patients. Int J Surg 2015;15:117-23. Huang Y, Gloviczki P, Oderich GS, Duncan AA, Kalra M, Fleming MD, et al. Outcome after open and endovascular repairs of abdominal aortic aneurysms in matched cohorts using propensity score modeling. J Vasc Surg 2015;62: 304-11.e2. Lee K, Tang E, Dubois L, Power AH, DeRose G, Forbes TL. Durability and survival are similar after elective endovascular and open repair of abdominal aortic aneurysms in younger patients. J Vasc Surg 2015;61:636-41. Saratzis A, Harrison S, Barratt J, Sayers RD, Sarafidis PA, Bown MJ. Intervention associated acute kidney injury and

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78.

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80. Capoccia L, Marino M, Gazzetti M, Biello A, Sbarigia E, Speziale F. Octogenarians submitted to elective infrarenal abdominal aortic aneurysm repair: can they currently be considered “high-risk” for open repair? Ital J Vasc Endovasc Surg 2011;18:57-63. 81. Giles KA, Landon BE, Cotterill P, O’Malley AJ, Pomposelli FB, Schermerhorn ML. Thirty-day mortality and late survival with reinterventions and readmissions after open and endovascular aortic aneurysm repair in Medicare beneficiaries. J Vasc Surg 2011;53:6-11.e2. 82. Quinney BE, Parmar GM, Nagre SB, Patterson M, Passman MA, Taylor S, et al. Long-term single institution comparison of endovascular aneurysm repair and open aortic aneurysm repair. J Vasc Surg 2011;54:1592-8. 83. Cochennec F, Marzelle J, Allaire E, Desgranges P, Becquemin JP. Open vs endovascular repair of abdominal aortic aneurysm involving the iliac bifurcation. J Vasc Surg 2010;51:1360-6. 84. Dias P, Sampaio S, Rocha E Silva A, Roncon de Albuquerque R. The need for reintervention is not higher after EVAR: an eight years single center experience. Rev Port Cir CardiotoracVasc 2010;17:245-50. 85. Jetty P, Hebert P, van Walraven C. Long-term outcomes and resource utilization of endovascular versus open repair of abdominal aortic aneurysms in Ontario. J Vasc Surg 2010;51: 577-83. 583.e1-3. 86. Steinmetz E, Abello N, Kretz B, Gauthier E, Bouchot O, Brenot R. Analysis of outcome after using high-risk criteria selection to surgery versus endovascular repair in the modern era of abdominal aortic aneurysm treatment. Eur J Vasc Endovasc Surg 2010;39:403-9. 87. Mani K, Bjorck M, Lundkvist J, Wanhainen A. Improved longterm survival after abdominal aortic aneurysm repair. Circulation 2009;120:201-11. 88. Berge C, Haug ES, Romundstad PR, Lange C, Myhre HO. Improved long-term survival following infrarenal abdominal aortic aneurysm repair. Scand Cardiovasc J 2008;42: 354-9. 89. Diehm N, Tsoukas AI, Katzen BT, Benenati JF, Baum S, Pena C, et al. Matched-pair analysis of endovascular versus open surgical repair of abdominal aortic aneurysms in young patients at low risk. J Vasc Interv Radiol 2008;19:645-51. 90. Paolini D, Chahwan S, Wojnarowski D, Pigott JP, LaPorte F, Comerota AJ. Elective endovascular and open repair of abdominal aortic aneurysms in octogenarians. J Vasc Surg 2008;47:924-7. 91. Schouten O, Lever TM, Welten GM, Winkel TA, Dols LF, Bax JJ, et al. Long-term cardiac outcome in high-risk patients undergoing elective endovascular or open infrarenal abdominal aortic aneurysm repair. Eur J Vasc Endovasc Surg 2008;36:646-52. 92. Wahlgren CM, Malmstedt J; Swedish Vascular Registry. Outcomes of endovascular abdominal aortic aneurysm repair compared with open surgical repair in high-risk patients: results from the Swedish Vascular Registry. J Vasc Surg 2008;48:1382-9. 93. Aune S, Pedersen G, Laxdal E, Wirshing J, Jensen G, Amundsen S. Has endovascular aneurysm repair improved outcome for patients with asymptomatic abdominal aortic aneurysm? Int Angiol 2007;26:228-32. 94. Chahwan S, Comerota AJ, Pigott JP, Scheuermann BW, Burrow J, Wojnarowski D. Elective treatment of abdominal aortic aneurysm with endovascular or open repair: the first decade. J Vasc Surg 2007;45:258-62; discussion: 262. 95. Mistry PP, Becker P, Van Marle J. A prospective comparison of secondary interventions and mortality in open and

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radiation exposure, and associated radiation-induced cancer risks from CT of adults. Radiology 2009;251:175-84. Fazel R, Krumholz HM, Wang Y, Ross JS, Chen J, Ting HH, et al. Exposure to low-dose ionizing radiation from medical imaging procedures. N Engl J Med 2009;361:849-57. England A, Mc Williams R. Endovascular aortic aneurysm repair (EVAR). Ulster Med J 2013;82:3-10. Hurks R, Ultee KH, Buck DB, DaSilva GS, Soden PA, van Herwaarden JA, et al. The impact of endovascular repair on specialties performing abdominal aortic aneurysm repair. J Vasc Surg 2015;62:562-8.e3. Eckroth-Bernard K, Garvin R, Ryer E. Current status of endovascular devices to treat abdominal aortic aneurysms. Biomed Eng Comput Biol 2013;5:25-32. Biancari F, Ylönen K, Anttila V, Juvonen J, Romsi P, Satta J, et al. Durability of open repair of infrarenal abdominal aortic aneurysm: a 15-year follow-up study. J Vasc Surg 2002;35:87-93. Piffaretti G, Mariscalco G, Riva F, Fontana F, Carrafiello G, Castelli P. Abdominal aortic aneurysm repair: long-term follow-up of endovascular versus open repair. Arch Med Sci 2014;10:273-82. Kalman PG, Rappaport DC, Merchant N, Clarke K, Johnston KW. The value of late computed tomographic scanning in identification of vascular abnormalities after abdominal aortic aneurysm repair. J Vasc Surg 1999;29: 442-50. Hallett JW, Marshall DM, Petterson TM, Gray DT, Bower TC, Cherry KJ, et al. Graft-related complications after abdominal aortic aneurysm repair: reassurance from a 36-year population-based experience. J Vasc Surg 1997;25:277-86. Dua A, Kuy S, Lee CJ, Upchurch GR, Desai SS. Epidemiology of aortic aneurysm repair in the United States from 2000 to 2010. J Vasc Surg 2014;59:1512-7. 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. Winterborn RJ, Amin I, Lyratzopoulos G, Walker N, Varty K, Campbell WB. Preferences for endovascular (EVAR) or open surgical repair among patients with abdominal aortic aneurysms under surveillance. J Vasc Surg 2009;49:576-81.e3. Al-Omran M, Verma S, Lindsay TF, Weisel RD, Sternbach Y. Clinical decision making for endovascular repair of abdominal aortic aneurysm. Circulation 2004;110:e517-23. Dua A, Upchurch GR, Lee JT, Eidt J, Desai SS. Predicted shortfall in open aneurysm experience for vascular surgery trainees. J Vasc Surg 2014;60:945-9.

Submitted Oct 26, 2018; accepted Jan 11, 2019.

Additional material for this article may be found online at www.jvascsurg.org.

Journal of Vascular Surgery Volume

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Supplementary Table I (online only). A, Detailed literature search strategy for MEDLINE Database: Epub Ahead of Print, In-Process and Other Non-Indexed Citations, Ovid MEDLINE Daily, and Ovid MEDLINE (1946 to May 8, 2018) Search strategy 1 Aortic Aneurysm, Abdominal/ (17052) 2 (aneurysm* adj5 (abdom* or thoracoabdom*)).tw,kf. (21026) 3 (AAA or AAAs).tw,kf. (12908) 4 1 or 2 or 3 (31076) 5 Endovascular Procedures/ (12888) 6 Blood Vessel Prosthesis/ (27255) 7 Blood Vessel Prosthesis Implantation/ (20392) 8 endovascular*.tw,kf. (41673) 9 EVAR.tw,kf. (3297) 10 EVRAR.tw,kf. (3) 11 TEVAR.tw,kf. (1314) 12 prosthes?s.tw,kf. (78890) 13 endoprosthes?s.tw,kf. (5789) 14 graft*.tw,kf. (299957) 15 endograft*.tw,kf. (3013) 16 stent*.tw,kf. (88637) 17 endostent*.tw,kf. (34) 18 percutaneous.tw,kf. (126451) 19 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 or 17 or 18 (583575) 20 open.tw,kf. (430792) 21 OSR.tw,kf. (481) 22 OAS.tw,kf. (1815) 23 OAR.tw,kf. (1776) 24 20 or 21 or 22 or 23 (434523) 25 4 and 19 and 24 (3662) 26 exp Animals/ not Humans/ (4453410) 27 25 not 26 (3650) 28 limit 27 to (case reports or comment or editorial or letter) (665) 29 27 not 28 (2985)

16.e2

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Supplementary Table I (online only). B, Detailed literature search strategy for Embase Classic and Embase (1947 to May 7, 2018) Search strategy 1 abdominal aortic aneurysm/ (1677) 2 (aneurysm* adj5 (abdom* or thoracoabdom*)).tw,kw. (27307) 3 (AAA or AAAs).tw,kw. (16692) 4 1 or 2 or 3 (35198) 5 endovascular aneurysm repair/ (9353) 6 endovascular*.tw,kw. (62065) 7 EVAR.tw,kw. (5030) 8 EVRAR.tw,kw. (4) 9 TEVAR.tw,kw. (2074) 10 prosthes?s.tw,kw. (100652) 11 endoprosthes?s.tw,kw. (7374) 12 graft*.tw,kw. (420936) 13 endograft*.tw,kw. (4136) 14 stent*.tw,kw. (147346) 15 endostent*.tw,kw. (51) 16 percutaneous.tw,kw. (192991) 17 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 or 15 or 16 (821181) 18 open.tw,kw. (564595) 19 OSR.tw,kw. (655) 20 OAS.tw,kw. (2779) 21 OAR.tw,kw. (4668) 22 18 or 19 or 20 or 21 (572142) 23 4 and 17 and 22 (4599) 24 (exp animal/ or nonhuman/) not exp human/ (6605322) 25 23 not 24 (4567) 26 case report/ (2331157) 27 editorial/ (578198) 28 letter/ (969565) 29 26 or 27 or 28 (3680077) 30 25 not 29 (3877) 31 limit 30 to embase (2624)

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Supplementary Table I (online only). C, Detailed literature search strategy for Evidence Based Medicine Reviews e Cochrane Central Register of Controlled Trials (Inception to May 2018) Search strategy 1 (aneurysm* adj5 (abdom* or thoracoabdom*)).tw,hw. (963) 2 (AAA or AAAs).tw,hw. (464) 3 1 or 2 (1063) 4 endovascular*.tw,hw. (2198) 5 EVAR.tw,hw. (191) 6 EVRAR.tw,hw. (0) 7 TEVAR.tw,hw. (43) 8 prosthes?s.tw,hw. (10374) 9 endoprosthes?s.tw,hw. (256) 10 graft*.tw,hw. (20491) 11 endograft*.tw,hw. (103) 12 stent*.tw,hw. (9681) 13 endostent*.tw,hw. (1) 14 percutaneous.tw,hw. (12588) 15 4 or 5 or 6 or 7 or 8 or 9 or 10 or 11 or 12 or 13 or 14 (47018) 16 open.tw,kw. (60664) 17 OSR.tw,kw. (80) 18 OAS.tw,kw. (160) 19 OAR.tw,kw. (121) 20 16 or 17 or 18 or 19 (60966) 21 3 and 15 and 20 (245)

16.e4

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Supplementary Table II (online only). Baseline demographic and clinical characteristicsa Demographics

Study

Comorbidities

Medications

be AAA Age, Male, diameter, HTN, DLP, DM, Smoker, CAD, CVD, COPD, CKD, Antiplatelet, Anticoagulant, Blocker, Statin, % % years % cm % % % % % % % % % %

DREAM EVAR

71

93

6.1

58

47

10

64

41

e

e

8

41

12

44

37

70

90

6.0

55

53

10

55

47

e

e

8

40

15

51

42

EVAR

74

90

6.4

e

e

61

88

43

e

e

e

54

e

e

35

OSR

74

91

6.5

e

e

68

93

42

e

e

e

52

e

e

36

70

99

5.7

78

e

23

96

39

15

28

32

55

10

64

e

71

100

5.7

76

e

23

95

42

16

30

31

64

8

65

e

OSR EVARe1

OVER EVAR OSR Antonello EVAR

72

94

e

79

31

35

73

53

14

47

e

e

e

e

e

OSR

72

82

e

81

31

28

63

34

11

20

e

e

e

e

e

EVAR

73

87

5.6

e

49

e

e

e

e

e

e

e

e

e

e

OSR

70

74

5.9

e

38

e

e

e

e

e

e

e

e

e

e

EVAR

71

94

5.2

56

26

11

19

28

e

28

12

e

e

e

e

OSR

69

94

5.4

55

24

8

28

34

e

23

13

e

e

e

e

EVAR

67

90

5.3

65

15

10

35

50

e

50

20

e

e

e

e

OSR

66

90

5.2

85

60

15

25

70

e

15

10

e

e

e

e

EVAR

73

94

5.2

66

35

9

e

46

14

56

11

e

e

e

e

OSR

72

90

5.6

66

30

7

e

37

10

38

10

e

e

e

e

Peterson

Goueffic

Torsello

Cao

Moore EVAR

75

94

5.6

56

e

7

80

70

24

28

4

e

e

e

e

OSR

73

86

5.9

66

e

10

79

59

23

18

10

e

e

e

e

EVAR

74

79

5.8

77

59

20

74

53

e

31

13

e

e

e

e

OSR

69

63

5.9

65

45

10

62

44

e

28

22

e

e

e

e

EVAR

76

79

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

73

74

e

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

83

87

5.7

90

e

8

37

39

13

21

42

e

e

e

e

OSR

82

76

6.0

89

e

4

52

38

9

20

48

e

e

e

e

Chandra

Chiang

Majd

O’Donnell EVAR

74

81

5.5

83

e

21

86

30

e

33

34

68

e

57

e

OSR

70

74

5.7

84

e

16

86

27

e

33

33

68

e

64

e

Bae EVAR

71

81

6.1

69

16

7

66

21

19

2

9

e

e

e

e

OSR

67

63

6.4

68

5

13

55

23

5

3

10

e

e

e

e

EVAR

74

85

e

70

39

17

e

34

2

15

2

e

e

e

e

OSR

71

83

e

70

36

15

e

35

2

16

3

e

e

e

e

75

75

5.9

83

38

25

8

31

9

21

10

4

53

53

Behrendt

Chinsakchai EVAR

35

Journal of Vascular Surgery Volume

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Number

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Supplementary Table II (online only). Continued. Demographics

Study OSR

Comorbidities

Medications

be AAA Age, Male, diameter, HTN, DLP, DM, Smoker, CAD, CVD, COPD, CKD, Antiplatelet, Anticoagulant, Blocker, Statin, % % years % cm % % % % % % % % % % 69

80

6.3

76

49

10

24

20

10

11

9

EVAR

75

e

e

e

e

e

e

e

e

e

e

OSR

70

e

e

e

e

e

e

e

e

e

e

EVAR

e

e

e

e

e

e

e

e

e

e

OSR

e

e

e

e

e

e

e

e

e

e

EVAR

72

98

6.0

89

51

7

57

52

e

OSR

72

98

5.9

89

57

9

57

52

e

EVAR

76

94

e

70

58

24

51

73

OSR

68

97

e

51

60

25

52

23

33

3

56

50

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

22

26

e

e

e

e

22

26

e

e

e

e

e

29

12

e

e

e

e

e

25

6

e

e

e

e

Laine

Law

Majd

Martinez Gallego

Mazzaccaro EVAR

73

93

5.3

25

11

4

61

8

e

5

6

89

4

7

8

OSR

71

89

5.1

63

73

12

65

8

e

26

12

85

4

7

40

Sugimoto EVAR

75

87

5.3

68

e

13

e

33

13

10

2

e

e

e

e

OSR

74

86

5.3

73

e

10

e

35

11

10

2

e

e

e

e

Yang EVAR

73

87

6.1

55

e

6

53

47

9

15

11

36

2

e

26

OSR

66

85

6.7

61

e

20

70

39

7

17

7

24

4

e

11

Calvin Alvarez EVAR

75

91

e

85

47

9

21

41

e

24

15

e

e

e

e

OSR

71

98

e

70

63

15

18

15

e

13

20

e

e

e

e

EVAR

75

88

e

e

e

13

e

4

2

18

10

e

e

e

e

OSR

72

85

e

e

e

8

e

6

2

13

7

e

e

e

e

Desai

Dunschede EVAR

70

91

e

e

e

13

e

43

6

7

15

e

e

e

e

OSR

70

90

e

e

e

10

e

51

8

10

15

e

e

e

e

Khashram EVAR

73

91

5.5

75

58

19

91

e

15

24

12

e

e

e

e

OSR

72

78

5.8

72

41

11

90

e

13

29

8

e

e

e

e

EVAR

74

94

6.2

84

68

18

75

53

19

24

21

e

e

e

e

OSR

70

95

6.5

87

61

11

89

40

11

27

9

e

e

e

e

EVAR

84

68

5.4

77

e

19

e

33

14

15

15

36

e

e

23

OSR

83

64

5.4

84

e

19

e

36

7

7

10

46

e

e

34

EVAR

57

96

e

59

53

13

67

22

e

14

16

e

e

e

e

OSR

56

97

e

73

41

16

80

31

e

11

17

e

e

e

e

EVAR

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

Machado

Morisaki

Sirignano

Yazbek

Chang

(Continued on next page)

16.e6

Journal of Vascular Surgery

Li et al

---

2019

Supplementary Table II (online only). Continued. Demographics

Study

Comorbidities

Medications

be AAA Age, Male, diameter, HTN, DLP, DM, Smoker, CAD, CVD, COPD, CKD, Antiplatelet, Anticoagulant, Blocker, Statin, % % years % cm % % % % % % % % % %

