11
Adverse Event/Complication
In-Hospital
Cumulative thru
9 Months
Iliofemoral Bypass Graft Surgery
0.0% (0/151)
1.3% (2/151)
Infection/Abscess Formation
0.0% (0/151)
3.3% (5/151)
Pseudoaneurysm or AV Fistula at the Access Site
2.0% (3/151)
3.3% (5/151)
Thrombosis of Culprit Lesion
0.0% (0/151)
0.7% (1/151)
Tissue Necrosis Requiring Debridement
0.7% (1/151)
4.0% (6/151)
Worsened Claudication/Rest Pain
0.7% (1/151)
7.3% (11/151)
1
Two patients experienced multiple major adverse events. One patient had a non-Q-wave MI on day 87 followed by
a limb loss on day 119; and another had an MI on day 3 followed by death on day 8.
Rates for CEC-adjudicated related events, as well as total events, are shown in Table 5. Of
primary interest is the MAE rate at 9 months post-procedure for events adjudicated by the
Clinical Events Committee as related to the device or the procedure. This rate is 2.7% (4/146).
For related and non-related events combined, the total MAE rate is 7.5% (11/146). These study
results demonstrate that the MAE rate of the Zilver Vascular Stent is not greater than the
target value of 16%.
Table 5: Summary of Protocol-Defined Major Adverse Events Observed in 146 Patients
Implanted with the Zilver Vascular Stent
Major Adverse Event
Related Events
(CEC-Adjudicated)
All Events
N
%
N
%
Death
1
3
2.0
8
5.5
MI (Non-Q-Wave and Q-Wave)
0
0.0
1
0.7
TLR
1
0.7
1
0.7
Limb Loss
2
0
0.0
1
0.7
Total
4
2.7
11
7.5
1
One patient experienced a MI 5 days prior to the death.
2
One patient experienced a non-Q-wave MI 32 days prior to the limb loss.
Table 6 focuses on all (related and non-related) observed major adverse events and
demonstrates that for evaluable patients (n=146), the MAE rate is 7.5% (11 of 146). A more
conservative analysis of all evaluable patients counts all patients who withdrew from the
study and all who were lost to follow-up as Major Adverse Events. In this conservative
approach, the MAE rate becomes 10.6% (16 of 151). By both methods of analysis, the MAE
point estimate rate is below the OPC target value of 16%. This indicates that the primary study
endpoint was met.
Содержание Zilver
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