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ORIGINAL CONTRIBUTION
Outcomes Following Endovascular vs
Open Repair of Abdominal Aortic Aneurysm
A Randomized Trial
Frank A. Lederle, MD
Julie A. Freischlag, MD
Tassos C. Kyriakides, PhD
Frank T. Padberg Jr, MD
Jon S. Matsumura, MD
Ted R. Kohler, MD
Peter H. Lin, MD
Jessie M. Jean-Claude, MD
Dolores F. Cikrit, MD
Kathleen M. Swanson, MS, RPh
Peter N. Peduzzi, PhD
for the Open Versus Endovascular
Repair (OVER) Veterans Affairs
Cooperative Study Group
EACH YEAR IN THE UNITED STATES,
45 000 patients with unrup-
tured abdominal aortic aneu-
rysm (AAA) undergo elective re-
pair, resulting in more than 1400
perioperative deaths.1Endovascular re-
pair was developed to provide a less in-
vasive method than the standard open
procedure and has been reported to re-
duce perioperative mortality, hospital
stay, and intensive care unit (ICU) stay.
However, more frequent reinterven-
tions have also been reported and the
early survival advantage was lost within
2 years in previous randomized trials
conducted in Europe,2-4 leaving the pre-
ferred approach for AAA repair in doubt.
Furthermore, the relative effects of the
2 procedures on quality of life and erec-
tile function remain unclear.
Devices and techniques continue to
improve and operative mortalities and
morbidities were relatively high in the
European trials, raising the question of
how relevant their results are to cur-
rent US practice. We report short-
term perioperative outcomes after elec-
tive endovascular and open repair of
AAA from a US multicenter random-
ized trial.
METHODS
Study Oversight
The study was approved by a central
human rights committee and the insti-
tutional review boards at each partici-
pating center. An independent data
monitoring committee reviewed the
data at regular intervals.
Patients
Eligible patients had AAA for which re-
pair was planned and had (1) a maxi-
Author Affiliations and Open Versus Endovascular
Repair (OVER) Veterans Affairs Cooperative Study
Group are listed at the end of this article.
Corresponding Author: Frank A. Lederle, MD, De-
partment of Medicine (III-0), Veterans Affairs Medi-
cal Center, 1 Veterans Dr, Minneapolis, MN 55417
(frank.lederle@va.gov).
Context Limited data are available to assess whether endovascular repair of abdomi-
nal aortic aneurysm (AAA) improves short-term outcomes compared with traditional
open repair.
Objective To compare postoperative outcomes up to 2 years after endovascular or
open repair of AAA in a planned interim report of a 9-year trial.
Design, Setting, and Patients A randomized, multicenter clinical trial of 881 vet-
erans (aged ⱖ49 years) from 42 Veterans Affairs Medical Centers with eligible AAA
who were candidates for both elective endovascular repair and open repair of AAA.
The trial is ongoing and this report describes the period between October 15, 2002,
and October 15, 2008.
Intervention Elective endovascular (n=444) or open (n= 437) repair of AAA.
Main Outcome Measures Procedure failure, secondary therapeutic procedures,
length of stay, quality of life, erectile dysfunction, major morbidity, and mortality.
Results Mean follow-up was 1.8 years. Perioperative mortality (30 days or inpa-
tient) was lower for endovascular repair (0.5% vs 3.0%; P=.004), but there was no
significant difference in mortality at 2 years (7.0% vs 9.8%, P=.13). Patients in the
endovascular repair group had reduced median procedure time (2.9 vs 3.7 hours), blood
loss (200 vs 1000 mL), transfusion requirement (0 vs 1.0 units), duration of mechani-
cal ventilation (3.6 vs 5.0 hours), hospital stay (3 vs 7 days), and intensive care unit
stay (1 vs 4 days), but required substantial exposure to fluoroscopy and contrast. There
were no differences between the 2 groups in major morbidity, procedure failure, sec-
ondary therapeutic procedures, aneurysm-related hospitalizations, health-related qual-
ity of life, or erectile function.
Conclusions In this report of short-term outcomes after elective AAA repair,
perioperative mortality was low for both procedures and lower for endovascular than
open repair. The early advantage of endovascular repair was not offset by increased
morbidity or mortality in the first 2 years after repair. Longer-term outcome data are
needed to fully assess the relative merits of the 2 procedures.
Trial Registration clinicaltrials.gov Identifier: NCT00094575
JAMA. 2009;302(14):1535-1542 www.jama.com
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mum external diameter of at least 5.0
cm, (2) an associated iliac aneurysm
with a maximum diameter of at least 3.0
cm, or (3) a maximum diameter of at
least 4.5 cm plus either rapid enlarge-
ment (at least 0.7 cm in 6 months or
1.0 cm in 12 months) or saccular mor-
phology. To be randomized, a patient
had to have completed all preopera-
tive evaluation, be considered a candi-
date for both procedures by the par-
ticipating vascular surgeon, and meet
the manufacturer’s indications for the
endovascular system that would be used
if so assigned. Patients were excluded
if they had previous abdominal aortic
surgery, needed urgent repair, or were
unable or unwilling to give informed
consent or follow the protocol.
Procedures
Entry evaluation included demograph-
ics (race was recorded by study nurses
using predefined categories of white, not
of Hispanic origin; black, not of His-
panic origin; Hispanic; Asian/Oriental or
Pacific Islander; American Indian or Alas-
kan Native; or other); comorbidities;
medications; surgical risk using criteria
developed by the RAND Corporation
(eAppendix; available online at
http://www.jama.com)5; measurement of
height, weight, brachial, and ankle blood
pressure; measurement of serum creati-
nine; and various parameters from pre-
operative aortic imaging.
Patients provided informed consent
for preoperative evaluation and random-
ization. Randomization assigned equal
probability to open or endovascular re-
pair and was stratified by medical cen-
ter using a permuted block design. Al-
location was made by telephone to the
coordinating center after baseline infor-
mation was received and eligibility veri-
fied. Although patient assignment was of
necessity unblinded, outcome data by
treatment group were available during
enrollment only to the biostatistician and
data monitoring committee.
Open repair involves sutured anasto-
moses of an anatomically placed vascu-
lar graft through an abdominal or retro-
peritoneal incision and was performed as
usual at each participating medical cen-
ter. Endovascular repair involves the
transluminal introduction of an expand-
able graft system through the femoral or
iliac arteries into the aneurysmal region
of the aorta and iliac arteries to exclude
the aneurysm from arterial pressure. Only
endovascular systems approved by the
US Food and Drug Administration could
be used in the study. To permit subgroup
comparisons with randomized controls,
the endovascular system intended for a
particular patient if so assigned was re-
ported to the coordinating center before
randomization.
The protocol specified that repair
should occur within 6 weeks of random-
ization and a study-approved vascular
surgeon or interventional radiologist
should perform all aneurysm repairs. Cri-
teria for study approval were vascular
surgery fellowship, certification or
equivalent, or equivalent training for in-
terventional radiologists. Individuals per-
forming study endovascular proce-
dures were required to have completed
at least 12 procedures with adequate
supervision.
Follow-up visits were scheduled 1
month after aneurysm repair, 6 and 12
months after enrollment, and then yearly.
All follow-up visits after endovascular re-
pair included computed tomography and
plain radiography of the abdomen,
whereas after open repair, only com-
puted tomography at 1 year was speci-
fied, a difference intended to reflect usual
clinical practice. Patients were called
monthly during the first 14 months af-
ter repair and then annually midway be-
tween study visits to identify outcomes
and were asked to log all health care vis-
its. Additional follow-up information was
obtained by the coordinating center using
national data sets.
Outcome Measures
The primary outcome is long-term (5-9
years) all-cause mortality (October 15,
2002-October 15, 2011). Secondary
outcomes included (1) procedure fail-
ure, defined as failure to complete the
initial repair or any secondary thera-
Figure 1. Flow Diagram of Study Patients
444 Included in primary analysis 437 Included in primary analysis
444 Randomized to receive endovascular repair
427 Received endovascular repair as
randomized
2 Refused repair
12 Had open repair
7 After endovascular repair aborted
3 Due to patient request
1 Due to urgent symptoms
1 Was not a candidate for
endovascular repair
2 Died before repair
1 Had repair aborted and never
completed
9 Had endovascular repair >6 wk
after randomization
17 Did not receive endovascular repair
437 Randomized to receive open repair
416 Received open repair as randomized
21 Did not receive open repair
4 Refused repair
13 Had endovascular repair
3 After open repair aborted
4 Due to patient request
6 Due to medical problems
1 Died before repair
3 Had repair aborted and never
completed
15 Had open repair >6 wk after
randomization
429 Were enrolled for >1 y
350 Were enrolled for >2 y
31 Died
2 Lost to follow-up
421 Were enrolled for >1 y
348 Were enrolled for >2 y
43 Died
0 Lost to follow-up
881 Randomized
5161 Patients assessed for eligibility
4280 Excluded
834 Had AAA <5.0 cm
2702 Were not candidates for both procedures
and/or failed to complete evaluation
294 Were unlikely or unable to comply
450 Refused randomization
AAA indicates abdominal aortic aneurysm.
ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
1536 JAMA, October 14, 2009—Vol 302, No. 14 (Reprinted) ©2009 American Medical Association. All rights reserved.
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peutic procedures resulting directly or
indirectly from the initial procedure and
requiring a separate trip to the proce-
dure suite (each trip to the procedure
suite counted as 1 secondary proce-
dure, and these included any un-
planned surgical procedures within 30
days of the initial procedure and any ad-
ditional aorto-iliac procedures at any
time); (2) short-term major morbid-
ity, defined as myocardial infarction,
stroke, amputation, or renal failure re-
quiring dialysis within 1 year after the
initial repair; (3) days in hospital and
ICUs associated with the initial repair;
(4) other procedure-related morbidi-
ties, such as incisional hernia, or new
or worsened claudication; (5) health-
related quality of life; and (6) erectile
dysfunction. These secondary out-
comes pertain primarily to the short-
term perioperative period and are the
main focus of this report.
Outcomes were adjudicated by an
outcomes committee blinded (to the ex-
tent possible) to the randomized group.
Aneurysm-related mortality was not a
prespecified outcome because of the po-
tential for ascertainment bias4but is pre-
sented for comparison with other trials.
All deaths within 30 days after repair
or during the hospitalization for re-
pair were considered aneurysm-
related, as were all late deaths adjudi-
cated as resulting directly or indirectly
from the AAA or treatment of the AAA.
Health-related quality of life was as-
sessed by using 2 brief questionnaires,
the 36-item Short Form Health Survey
(SF-36) and EQ-5D (EuroQol, Rotter-
dam, the Netherlands), completed at
baseline and follow-up visits. The SF-36
evaluates 8 health dimensions that have
been aggregated into 2 summary mea-
sures, a mental component summary
and a physical component summary.6
We also computed the physical com-
ponent transformed with deaths in-
cluded.7The EQ-5D8consists of 5 ques-
tions used to generate an index score
with US population-based preference
weights, and a 20-cm visual analog
scale. Erectile function was assessed by
using the previously validated 5-item
International Index of Erectile Func-
Table 1. Patient Characteristics at the Time of Randomizationa
Characteristics
Endovascular Repair
(n = 444)
Open Repair
(n = 437)
Age, mean (SD), y 69.6 (7.8) 70.5 (7.8)
Male sex, No. (%) 441 (99.3) 435 (99.5)
White race, No. (%) 387 (87.2) 379 (86.7)
Weight, mean (SD), kg 89.9 (16.8) 89.7 (17.8)
BMI, mean (SD) 28.6 (5.2) 28.7 (5.6)
BMI ⱖ35, No. (%) 47 (10.6) 44 (10.1)
Smoking history, No. (%)
Ever 428 (96.4) 413 (94.5)
Current 170 (38.3) 193 (44.2)
Blood pressure, mean (SD), mm Hg
Systolic 133.5 (18.6) 133.0 (18.8)
Diastolic 75.8 (10.9) 74.3 (10.6)
Current history, No. (%)
Coronary artery disease 174 (39.2) 185 (42.3)
Myocardial infarction 105 (23.6) 110 (25.2)
Coronary revascularization 159 (35.8) 153 (35.0)
Cerebrovascular disease 67 (15.1) 70 (16.0)
Hypertension 347 (78.2) 330 (75.5)
Claudication 66 (14.9) 81 (18.5)
Cancer (other than skin) 83 (18.7) 70 (16.0)
Diabetes 100 (22.5) 100 (22.9)
Chronic obstructive pulmonary disease 126 (28.4) 133 (30.4)
Medications, No. (%)
-Blocker 282 (63.5) 282 (64.5)
Aspirinb244 (55.0) 277 (63.4)
ACE inhibitor 192 (43.2) 180 (41.2)
Anticoagulants 44 (9.9) 34 (7.8)
Ankle-brachial index on at least 1 side, No. (%)
ⱕ0.9 159 (35.8) 155 (35.5)
ⱕ0.4 48 (10.8) 45 (10.3)
Maximum activity level, No. (%)
Sedentary or mild 182 (41.0) 185 (42.4)
Moderate or vigorous 262 (59.0) 252 (57.6)
Serum creatinine, mean (SD), mg/dL 1.2 (0.5) 1.1 (0.4)
GFR ⬍60 mL/min per 1.73 m2, No. (%) 140 (31.5) 136 (31.1)
Surgical risk (RAND score), No. (%)
Low 240 (54.1) 227 (51.9)
Intermediate 169 (38.1) 176 (40.3)
High 31 (7.0) 29 (6.6)
Family history of AAA, No. (%) 70 (15.8) 51 (11.7)
AAA diameter, No. (%), cm
Mean (SD) 5.7 (0.8) 5.7 (1.0)
⬍5.0 23 (5.2) 18 (4.1)
⬍5.5 192 (43.2) 190 (43.5)
5.5-5.9 133 (30.0) 123 (28.1)
6.0-6.9 86 (19.4) 83 (19.0)
ⱖ7.0 33 (7.4) 41 (9.4)
Intended device, No. (%)
Cook Zenith 166 (37.4) 175 (40.0)
Gore Excluder 177 (39.6) 150 (34.3)
Medtronic AneuRx 88 (19.8) 98 (22.4)
Other 13 (2.9) 14 (3.2)
Abbreviations: AAA, abdominal aortic aneurysm; ACE, angiotensin-converting enzyme; BMI, body mass index (calcu-
lated as weight in kilograms divided by height in meters squared); GFR, glomerular filtration rate.
SI conversion factor: To convert serum creatinine to µmol/L, multiply by 88.4.
aEver smoking history is smoking more than 100 cigarettes over lifetime. The GFR was estimated using the 4-variable
Modification of Diet in Renal Disease Study equation.14 For surgical risk (RAND score), see online eAppendix at http:
//www.jama.com.5Intended device indicates if assigned to endovascular repair.
bP=.01.
ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, October 14, 2009—Vol 302, No. 14 1537
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tion.9Questionnaires were completed
by the patient and reviewed for com-
pleteness by study personnel.
Statistical Analysis
We originally assumed a mortality rate
of 5.6% per year following open repair10-12
and 5% loss to follow-up, and planned a
4.5-year enrollment period and a mini-
mum follow-up of 3.5 years. Three years
after enrollment began in October 2002,
the study was reconfigured by the inves-
tigators with the approval of the data and
safety monitoring board without knowl-
edge of results by randomized group to
reflect lower than planned enrollment
rate, higher mortality rate (6.6% per year),
and lower losses to follow-up (1%). By
increasing enrollment to 5 years and fol-
low-up to 4 years, 872 patients would
provide 80% power to detect a 25% rela-
tive reduction in mortality with 2-sided
␣= .05. To reach this number of patients,
enrollment was continued an addi-
tional 6 months at 3 centers.
The analysis was by intention-to-
treat. Estimates of cumulative event
rates were calculated by the Kaplan-
Meier method, and hazard ratios (HRs)
with confidence intervals (CIs) were es-
timated by Cox proportional hazards re-
gression models.13 The effect of treat-
ment in prespecified subgroups was
assessed by treatment-subgroup inter-
actions in the Cox proportional haz-
ards regression model. Variables were
compared by using 2and ttests. Pval-
ues were 2-sided and P⬍.05 was con-
sidered statistically significant. Statis-
tical analyses were performed by using
SAS version 9.1 (SAS Institute Inc, Cary,
North Carolina).
The protocol originally specified pub-
lication of 1-year results when avail-
able on all patients to ensure that short-
term postoperative outcomes would be
disseminated while still maximally rel-
evant. Because of the important changes
in the effect size for survival noted dur-
ing the second year of follow-up in pre-
viously published trials,2-4 this plan was
amended by the investigators with the
approval of the data and safety moni-
toring board without knowledge of the
results in February 2007 to include all
follow-up data to 2 years after random-
ization as of the same date of October
15, 2008.
RESULTS
We randomized 881 patients (aged ⱖ49
years) at 42 medical centers (FIGURE 1).
Table 2. Details of Aneurysm Repair by Randomly Assigned Groupa
Median (Interquartile Range)
Endovascular Repair
(n = 439)
Open Repair
(n = 429)
Patients with aorta as distal attachment site
(vs iliac/femoral), No. (%)
23 (5.2) 190 (44.3)
Time from randomization to repair, d 18.0 (10.0-28.0) 17.0 (9.0-26.0)
Duration of procedure, h 2.9 (2.3-3.7) 3.7 (2.9-4.7)
Duration of mechanical ventilation, h 3.6 (3.0-4.5) 5.0 (4.0-9.1)
Duration of fluoroscopy, min 23.0 (17.0-31.0) 0
Volume of contrast used, mL 132.5 (96.5-176.0) 0
Estimated blood loss, mL 200 (150-400) 1000 (650-2000)
Banked red cell transfusion within 24 h, unit 0 1.0 (0-3.0)
Duration of hospital stay for initial repair, d 3.0 (2.0-5.0) 7.0 (6.0-10.0)
Time in intensive care unit, d 1.0 (1.0-2.0) 4.0 (3.0-6.0)
aPatients who had no repair (refused, aborted and never completed, or died before repair as shown in Figure 1) are not
included.P⬍.001 for all comparisons of means, except time from randomization to repair (P=.36).
Table 3. All Outcome Measures
Outcomes
No. (%) of Patients
P
Value
Endovascular Repair
(n = 444)
Open Repair
(n = 437)
All-cause mortality 31 (7.0) 43 (9.8) .13
Before AAA repair 2 (0.5) 1 (0.2) ⬎.99
Within 30 d after repair 1 (0.2) 10 (2.3) .006
Within 30 d after repair or during hospitalization 2 (0.5) 13 (3.0) .004
AAA diameter ⬍5.5 cm 1 (0.5) 5 (2.6) .10
AAA diameter ⱖ5.5 cm 1 (0.4) 8 (3.2) .02
After 30 d or hospitalization 27 (6.1) 29 (6.6) .74
Cause of death (n = 31) (n = 43)
AAA-relateda6 (1.4) 13 (3.0) .10
Cardiovascular 9 (2.0) 4 (0.9) .26
Cancer 10 (2.3) 15 (3.4) ⬎.99
Otherb5 (1.1) 7 (1.6) .54
Unknown 1 (0.2) 4 (0.9) .21
Patients with procedure failure 58 (13.1) 51 (11.7) .53
Patients with no repair attempted 4 (0.9) 5 (1.1) .75
Patients with aborted initial procedure 8 (1.8) 6 (1.4) .61
Patients having secondary therapeutic
procedures
46 (10.4) 40 (9.2) .73
All secondary therapeutic procedures, No. of events 61 55
Patients with any 1-year major morbidity 18 (4.1) 20 (4.6) .70
Myocardial infarction 6 (1.4) 12 (2.7) .14
Stroke 7 (1.6) 4 (0.9) .38
Amputation 1 (0.2) 3 (0.7) .37
Renal failure requiring dialysis 5 (1.1) 3 (0.7) .73
Patients with new or worsened claudication 37 (8.3) 20 (4.6) .02
All postrepair aneurysm-related hospitalizations,
No. of events
108 86
Abbreviation: AAA, abdominal aortic aneurysm.
aIncludes all deaths within 30 days after repair or during hospitalization.
bIncludes cerebrovascular disease, injury, pneumonia, other infections, and unexplained sudden deaths not considered
AAA-related.
ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
1538 JAMA, October 14, 2009—Vol 302, No. 14 (Reprinted) ©2009 American Medical Association. All rights reserved.
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The 2 groups were similar at baseline
(TABLE 1), with no significant differ-
ences except for a greater proportion
using aspirin in the open repair group.
Of the 41 patients randomized with
AAA of less than 5.0 cm, reasons for eli-
gibility were iliac aneurysm in 34 pa-
tients, rapid enlargement in 4 pa-
tients, and saccular morphology in 3
patients. Fifteen patients (8 endovas-
cular repair and 7 open repair) had ab-
dominal or back pain noted before re-
pair, but no aneurysm ruptures were
identified at any time during the study
period. More than 95% of randomized
patients had the assigned repair
(n =843) and in another 2% (n =14), the
assigned repair was attempted but
aborted (Figure 1).
All 109 lead proceduralists for aneu-
rysm repair were vascular surgeons. An
endovascular system other than the one
prespecified as intended was used in 43
patients in the endovascular group. En-
dovascular repair resulted in signifi-
cantly reduced procedure time, dura-
tion of mechanical ventilation, hospital
and ICU stays, blood loss, and transfu-
sion requirement, but required substan-
tial exposure to fluoroscopy and con-
trast (TABLE 2).
Mean follow-up was 1.8 years, and
80% of patients (n=710) had either
completed 2 years of follow-up or died
before 2 years (follow-up was trun-
cated at 2 years for both study groups).
Perioperative mortality was signifi-
cantly higher for open repair at 30 days
(0.2% vs 2.3%; P=.006), and at 30 days
or during hospitalization (0.5% vs 3.0%;
P=.004) (TABLE 3), a difference that did
not appear to vary with AAA diameter
(Pfor interaction=.25). Vital status af-
ter 2 years or by October 15, 2008, was
confirmed for all but 2 patients, and na-
tional data sets contained no death re-
ports on these 2 patients. There was no
significant difference in all-cause mor-
tality at 2 years (7.0% vs 9.8%; HR, 0.7;
95% CI, 0.4-1.1; P=.13) (FIGURE 2).
Mortality after the perioperative pe-
riod was similar in the 2 groups (6.1%
vs 6.6%) (Table 3), but 4 of the late
deaths in the endovascular group were
aneurysm-related compared with none
in the open repair group. No signifi-
cant differences in mortality were ob-
served for any of the prespecified sub-
groups shown in FIGURE 3, including
patients with coronary artery disease
(P=.06). No significant interactions
were found between treatment effect
and any subgroup characteristic.
No differences were observed be-
tween the 2 groups in procedure fail-
ures, secondary therapeutic proce-
dures, aneurysm-related hospitalizations,
or 1-year major morbidity (Table 3). The
61 secondary therapeutic procedures in
the endovascular repair group included
42 endovascular procedures, 3 explan-
tations of the graft with conversion to
open repair, 9 other arterial procedures
with an open component, 5 groin wound
procedures, and 2 amputations (both legs
of 1 patient). The 55 secondary thera-
peutic procedures in the open-repair
group included 24 incisional hernia re-
pairs, 7 aortic graft procedures, 4 pro-
cedures for wound complications, 4 am-
putations (1 toe, 1 leg, and below and
above knee on same leg), 4 laparoto-
mies for bowel obstruction, 2 laparoto-
mies for hematoma, 2 procedures to re-
lieve claudication, and 8 miscellaneous
minor procedures.
Incisional hernia was reported in 30
patients who had open repair, result-
ing in secondary therapeutic proce-
dures in 21 patients (4.9%), all of whom
had undergone an anterior surgical ap-
proach in the original open repair. In
the endovascular repair group, there
were 134 endoleaks (blood flow be-
tween the graft and the aneurysm wall)
in 110 patients (25%), resulting in 21
secondary therapeutic procedures in 18
patients (4.1%).
Figure 2. Kaplan-Meier Curve of Cumulative
Probabilities of Death From Time of Randomization
0.12
0.09
0.06
0.03
0
No. at risk
Open repair
Endovascular
repair
6 1812
420 363396
433 371411
24
310
326444
437
Months
Cumulative
Mortality Proportion
Endovascular repair
Open repair
There was no significant difference in cumulative mor-
tality for open vs endovascular repair (hazard ratio,
0.7; 95% confidence interval, 0.4-1.1; log-rank P=.13).
Figure 3. Hazard Ratios for Death According to Baseline Characteristics
Favors
Endovascular
Repair
Favors
Open
Repair
5.0
1.00.2
Hazard Ratio (95% CI)
No.
Subgroup
Hazard Ratio
(95% CI)
Randomization period
Before April 15, 2005 0.6 (0.3-1.2)
After April 15, 2005 0.8 (0.4-1.6)
Surgical risk (RAND score)
Low 0.7 (0.3-1.4)
Intermediate or high 0.7 (0.4-1.3)
Coronary artery disease
No 0.9 (0.5-1.6)
Yes 0.5 (0.2-1.0)
Intended endovascular system
Cook Zenith 0.6 (0.3-1.4)
Gore Excluder 0.6 (0.3-1.2)
Medtronic AneuRx 1.7 (0.6-4.7)
Overall 0.7 (0.4-1.1)
Age, y
<70 0.6 (0.3-1.3)
≥70 0.8 (0.4-1.4)
AAA diameter, cm
<5.5 0.7 (0.3-1.5)
Deaths
40
34
29
42
43
31
26
28
15
74
26
48
27
47
Patients
413
468
467
405
522
359
341
327
186
881
406
475
382
499≥5.5 0.7 (0.4-1.2)
AAA indicates abdominal aortic aneurysm; CI, confidence interval. Size of the data markers is relative to the
number of deaths in that subgroup. All P⬎.10 for interaction with treatment effect. For surgical risk (RAND
score), see online eAppendix at http://www.jama.com.5
ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, October 14, 2009—Vol 302, No. 14 1539
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As shown in TABLE 4, there were no
significant differences between the 2
groups in health-related quality of life
or erectile function over the 2 years of
follow-up.
COMMENT
In this interim report of 2-year out-
comes after elective AAA repair, endo-
vascular repair resulted in lower
perioperative mortality than open re-
pair without evidence of excess late
mortality. Hospital and ICU stays were
shorter with endovascular repair and
need for transfusion was decreased. No
significant differences were observed in
major morbidities, secondary proce-
dures, or aneurysm-related hospital-
izations.
Two European trials, the United
Kingdom Endovascular Aneurysm Re-
pair Trial 1 (EVAR-1)15 and the Dutch
Randomized Endovascular Aneurysm
Management (DREAM) trial,16 previ-
ously reported lower operative mortal-
ity with endovascular vs open repairs.
Perioperative mortality in our study was
lower than in the European trials for
both treatments. Mortality within 30
days or during hospitalization for en-
dovascular repair was 2.1% in the
EVAR-1 trial, 1.2% in the DREAM trial,
and 0.5% in our study, and for open re-
pair, mortality was 6.2% in the EVAR-1
trial, 4.6% in the DREAM trial, and 3.0%
in our study.15,16 We did not observe the
increased mid-term mortality after en-
dovascular repair that resulted in the
loss of its early survival advantage in
those trials,2,3 but all 4 late aneurysm-
related deaths in our study occurred in
the endovascular group.
The lower perioperative mortality in
our study compared with the previous
trials could result from several pos-
sible factors. First, our procedures were
performed more recently, from 2002-
2007 compared with 1999-2003 in the
EVAR-1 and DREAM trials. Of the 15
deaths within 30 days after repair or
during hospitalization in our study, 10
occurred in the first 412 patients, en-
rolled before April 15, 2005, includ-
ing the 2 deaths in the endovascular
group.
Second, our results could have been
improved by enrollment of patients
with small AAA. Forty-three percent
of our patients (n=382) had aneu-
rysms smaller than 5.5 cm in diameter
and therefore would not have been eli-
gible for enrollment in the EVAR-1
trial. However, perioperative mortality
rates (Table 3) and treatment effects
(Figure 3) were similar between
patients with AAA of less than 5.5 cm
and those with larger AAA, suggesting
that AAA diameter was not an impor-
tant factor.
Third, there could be differences in
surgical technique and postoperative
care between our trial and the Euro-
pean trials. Procedures in our trial were
performed by experienced university-
affiliated vascular surgeons. Although
the participation of more than 100 sur-
geons in our trial supports generaliz-
ability within this group, and proce-
dures in the European trials were also
performed by experienced vascular sur-
geons, differences between trials in sur-
gical technique and postoperative care
cannot be completely excluded. Inpa-
tient mortality following nonruptured
open AAA repair in the United States
during our enrollment period was
4.5%,1roughly half that in the United
Kingdom during the EVAR-1 enroll-
ment period,17,18 a difference that re-
flects the differences in operative mor-
talities between trials. Furthermore,
previous studies have reported low
perioperative mortality for AAA re-
pair in the Veterans Affairs health sys-
tem compared with other US health care
organizations.19,20
Fourth, there were differences in the
endovascular systems used. The
EVAR-1 trial used the Medtronic Tal-
ent (which was not approved for use in
the United States until after our enroll-
ment ended) in a third of the patients
and used the Gore Excluder and
Medtronic AneuRx much less fre-
quently than in our study. We did not
find significant interactions between de-
vice selection and treatment effect in
our study, although there was a non-
significantly less favorable outcome af-
ter endovascular repair with AneuRx
compared with other endovascular sys-
tems (Figure 3), and the 2 periopera-
tive deaths and 2 of the 4 late
aneurysm-related deaths in our endo-
Table 4. Quality of Life and Erectile Dysfunctiona
Measures
Mean (SD)
Baseline 1 Year Minus Baseline 2 Years Minus Baseline
Endovascular Repair Open Repair Endovascular Repair Open Repair Endovascular Repair Open Repair
SF-36
MCS 50.6 (10.9) 51.7 (10.4) −0.77 (10.2) −0 (10.0) −0.01 (10.0) −0.93 (9.8)
PCS 40.5 (10.4) 40.1 (10.5) −1.2 (9.8) −1.2 (10.1) −2.2 (10.2) −2.0 (10.8)
PCTD 62.5 (22.8) 61.6 (22.8) −3.0 (22.0) −2.8 (22.3) −5.0 (23.3) −4.29 (23.4)
EQ-5D
Index score 0.79 (0.16) 0.79 (0.16) −0.02 (0.16) −0 (0.17) −0.01 (0.19) −0.02 (0.16)
Visual analog scale 71.5 (19.1) 70.3 (18.6) −1.3 (18.9) 0.88 (17.8) −2.2 (22.3) −1.4 (20.3)
IIEF-5 11.4 (8.7) 10.3 (8.8) −2.5 (8.3) −2.3 (7.8) −3.0 (8.5) −2.9 (8.5)
Abbreviations: EQ-5D, EuroQol; IIEF-5, 5-item International Index of Erectile Function; MCS, mental component summary; PCS, physical component summary; PCTD, physical com-
ponent transformed with deaths included; SF-36, 36-item Short Form Health Survey.
aFor endovascular vs open repair, all P⬎.05. The MCS, PCS, and PCTD scores are 0 to 100, with 100 representing better health. The EQ-5D (EuroQol, Rotterdam, the Netherlands)
index scores range from 0 (death) to 1.0 (perfect health) and visual analog scale scores from 0 (“worst imaginable health state”) to 100 (“best imaginable health state”). The IIEF-5 scores
range from 5 to 25, with 25 representing better function.
ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
1540 JAMA, October 14, 2009—Vol 302, No. 14 (Reprinted) ©2009 American Medical Association. All rights reserved.
Downloaded From: http://jama.jamanetwork.com/ on 02/25/2013
vascular group were in the AneuRx sub-
group, suggesting that greater use of this
device probably did not improve sur-
vival in our study relative to the Euro-
pean trials. In 2008, the US Food and
Drug Administration issued a public
health notification regarding higher
than expected late aneurysm–related
mortality with AneuRx.21 Longer fol-
low-up is needed to monitor perfor-
mance of the various graft systems.
Our findings of no difference in ma-
jor morbidities or secondary therapeu-
tic procedures contrast with the
EVAR-1 findings of highly significant
differences favoring open repair in com-
plications and reinterventions.2At least
some of these differences between the
2 trials may result from how the cat-
egories were defined. For example, the
EVAR-1 trial appears to have counted
as reinterventions only procedures di-
rectly related to graft placement,
whereas our study included any sec-
ondary therapeutic procedures result-
ing from the original procedure, such
as incisional hernia repairs. Incisional
hernia repairs were the most common
secondary therapeutic procedures in the
open-repair group in our study, occur-
ring in 4.9% of patients at 2 years. This
is comparable with the 5.8% rate re-
ported in a Medicare population within
4 years after open repair.22 A recent
meta-analysis found that open AAA re-
pair carries a 5-fold greater risk of in-
cisional hernia than does surgery for
aortoiliac occlusive disease, possibly re-
flecting an underlying collagen defect
in patients with AAA.23
Health-related quality of life de-
creased in the early postoperative pe-
riod in the European trials, particu-
larly following open repair, but these
changes resolved before 6 months.4In
the DREAM trial,24 quality of life at 6
months and 1 year was lower in the en-
dovascular group. Our study focused
on later postoperative quality of life and
found no differences between the 2
groups at 1 and 2 years.
Open AAA repair results in erectile
dysfunction in some patients, al-
though most of the dysfunction ob-
served after repair in 1 large trial was
not new.25 Erectile dysfunction has been
reported to be reduced after endovas-
cular repair compared with open re-
pair, but these data are from nonran-
domized retrospective surveys and are
subject to recall and response bias.26,27
Our finding of no difference between
open and endovascular repair in erec-
tile dysfunction at 1 and 2 years is in
agreement with randomized prospec-
tive data from the DREAM trial, which
reported no difference between open
and endovascular repair in erectile dys-
function at 3, 6, and 12 months.28
CONCLUSION
In this randomized trial, endovascular
repair resulted in fewer perioperative
deaths than open repair, even though
open repair was performed with low
mortality. This early advantage was not
offset by increased morbidity or mor-
tality in the endovascular group in the
first 2 years after repair. Longer-term
data are needed to fully assess the rela-
tive merits of the 2 procedures.
Author Affiliations: Medicine Service, Veterans Af-
fairs Medical Center, Minneapolis, Minnesota (Dr Led-
erle); Surgery Service, Veterans Affairs Medical Cen-
ter, Baltimore, Maryland (Dr Freischlag); Cooperative
Studies Program Coordinating Center, Veterans Af-
fairs Medical Center, West Haven, Connecticut (Drs
Kyriakides and Peduzzi); Surgery Service, Veterans Af-
fairs Medical Center, East Orange, New Jersey (Dr Pad-
berg); Surgery Service, Veterans Affairs Medical Cen-
ter, Madison, Wisconsin (Dr Matsumura); Surgery
Service, Veterans Affairs Medical Center, Seattle, Wash-
ington (Dr Kohler); Surgery Service, Veterans Affairs
Medical Center, Houston, Texas (Dr Lin); Surgery Ser-
vice, Veterans Affairs Medical Center, Cleveland, Ohio
(Dr Jean-Claude); Surgery Service, Veterans Affairs
Medical Center, Indianapolis, Indiana (Dr Cikrit); and
Cooperative Studies Program Clinical Research Phar-
macy Coordinating Center, Albuquerque, New Mexico
(Ms Swanson).
Author Contributions: Drs Lederle and Kyriakides had
full access to all of the data in the study and take re-
sponsibility for the integrity of the data and the ac-
curacy of the data analysis.
Study concept and design: Lederle, Freischlag,
Kyriakides, Padberg, Kohler, Lin, Peduzzi.
Acquisition of data: Freischlag, Kyriakides, Padberg,
Matsumura, Kohler, Lin, Jean-Claude, Cikrit,
Swanson.
Analysis and interpretation of data: Lederle, Freischlag,
Kyriakides, Padberg, Matsumura, Kohler, Jean-Claude,
Swanson.
Drafting of the manuscript: Lederle, Kyriakides,
Padberg, Matsumura, Kohler, Jean-Claude, Swanson,
Peduzzi.
Critical revision of the manuscript for important in-
tellectual content: Lederle, Freischlag, Kyriakides,
Padberg, Matsumura, Kohler, Lin, Jean-Claude, Cikrit,
Peduzzi.
Statistical analysis: Kyriakides.
Obtained funding: Lederle, Freischlag, Peduzzi.
Administrative, technical, or material support: Lederle,
Freischlag, Padberg, Matsumura, Kohler, Lin, Swanson,
Peduzzi.
Study supervision: Lederle, Freischlag, Padberg, Lin,
Cikrit.
Financial Disclosures: Dr Matsumura reported receiv-
ing research support, consultant fees, or training direc-
tor fees from Abbott/Guidant, Abraxis, Bard, Cook,
Cordis, ev3, Lumen, Medtronic, Sanofi, and WL Gore.
Dr Kohler reported receiving research support as an in-
vestigator for the Medtronic AneuRx Phase III clinical
trial. All other authors reported no financial disclosures.
Investigators and Site Coordinators of the Open Ver-
sus Endovascular Repair (OVER) Veterans Affairs Co-
operative Study Group: Participating Veterans Af-
fairs Medical Centers: Albuquerque, New Mexico: E.
R. Ketteler, MD, D. D. Kingsley, MD, J. M. Marek, MD,
R. J. Massen, MD, B. D. Matteson, MD, J. D. Pitcher,
MD, M. Langsfeld, MD, J. D. Corson, MD, J. M. Goff
Jr, MD, K. Kasirajan, MD, C. Paap, RN, D. C. Robert-
son, RN; Atlanta, Georgia: R. Veeraswamy, MD, R.
Milner, MD, A. Salam, MD, K. Kasirajan, MD, J. Guidot,
RN; Baltimore, Maryland: S. Busuttil, MD, M. P. Lilly,
MD, M. Braganza, K. Ellis, RN; Birmingham, Ala-
bama: M. A. Patterson, MD, W. D. Jordon, MD, D.
Whitley, MD, S. Taylor, MD, M. Passman, MD, D.
Kerns, RN, C. Inman, RN, J. Poirier, RN; Boston, Mas-
sachusetts: J. Ebaugh, MD, J. Raffetto, MD, D. Chew,
MD, S. Lathi, MD, C. Owens, MD, K. Hickson, RN;
Buffalo, New York: H. H. Dosluoglu, MD, K. Esch-
berger, RN; Chicago, Illinois: M. R. Kibbe, MD, H. M.
Baraniewski, MD, J. Matsumura, MD, A. Busman, RN,
W. Meadows, RN, M. Evans, RN; Cincinnati, Ohio:
H. El Sayed, MD, A. B. Reed, MD, J. S. Giglia, MD, S.
Ross, RN, M. Ruf, RN; Cleveland, Ohio: J. M. Jean-
Claude, MD, G. Pinault, MD, P. Kang, MD, N. White,
RN, M. Eiseman, RN, R. Jones, RN†; Dallas, Texas: J.
G. Modrall, MD, C. H. Timaran, MD, M. B. Welborn
III, MD, J. Lopez, MD, T. Nguyen; Detroit, Michigan:
J. K.Y. Chacko, MD, K. Granke, MD, A. G. Vouy-
ouka, MD, E. Olgren, P. Chand, MD, B. Allende; M.
Ranella, C. Yales, RN; Denver, Colorado: T. A. White-
hill, MD, W. C. Krupski, MD†, M. R. Nehler, MD, S.
P. Johnson, MD, D. N. Jones, PhD, P. Strecker, RN,
M. A. Bhola, RN; Durham, North Carolina: C. K. Short-
ell, MD, J. L. Gray, MD, J. H. Lawson, MD, M. W. Se-
bastian, MD, J. Kistler Tetterton, NP, C. Blackwell, RN,
P. A. Prinzo, BS, N. Lee, RN; East Orange, New Jer-
sey: F. T. Padberg Jr, MD, J. J. Cerveira, MD, B. K. Lal,
MD, R. W. Zickler, MD, K. A. Hauck, RN; Gaines-
ville, Florida: S. A. Berceli, MD, W. A. Lee, MD, C. K.
Ozaki, MD, P. R. Nelson, MD, A. S. Irwin, RN, R. Baum,
RN; Hines, Illinois: B. Aulivola, MD, H. Rodriguez, MD,
F. N. Littooy, MD, H. Greislev, MD, M. T. O’Sullivan,
RN; Houston, Texas: P. H. Lin, MD, R. L. Bush, MD,
P. Kougias, MD, G. Guinn, MD, C. Cagiannos, MD,
S. Pillack, RN, B. Guillory, RN; Indianapolis, Indiana:
D. Cikrit, MD, S. G. Lalka, MD, R. Nachreiner, MD,
M. Rusomaroff, RN, E. O’Brien, RN; Iowa City, Iowa:
J. Hoballah, MD, W. J. Sharp, MD, J. L. McCandless,
RN, V. Beach; Lexington, Kentucky: D. Minion, MD,
T. H. Schwarcz, MD, J. Kimbrough, RN, L. Ashe, A.
Rockich, MS, J. Warner-Carpenter, RN; Little Rock,
Arkansas: M. Moursi, MD, J. F. Eidt, MD, S. Brock RN;
Loma Linda, California: C. Bianchi, MD, V. Bishop,
RN; Long Beach, California: I. L. Gordon, MD, R.
Fujitani, MD, S. M. Kubaska III, MD, R. Azadegan, C.
Ma Agas, MPH, K. Zalecki; Madison, Wisconsin: J. R.
Hoch, MD, S. C. Carr, MD, C. Acher, MD, M.
Schwarze, MD, G. Tefera, MD, M. Mell, MD, J. Rieder,
RN; Memphis, Tennessee: J. M. Stuart, MD, D. S.
Weiman, MD, O. Abul-Khoudoud, MD, H. E. Gar-
rett, MD, S. M. Walsh, MA, K. L. Wilson, RN; Mil-
waukee, Wisconsin: G. R. Seabrook, MD, R. A. Cam-
bria, MD, K. R. Brown, MD, B. Lewis, MD, S. Framberg,
RN, C. Kallio, RN; Minneapolis, Minnesota: R. A. Barke,
MD, S. M. Santilli, MD, A. C. d’Audiffret, MD, N.
Oberle, RN, C. Proebstle, NP, L. L. Johnson, RN; New
York, New York: G. R. Jacobowitz, MD, N. Cayne, MD,
ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
©2009 American Medical Association. All rights reserved. (Reprinted) JAMA, October 14, 2009—Vol 302, No. 14 1541
Downloaded From: http://jama.jamanetwork.com/ on 02/25/2013
C. Rockman, MD, M. Adelman, MD, P. Gagne, MD,
M. Nalbandian, MD, L. J. Caropolo, BS; Omaha, Ne-
braska: I. I. Pipinos, MD, J. Johanning, MD, T. Lynch,
MD, H. DeSpiegelaere, RN, G. Purviance, RN; Palo
Alto, California: W. Zhou, MD, R. Dalman, MD, J. T.
Lee, MD, B. Safadi, MD, S. M. Coogan, MD, S. M.