EVAR

75

84

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

72

78

e

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

74

86

5.7

e

e

e

e

e

e

e

e

e

e

e

e

OSR

72

86

5.9

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

57

92

e

86

72

28

82

30

e

24

8

e

e

e

e

OSR

57

92

e

69

59

23

90

24

e

21

8

e

e

e

e

de Leur

Huang

Lee

Saratzis EVAR

71

93

e

67

26

14

74

19

9

7

18

98

e

14

54

OSR

71

83

e

65

28

4

60

24

12

5

16

100

e

21

58

EVAR

76

78

e

63

e

16

e

8

14

28

6

e

e

e

e

OSR

76

78

e

63

e

16

e

8

14

28

6

e

e

e

e

Schermerhorn

Thomas EVAR

e

e

e

56

35

17

48

e

e

e

9

e

e

e

e

OSR

e

e

e

48

30

15

28

e

e

e

13

e

e

e

e

Yamamoto EVAR

78

83

5.3

71

41

11

e

33

16

14

4

e

e

e

e

OSR

71

85

5.3

75

45

45

e

33

10

8

5

e

e

e

e

Kovacs EVAR

73

95

e

81

24

10

e

36

e

e

e

e

e

e

e

OSR

69

85

e

77

17

17

e

39

e

e

e

e

e

e

e

Pane EVAR

77

92

e

77

28

8

84

e

e

36

26

e

e

e

e

OSR

75

85

e

69

30

9

81

e

e

30

26

e

e

e

e

EVAR

61

95

6.4

58

44

12

86

e

e

e

5

e

e

e

e

OSR

62

93

6.6

46

27

5

67

e

e

e

0

e

e

e

e

Sandford

Al-Jubouri EVAR

74

41

5.5

77

55

6

70

54

e

41

7

e

e

e

e

OSR

72

38

5.5

74

50

3

73

45

e

40

14

e

e

e

e

EVAR

62

e

e

63

e

13

74

66

e

45

22

e

e

e

e

OSR

63

e

e

50

e

7

44

39

e

10

3

e

e

e

e

EVAR

73

79

5.4

84

e

21

86

35

e

34

35

73

e

76

70

OSR

69

73

5.3

82

e

15

93

31

e

34

34

73

e

85

67

EVAR

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

e

e

e

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

75

100

5.3

88

35

6

e

12

12

24

e

e

e

e

e

OSR

71

87

5.8

80

49

13

e

44

14

14

e

e

e

e

e

Altaf

De Martino

Goodyear

Ito

Journal of Vascular Surgery Volume

-,

Number

Li et al

16.e7

-

Supplementary Table II (online only). Continued. Demographics

Study

Comorbidities

Medications

be AAA Age, Male, diameter, HTN, DLP, DM, Smoker, CAD, CVD, COPD, CKD, Antiplatelet, Anticoagulant, Blocker, Statin, % % years % cm % % % % % % % % % %

Lee EVAR

72

81

e

54

65

12

88

e

13

19

e

64

12

e

e

OSR

73

84

e

56

62

11

91

e

13

18

e

60

11

e

e

Mark EVAR

e

85

e

e

e

15

e

e

e

29

7

e

e

e

e

OSR

e

84

e

e

e

14

e

e

e

31

7

e

e

e

e

EVAR

71

84

e

69

46

15

26

56

11

24

3

e

e

e

e

OSR

69

77

e

60

28

5

25

45

11

22

3

e

e

e

e

EVAR

71

93

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

69

91

e

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

76

80

e

59

e

19

e

e

e

24

3

e

e

e

e

OSR

75

71

e

54

e

15

e

e

e

25

4

e

e

e

e

Mujib

Hinterseher

Jackson

Min EVAR

76

92

e

73

19

19

73

42

12

23

8

e

e

e

e

OSR

70

86

e

76

17

6

74

27

17

18

9

e

e

e

e

EVAR

67

81

e

45

e

7

27

30

14

e

e

e

e

e

e

OSR

69

76

e

52

e

9

25

24

8

e

e

e

e

e

e

Ren

Capoccia EVAR

83

86

5.6

90

14

10

90

55

e

38

34

e

e

e

e

OSR

82

70

6.4

70

17

13

57

38

e

34

32

e

e

e

e

EVAR

76

80

e

66

e

16

e

10

16

30

4

e

e

e

e

OSR

76

81

e

66

e

16

e

10

16

30

4

e

e

e

e

EVAR

e

85

e

70

46

15

84

55

e

24

e

e

e

e

e

OSR

e

82

e

59

28

9

62

44

e

22

e

e

e

e

e

EVAR

72

96

5.6

44

31

13

50

35

e

21

15

e

e

e

e

OSR

64

95

5.5

40

22

13

36

30

e

10

6

e

e

e

e

EVAR

75

94

e

e

e

e

e

e

e

e

e

e

e

e

e

OSR

69

94

e

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

76

86

e

73

e

24

e

42

14

34

6

e

e

e

e

OSR

72

80

e

61

e

18

e

29

10

22

3

e

e

e

e

Giles

Quinney

Cochennec

Dias

Jetty

Steinmetz EVAR

78

93

5.8

71

47

17

79

68

14

24

28

e

e

e

e

OSR

76

86

5.8

72

55

13

75

50

14

25

22

e

e

e

e

EVAR

74

86

e

e

e

e

e

58

e

19

14

e

e

e

e

OSR

71

81

e

e

e

e

e

53

e

18

10

e

e

e

e

71

88

56

e

9

46

44

15

13

13

e

e

e

e

Mani

Berge EVAR

e

(Continued on next page)

