26
6.3 Patient Demographics
Tables 6.3.1 and 6.3.2 compare the subject characteristics and initial aneurysm diameter of the Zenith AAA Endovascular Graft and open surgical population,
respectively.
Table 6.3.1 Comparison of Subject Characteristics
Item
Zenith Standard Risk
Surgical Standard Risk
P
value
Zenith
High Risk
Zenith
Roll-in
Age (years)
71 ± 7
69 ± 7
.03
77 ± 7
74 ± 8
Gender male
94%
(187/200)
89%
(71/80)
.22
92%
(92/100)
90%
(47/52)
Current medical conditions
Peripheral vascular disease
16%
(31/195)
25%
(19/76)
.12
24%
(23/96)
9.6%
(5/52)
Hypertension
64%
(127/200)
83%
(65/78)
.001
68%
(67/99)
67%
(35/52)
Renal failure
0.0%
(0/197)
0.0%
(0/79)
>.99
5.2%
(5/97)
1.9%
(1/52)
COPD
20%
(39/199)
18%
(14/78)
.87
34%
(33/98)
22%
(11/51)
Thromboembolic event
4.5%
(9/199)
7.7%
(6/78)
.38
7.1%
(7/99)
1.9%
(1/52)
Liver disease
2.1%
(4/192)
5.1%
(4/79)
.24
1.0%
(1/99)
1.9%
(1/52)
Diabetes mellitus
12%
(24/199)
15%
(12/79)
.55
17%
(17/99)
14%
(7/51)
Insulin-dependent
17%
(4/24)
8.3%
(1/12)
.65
24%
(4/17)
43%
(3/7)
Previous medical conditions
MI
39%
(74/192)
29%
(23/80)
.13
35%
(34/98)
35%
(18/52)
Congestive heart failure
5.0%
(10/199)
12%
(9/78)
.07
16%
(16/100)
10%
(5/50)
Angina
49%
(98/198)
39%
(31/79)
.14
45%
(44/98)
44%
(23/52)
Arrhythmia
20%
(40/197)
22%
(17/78)
.87
28%
(27/98)
24%
(12/51)
Cerebrovascular disease
9.5%
(19/199)
16%
(13/79)
.14
20%
(20/99)
9.8%
(5/51)
Systemic infection
1.0%
(2/196)
0.0%
(0/78)
>.99
3.1%
(3/97)
0.0%
(0/49)
Cancer
22%
(43/200)
19%
(15/80)
.74
31%
(31/99)
29%
(15/51)
Family history of aneurysmal disease
16%
(24/150)
27%
(17/63)
.09
14%
(11/77)
26%
(10/38)
Previous surgery at site
10%
(20/200)
15%
(12/79)
.22
10%
(10/99)
14%
(7/51)
Previous radiation at site
0.5%
(1/197)
0.0%
(0/79)
>.99
2.0%
(2/100)
2.0%
(1/51)
Excessive alcohol use
3.6%
(7/193)
10%
(8/77)
.04
3.1%
(3/96)
4.0%
(2/50)
Tobacco use
Never smoked
10%
(20/193)
5.0%
(4/80)
14%
(13/96)
24%
(12/49)
Past smoker
69%
(133/193)
60%
(48/80)
.03
69%
(66/96)
57%
(28/49)
Still smokes
21%
(40/193)
35%
(28/80)
18%
(17/96)
18%
(9/49)
Due to inclusion criteria, high risk patients were older (
P
<.001), had more renal failure (
P
=.004), COPD (
P
=.01), congestive heart failure (
P
=.004) and cerebrovascular disease (
P
=.02) than
standard risk patients.
Table 6.3.2 Aneurysm Diameter Distribution
Diameter Range
Zenith Standard Risk
Surgical Standard Risk
Zenith High Risk
Zenith Roll-in
<30 mm
0.0%
(0/199)
0.0%
(0/78)
0.0%
(0/100)
0.0%
(0/52)
30-39 mm
0.5%
(1/199)
0.0%
(0/78)
1.0%
(1/100)
0.0%
(0/52)
40-49 mm
23%
(45/199)
7.7%
(6/78)
15%
(15/100)
13%
(7/52)
50-59 mm
48%
(95/199)
33%
(26/78)
47%
(47/100)
40%
(21/52)
60-69 mm
24%
(47/199)
29%
(23/78)
27%
(27/100)
42%
(22/52)
70-79 mm
3.0%
(6/199)
21%
(16/78)
5.0%
(5/100)
1.9%
(1/52)
80-89 mm
2.5%
(5/199)
6.4%
(5/78)
1.0%
(1/100)
0.0%
(0/52)
≥90 mm
0.0%
(0/199)
2.6%
(2/78)
1.0%
(1/100)
0.0%
(0/52)
Aneurysm diameter distribution was not assessed in three high-risk and one roll-in patient.
6.4 Results
Data gathered in Tables 6.4.1 through 6.4.3 were collected by the clinical study sites and Core Lab. Where available, 24-month data are provided. Control
patients were not followed beyond 12 months and some data have not yet been adjudicated beyond 12 months. Therefore, some results are presented to
12 months while other results are presented to 24 months in this section. Table 6.4.1 describes the devices implanted in clinical study patients. Table 6.4.2
describes the primary results from the clinical study. Figures 6.4.1 and 6.4.2 are the Kaplan-Meier plots of all-cause and AAA-related survival to 24 months,
respectively. An independent clinical events committee adjudicated all deaths for possible relationship to aneurysm repair. All early deaths (0-30 days) were
considered AAA-related. Deaths after 30 days were considered AAA-related if AAA disease or device involvement was confirmed. Table 6.4.3 presents Success
Measures and Figure 6.4.3 is the Kaplan-Meier plot of Freedom from Morbidity.
Table 6.4.1 Devices Implanted
Item
Zenith Standard Risk
Zenith High Risk
Zenith Roll-in
Main body and legs
99.5%
(199/200)*
100%
(100/100)
1
100%
(52/52)
Main body extension
2
1.5%
(3/199)
1.0%
(1/100)
5.8%
(3/52)
Ipsilateral iliac leg extension
3,5
9.5%
(19/199)
11%
(11/100)
0.0%
(0/52)
Contralateral iliac leg extension
4,5
11%
(21/199)
11%
(11/100)
13.5%
(7/52)
Converter
0.5%
(1/199)**
0.0%
(0/100)
0.0%
(0/52)
Occluder
0.0%
(0/199)
0.0%
(0/100)
0.0%
(0/52)
*One standard risk patient did not receive a device due to tortuosity and calcification of the access vessel.
**Converter was used without occluder.
1
One device was custom.
2
Two standard risk and one high risk patient received main body extensions postprocedure; one standard risk patient received two main body extensions.
3
Two standard risk and one high risk patient received ipsilateral leg extensions postprocedure.
4
Four standard risk, two high risk and one roll-in patient received contralateral leg extensions postprocedure.
5
Three standard risk and three high risk patients received both ipsilateral and contralateral extensions during the procedure; one standard risk received both ipsilateral and
contralateral extensions postprocedure.
Table 6.2.1 Patient Follow-Up and Accountability
1
Treatment
Zenith Standard Risk
Surgical Standard Risk
Interval
1 mo.
12 mo.
24 mo.
1 mo.
12 mo.
24 mo.
No device
1
1
2
1
2
0
0
n/a
Conversion to open repair
0
2
2
2
2
n/a
n/a
n/a
Expired
1
7
17
2
3
n/a
Withdrawn/lost to follow-up
0
0
2
0
4
n/a
Available
198
190
178
78
73
n/a
Site CT imaging
191
168
110
69
58
n/a
Core lab CT imaging
190
165
99
69
59
n/a
Site KUB imaging
179
153
108
n/a
n/a
n/a
Core lab KUB imaging
178
149
93
n/a
n/a
n/a
Site evaluated for endoleak
187
163
107
n/a
n/a
n/a
Core lab evaluated for endoleak
161
148
92
n/a
n/a
n/a
Site evaluated for aneurysm enlargement
n/a
149
104
n/a
n/a
n/a
Core lab evaluated for aneurysm enlargement
n/a
151
94
n/a
n/a
n/a
1
Data analysis sample size varies for each of the time points above and in the following tables. This variability is due to patient availability for follow-up, as well as quantity and quality
of images available from specific time points for evaluation. For example, the number and quality of images available for evaluation of endoleak at 12 months is different than the
number and quality of images available at 24 months due to variation in the number of image exams performed, the number of images provided from the clinical site to the Core Lab
and/or the number of images with acceptable evaluation quality. Totals at time points are not cumulative, unless otherwise noted.
2
Totals at time points are cumulative.