Wren, MD, D. Bahmani, D. Maples, NP, S. Thunen,
RN; Philadelphia, Pennsylvania: M. A. Golden, MD,
M. E. Mitchell, MD, R. Fairman, MD, S. Reinhardt, RN;
Pittsburgh, Pennsylvania: M. A. Wilson, MD, E. Tz-
eng, MD, S. Muluk, MD, N. M. Peterson, RN, M. Fos-
ter, RN; Portland, Oregon: J. Edwards, MD, G. L. Mo-
neta, MD, G. Landry, MD, L. Taylor, MD, R. Yeager,
MD, E. Cannady, RN; Salt Lake City, Idaho: G. Treiman,
MD, S. Hatton-Ward, RN, B. Salabsky, RN†; San Fran-
cisco, California: J. H. Rapp, MD, L. M. Reilly, MD,
R. Sarkar, MD, S. S. Dwyer, RN; Seattle, Washing-
ton: T. R. Kohler, MD, T. S. Hatsukami, MD, D. G.
Glickerman, MD, M. Sobel, MD, T. S. Burdick, MD,
K. Pedersen, RN, P. Cleary, NP; San Diego, Califor-
nia: N. Kansal, MD, N. H. Kumins, MD, M. Estes, RN,
B. A. Forbes, RN, C. Sobotta, RN; Tampa, Florida: M.
Back, MD, D. Bandyk, MD, B. Johnson, MD, M.
Shames, MD, R. L. Reinhard, RN, S. C. Thomas, RN;
Tucson, Arizona: L. R. Leon Jr, MD, A. Westerband,
MD, R. J. Guerra, MD, M. Riveros, MD, J. L. Mills,
SR, MD, J. D. Hughes, MD, S. .B. Psalms, N. N. Day,
RN; Washington, DC: A. Sidawy, MD, J. M. Weis-
wasser, MD, S. Arora, MD, B. J. Jasper, M Ed; West
Haven, Connecticut: A. Dardik, MD, V. Gahtan, MD,
B. E. Muhs, MD, B. E. Sumpio, MD, R. J. Gusberg, MD,
M. Spector, MD, J. Pollak, MD, J. Aruny, MD, E. L.
Kelly, MD, J. Wong, MD, P. Vasilas, RN, C. Joncas,
RN; West Los Angeles, California: H. A. Gelabert, MD,
C. DeVirgillio, MD, D. A. Rigberg, MD, L. Cole, RN.
Executive Committee: Frank A. Lederle, MD, and Ju-
lie A. Freischlag, MD (co-chairpersons), Ted R. Kohler,
MD, Jon Matsumura, MD, Frank T. Padberg Jr, MD,
Tassos C. Kyriakides, PhD, Kathleen M. Swanson, MS,
RPh, Julie Thornton, Yvonne Jonk, PhD, Kevin T.
Stroupe, PhD.
Coordinating Centers and Committees: Coopera-
tive Studies Program Coordinating Center (CSPCC)
VA CT Healthcare System, West Haven, Connecti-
cut: Peter Peduzzi, PhD (director), Margaret
Antonelli (assistant director, operations), Cindy
Cushing (programmer), Lynn Durant (quality assur-
ance officer), Shirley Joyner, MHA (research coordi-
nator), Tassos C. Kyriakides, PhD (biostatistician),
Mary LeGwin (project manager), Terry O’Connor,
PhD (biostatistician), Scott Zellner, PhD (research
coordinator), Vanessa McBride (research coordina-
tor), Susan Stratton† (project manager), Elizabeth
Davis, RN, Alice Kossack, June Poulton, RN (re-
search associate); Regulatory Affairs and Clinical
Compliance Section, Cooperative Studies Program
Clinical Research Pharmacy Coordinating Center,
Albuquerque, New Mexico: Kathleen M. Swanson,
MS, RPH, Julie Thornton, BS; VA Research Site
Management and Review Team (SMART)VA Coop-
erative Studies Program, Albuquerque, New
Mexico: Clair M. Haakenson, RPH, MS; Health
Economists: Kevin T. Stroupe, PhD (Center for
Management of Complex Chronic Care, CSPCC,
Veterans Affairs Medical Center, Hines, Illinois),
Yvonne Jonk, PhD (Center for Chronic Disease
Outcomes Research, Veterans Affairs Medical Cen-
ter, Minneapolis, Minnesota); Human Rights Com-
mittee, West Haven, Connecticut: Richard Marot-
toli, MD, Stanislav Kasl, PhD, Rajni Mehta, MPH,
Richard Feldman, William Farrell, Heather Allore,
PhD, Edward Perry, MD, James Niederman, MD,
Sister Frances Randall, Reverend Michael Zeman,
Donald Beckwith; National Project Coordinators,
Minneapolis VAMC: Elizabeth Latts, MSW, Marilyn
Bader; Central Administration, Cooperative Studies
Program (VA Central Office): Timothy J. O’Leary,
MD, PhD, director, Clinical Science R&D Service,
Grant D. Huang, PhD, deputy director, CSP.
†Deceased.
Data and Safety Monitoring Board: John ( Jeb) W. Hal-
lett, MD (Roper-St. Francis Heart and Vascular Cen-
ter, Charleston, South Carolina), Norman Hertzer, MD
(The Cleveland Clinic, Cleveland, Ohio), Jonathan
Towne, MD (Medical College of Wisconsin, Milwau-
kee), David A. Katz, MD, MSc (Center for Research
in the Implementation of Innovative Strategies in Prac-
tice, US Department of Veterans Affairs, Iowa City
Health Care System, Iowa City, Iowa), Theodore Karri-
son, PhD (biostatistician) (Department of Health Stud-
ies, University of Chicago, Chicago, Illinois), John P.
Matts, PhD (biostatistician) (Coordinating Centers for
Biometric Research, University of Minnesota, Minne-
apolis).
Funding/Support: This work was supported by the Co-
operative Studies Program of the Department of Vet-
erans Affairs (VA) Office of Research and Develop-
ment, Washington, DC. Study nurses were
compensated directly by the VA study grant. Physi-
cian time was donated by the respective VA Medical
Centers. Statistical and other central VA personnel were
employed by the VA to work on various studies, in-
cluding this trial.
Role of the Sponsor: The sponsor had no role in the
design and conduct of the study; in the collection,
analysis, and interpretation of the data; or in the prepa-
ration, review, or approval of the manuscript.
Additional Information: Online eAppendix is avail-
able at http://www.jama.com.
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ENDOVASCULAR AND OPEN REPAIR OF ABDOMINAL AORTIC ANEURYSM
1542 JAMA, October 14, 2009—Vol 302, No. 14 (Reprinted) ©2009 American Medical Association. All rights reserved.
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