16.e8

Journal of Vascular Surgery

Li et al

---

2019

Supplementary Table II (online only). Continued. Demographics

Study OSR

Comorbidities

Medications

be AAA Age, Male, diameter, HTN, DLP, DM, Smoker, CAD, CVD, COPD, CKD, Antiplatelet, Anticoagulant, Blocker, Statin, % % years % cm % % % % % % % % % % 71

84

e

45

e

6

50

48

16

13

9

e

e

e

e

Diehm EVAR

62

92

5.0

56

44

20

92

e

4

24

e

36

e

24

40

OSR

59

92

5.5

76

60

12

80

e

4

24

e

40

e

20

32

Paolini EVAR

84

70

5.8

69

e

e

64

52

e

15

e

e

e

e

e

OSR

83

70

6.2

74

e

e

67

46

e

38

e

e

e

e

e

Schouten EVAR

74

91

e

36

e

14

e

84

30

36

25

71

e

86

67

OSR

74

93

e

46

e

15

e

87

42

41

20

73

e

87

59

EVAR

74

86

e

61

38

13

35

59

16

20

15

e

e

e

17

OSR

71

82

e

62

43

8

50

53

14

19

10

e

e

e

14

EVAR

74

92

e

42

e

14

e

61

e

20

11

e

e

e

e

OSR

72

83

e

47

e

6

e

51

e

14

13

e

e

e

e

EVAR

74

80

5.5

69

e

e

86

54

e

19

e

e

e

e

e

OSR

72

78

6.0

70

e

e

86

49

e

41

e

e

e

e

e

Wahlgren

Aune

Chahwan

Mistry EVAR

66

96

5.7

e

e

e

e

e

e

e

e

e

e

e

e

OSR

66

89

5.7

e

e

e

e

e

e

e

e

e

e

e

e

EVAR

73

92

e

63

e

11

82

57

9

26

5

e

e

e

e

OSR

72

77

e

71

e

10

90

61

12

30

5

e

e

e

e

Moore

AAA, Abdominal aortic aneurysm; CAD, coronary artery disease; CKD: chronic kidney disease; COPD, chronic obstructive pulmonary disease; CVD, cerebrovascular disease; DLP, dyslipidemia; DM, diabetes mellitus; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR, endovascular aneurysm repair; EVAR-1, United Kingdom Endovascular Aneurysm Repair Trial 1; HTN, hypertension; OSR, open surgical repair; Smoker, former or current smoker; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study. a All values are expressed as proportions (%), except age and AAA diameter, which are reported as means. The dash (e) represents values that were not reported, could not be calculated from reported data, and authors were not able to provide.

Journal of Vascular Surgery Volume

-,

Number

Li et al

16.e9

-

Supplementary Table III (online only). Quality assessment of included studies

RCTsa

Random sequence generation

Allocation concealment

Blinding of participants and personnel

Blinding of outcome assessment

Incomplete outcome data

Selective reporting

Other bias

Risk of bias

DREAM

Low

Low

Unclear

Low

Low

Low

Low

Low

EVAR-1

Low

Low

Unclear

Low

Low

Low

Low

Low

OVER

Low

Low

Unclear

Low

Low

Low

Low

Low

Representativeness of exposed cohort

Selection of nonexposed cohort

Ascertainment of exposure

Absence of outcome at start of study

Antonello

1

1

1

1

0

1

1

1

7

Peterson

1

1

1

1

0

1

1

0

6

Goueffic

1

1

1

1

0

1

1

1

7

Torsello

1

1

1

1

0

1

1

0

6

Observational studiesb

Comparability of cohorts

Outcome assessment

Length of follow-up

Adequacy of follow-up

NOS score

Cao

1

1

1

1

0

1

1

1

7

Moore

1

1

1

1

0

1

1

0

6

Chandra Chiang Majd

0

1

1

1

2

1

1

0

7

1

1

1

1

0

1

1

0

6

0

1

1

1

0

1

1

0

5

O’Donnell

1

1

1

1

2

1

1

0

8

Bae

1

1

1

1

0

1

1

0

6

Behrendt

1

1

1

1

1

1

1

1

8

Chinsakchai

1

1

1

1

0

1

1

0

6

Laine

1

1

1

1

1

1

1

1

8

Law

0

1

1

1

1

1

1

0

6

Majd

1

1

1

1

2

1

1

1

9

Martinez Gallego

1

1

1

1

0

1

1

0

6

Mazzaccaro

1

1

1

1

1

1

1

0

7

Sugimoto

1

1

1

1

2

1

1

0

8

Yang

1

1

1

1

1

1

1

0

7

Calvin Alvarez

1

1

1

1

1

1

1

0

7

Desai

1

1

1

1

1

1

1

0

7 8

Dunschede

0

1

1

1

2

1

1

1

Khashram

1

1

1

1

1

1

1

0

7

Machado

1

1

1

1

0

1

1

0

6

Morisaki

0

1

1

1

0

1

1

0

5

Sirignano

1

1

1

1

0

1

1

0

6

Yazbek

0

1

1

1

0

1

1

0

5

Chang

1

1

1

1

1

1

1

1

8

de Leur

1

1

1

1

0

1

1

0

6

Huang

1

1

1

1

2

1

1

0

8

Lee

1

1

1

1

0

1

1

0

6

Saratzis

1

1

1

1

2

1

1

0

8

Schermerhorn

1

1

1

1

2

1

1

0

8

Thomas

1

1

1

1

0

1

1

0

6

0

1

1

1

0

1

1

1

6

1

1

1

1

1

1

1

0

7

Pane

0

1

1

1

1

1

1

0

6

Sandford

0

1

1

1

0

1

1

0

5

Al-Jubouri

1

1

1

1

1

1

1

0

7

Altaf

0

1

1

1

1

1

1

0

6

De Martino

0

1

1

1

1

1

1

1

7

1

1

1

1

0

1

1

0

6

0

1

1

1

0

0

1

0

4

Yamamoto Kovacs

Goodyear Ito

(Continued on next page)

16.e10

Journal of Vascular Surgery

Li et al

---

2019

Supplementary Table III (online only). Continued.

Observational studiesb

Representativeness of exposed cohort

Lee

Selection of nonexposed cohort

Ascertainment of exposure

Absence of outcome at start of study

Comparability of cohorts

Outcome assessment

Length of follow-up

Adequacy of follow-up

NOS score 8

1

1

1

1

2

1

1

0

Mark

0

0

1

1

2

1

1

0

6

Mujib

1

1

1

1

0

1

1

0

6

Hinterseher

1

1

1

1

0

1

1

0

6

Jackson

1

1

1

1

2

1

1

1

9

Min

1

1

1

1

0

1

1

1

7

Ren

1

1

1

1

0

1

1

1

7

0

1

1

1

0

1

1

0

5

Giles

1

1

1

1

2

1

1

0

8

Quinney

1

1

1

1

0

1

1

0

6

0

1

1

1

0

1

1

1

6

1

1

1

1

0

1

1

0

6

Capoccia

Cochennec Dias Jetty

1

1

1

1

1

1

1

0

7

0

1

1

1

0

1

1

0

5

Mani

1

1

1

1

0

1

1

0

6

Berge

1

1

1

1

1

1

1

1

8

Diehm

0

1

1

1

2

1

1

0

7

Paolini

0

1

1

1

0

1

1

0

5

Schouten

0

1

1

1

1

1

1

0

6

Wahlgren

1

1

1

1

1

1

1

0

7

Aune

1

1

1

1

0

1

1

0

6

Steinmetz

Chahwan

1

1

1

1

1

1

1

0

7

Mistry

1

1

1

1

1

1

1

0

7

Moore

1

1

1

1

2

1

1

1

9

DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR-1, United Kingdom Endovascular Aneurysm Repair Trial 1; NOS, NewcastleOttawa Scale; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; RCTs, randomized controlled trials. a RCTs were assessed using the Cochrane Collaboration risk of bias tool. An assessment of low risk, high risk, or unclear is given to each category and overall study. b Observational studies were assessed using the NOS. A maximum of 1 point is awarded per category, except for comparability of cohorts, where a maximum of 2 points can be awarded. An overall maximum score of 9 can be awarded per study. NOS score $8 is low risk, 6 to 7 is moderate risk, and #5 is high risk.

0 SE(log[OR])

0.2

0.4

0.6

0.8

1 0.01

0.1

1

10

OR 100

Supplementary Fig 1 (online only). Funnel plot of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term all-cause mortality including studies with 5 to 9 years of follow-up. OR, odds ratio; SE, standard error.

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 2 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) longterm all-cause mortality including studies with 5 to 9 years of follow-up, excluding 9 studies with high risk of bias based on study quality assessment (Capoccia 2011, Ito 2013, Majd 2018, Morisaki 2016, Pane 2014, Paolini 2008, Schouten 2008, Steinmetz 2010, and Yazbek 2016). A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects; SE, standard error.

16.e11

16.e12

Journal of Vascular Surgery

Li et al

---

B SE(log[OR]) 0

0.2

0.4

0.6

0.8

1 0.01

0.1

1

10

Supplementary Fig 2 (online only). Continued.

OR 100

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 3 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term all-cause mortality including randomized controlled trials (RCTs) with 5 to 9 years of follow-up. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; SE, standard error.

16.e13

16.e14

Li et al

Journal of Vascular Surgery ---

Supplementary Fig 4 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) longterm all-cause mortality including studies with 5 to 9 years of follow-up with last year of patient recruitment before 2010. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects; SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

B SE(log[OR]) 0

0.2

0.4

0.6

0.8

1 0.01

0.1

1

10

Supplementary Fig 4 (online only). Continued.

