Edwards SAPIEN 3

15
Table 7:
Primary Endpoint Analysis –
Non-Inferiority Test SAPIEN 3 Valve (PIIS3HR VI Population) vs. SAPIEN Valve
Event at 30 days
SAPIEN 3
Valve
(N = 583)
SAPIEN
Valve
(N = 326)
Weighted Proportion
Difference in Average
Treatment Effect
on the Treated (ATT)
Composite of Death, Stroke
and AI ≥ Moderate)
6.7%
[5.1%, 8.6%]
1
15.6%
[12.6%, 19.5%]
1
-6.9%
[-13.3%, -0.5%]
2
1
For each individual study, the two-sided 90% stratified Wilson confidence interval was provided.
2
The Wald-type two-sided 90% confidence interval using weighted mean and SD is provided
The Kaplan-Meier (K-M) estimates for all-cause mortality, cardiac mortality, and all stroke at 30 days for
the SAPIEN 3 cohort and the SAPIEN cohort are provided in Table 8.
Table 8:
Death and Stroke at 30 Days –
SAPIEN 3 Valve vs. SAPIEN Valve (VI Population)
SAPIEN 3 Valve
(N = 583)
SAPIEN Valve
(N = 326)
Event at 30
Days
No.
Events
No. Pts with
Events
K-M Estimated
Event Rate
1
(95% CI)
No.
Events
No. Pts with
Events
K-
M Estimated Event
Rate (95% CI)
Death 13 13
2.2%
([1.3%, 3.8%])
15 15
4.6%
([2.8%, 7.5%])
Cardiac
Death
8 8
1.4%
([0.7%, 2.7%])
10 10
3.1%
([1.7%, 5.7%])
All Stroke 9 9
1.6%
([0.8%, 3.0%])
14 14
4.3%
([2.6%, 7.2%])
1
Kaplan-Meier (K-M) estimates at 30 days used time to first event for each patient. