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Study Design: In a prospective, randomized controlled study, a total of 142 patients
(Vectra-70, ePTFE-72) were enrolled at five institutions in the US. Patient characteris-
tics between the two groups were matched with respect to risk factors and demo-
graphics. All grafts implanted in this study were 6mm in diameter.
Primary endpoints included primary patency and functional patencies (secondary
patency), time to first thrombosis, and adverse events. In addition, the study also doc-
umented the time to first dialysis access and time to hemostasis after cannulation.
Time to first thrombosis, and primary and secondary patencies were determined from
the date of implant as well as the date of first dialysis access, because a significant
number of Vectra grafts were cannulated earlier than the control group.
Table 1. Primary & Secondary Patencies of Vectra and ePTFE grafts
Characteristic
Survival to first thrombosis
- from implant date
- from first dialysis date
Primary patency
- from implant date
- from first dialysis date
Functional patency
- from implant date
- from first dialysis date
As shown in Table 1, the primary and functional patencies for Vectra grafts are sub-
stantially equivalent to those for ePTFE grafts for both implant date and first dialysis
date outcomes. Major complications for both Vectra and ePTFE grafts are presented
in Table 2.
Table 2. Rate of Major Complications During the Study
Complication
General Events
Anastomotic Obstruction
Aneurysm
Infection, Surgical
Intragraft Obstruction
Kinking
Pseudoaneurysm
Wound Healing/Skin Erosion
Sub Total Complications
Native Vessel Disease
Arterial Disease
Central and Distal Vein Disease
Non-virginal arm related
Virginal arm incidents
Pre-existing Conditions
No Reported Conditions
Sub Total Complications
5
Patient Events
Deaths
6
Technical events
1. Patient within category may have had more than one complication.
2. Non-virginal arm is defined as prior implantation of a PTFE graft or the multiple place-
ments of fistulas (indicating multiple failed fistulas) in the same arm as the study graft.
3. Stenotic disease indicated by prior history or diagnostic procedures, temporary venous
catheter placement in the same side as study graft or history of multiple TVC placements,
and history of multiple prior shunt failures.
Vectra
(365 days)
42%
43%
36%
39%
75%
83%
Vectra
# events
51
0
5
13
7
0
2
1
78
6
2
10
3
4
28
10
54
7
11
18
3
®
Vectra
Vascular Access Graft
ePTFE
(365 days)
50%
47%
36%
30%
80%
82%
ePTFE
(#Pts)
# events
(#Pts)
(27)
35
(0)
0
(4)
6
(11)
17
(7)
0
(0)
3
(2)
0
(37)
61
(6)
2
(8)
3
(13)
12
(7)
13
(34)
30
(6)
2
(11)
10
(15)
8
p-value
0.14
0.46
0.33
0.77
0.55
0.75
(23)
(0)
(6)
(15)
(0)
(3)
(0)
(35)
(2)
(2)
(8)
(10)
(22)
(2)
(10)
(7)
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