OR 100

16.e15

16.e16

Li et al

Journal of Vascular Surgery ---

Supplementary Fig 5 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) longterm all-cause mortality including studies with 5 to 9 years of follow-up with last year of patient recruitment 2010 or after. A, Meta-analysis. B, Funnel plot. CI, Confidence interval, M-H, Mantel-Haenszel; OR, odds ratio; Random, random effects; SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

0 SE(log[OR])

0.1

0.2

0.3

0.4

0.5 0.01

0.1

1

10

OR 100

Supplementary Fig 6 (online only). Funnel plot of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term all-cause mortality including studies with $10 years of follow-up. OR, Odds ratio; SE, standard error.

16.e17

16.e18

Li et al

Journal of Vascular Surgery ---

Supplementary Fig 7 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term all-cause mortality including randomized controlled trials (RCTs) with $10 years of follow-up. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 8 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very longterm all-cause mortality including studies with $10 years of follow-up with last year of patient recruitment before 2010. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; Random: random effects; SE, standard error.

16.e19

16.e20

Li et al

Journal of Vascular Surgery ---

Supplementary Fig 9 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very longterm all-cause mortality including studies with $10 years of follow-up with last year of patient recruitment 2010 or after. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; M-H, Mantel-Haenszel; OR, odds ratio; Random, random effects; SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

0 SE(log[OR])

0.5

1

1.5

2 0.01

0.1

1

10

OR 100

Supplementary Fig 10 (online only). Funnel plot of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term reintervention rate including studies with 5 to 9 years of follow-up. OR, odds ratio; SE, standard error.

Supplementary Fig 11 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) longterm reintervention rate including studies with 5 to 9 years of follow up and excluding studies with a high risk of bias according to study quality assessment (Morisaki 2016, Sandford 2014) and outlier (Yang 2017). A, Metaanalysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects; SE, standard error.

16.e21

16.e22

Journal of Vascular Surgery

Li et al

---

B SE(log[OR]) 0

0.5

1

1.5

2 0.01

0.1

1

10

Supplementary Fig 11 (online only). Continued.

OR 100

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 12 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term reintervention rate including randomized controlled trials (RCTs) with 5 to 9 years of follow-up. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects; SE, standard error.

16.e23

16.e24

Li et al

Journal of Vascular Surgery ---

Supplementary Fig 13 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) longterm reintervention rate including studies with 5 to 9 years of follow-up with last year of patient recruitment before 2010. A, Meta-analysis. B, Funnel plot. DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; OVER, Open versus Endovascular Repair Veterans Affairs Cooperative Study; Random, random effects; SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 14 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) longterm reintervention rate including studies with 5 to 9 years of follow-up with last year of patient recruitment 2010 or after. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; M-H, Mantel-Haenszel; OR, odds ratio; Random, random effects; SE, standard error.

16.e25

16.e26

Journal of Vascular Surgery

Li et al

---

0 SE(log[OR])

0.2

0.4

0.6

0.8

1 0.01

0.1

1

10

OR 100

Supplementary Fig 15 (online only). Funnel plot of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term reintervention rate including studies with $10 years of follow-up. OR, odds ratio; SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 16 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term reintervention rate including randomized controlled trials (RCTs) with $10 years of follow-up. A, Metaanalysis. B, Funnel plot. CI, Confidence interval, DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; Random, random effects; SE, standard error.

16.e27

16.e28

Li et al

Journal of Vascular Surgery ---

Supplementary Fig 17 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term reintervention rate including studies with $10 years of follow-up with last year of patient recruitment before 2010. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; DREAM, Dutch Randomised Endovascular Aneurysm Management; EVAR 1, United Kingdom Endovascular Aneurysm Repair Trial 1; M-H, Mantel-Haenszel; OR, odds ratio; Random, random effects; SE, standard error.

2019

Journal of Vascular Surgery Volume

-,

Number

Li et al

-

Supplementary Fig 18 (online only). Endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) very long-term reintervention rate including studies with $10 years of follow-up with last year of patient recruitment 2010 or after. A, Meta-analysis. B, Funnel plot. CI, Confidence interval; M-H, Mantel-Haenszel; OR, odds ratio; Random, random effects; SE, standard error.

16.e29

16.e30

Journal of Vascular Surgery

Li et al

---

0

SE(log[OR])

0.5

1

1.5

2 0.01

0.1

1

10

OR 100

Supplementary Fig 19 (online only). Funnel plot of endovascular aneurysm repair (EVAR) vs open surgical repair (OSR) long-term secondary rupture rate including studies with 5 to 9 years of follow-up (Moore 2003 was excluded because there was an event rate of 0% in both groups, leading to a nonestimable odds ratio). OR, odds ratio; SE, standard error.

2019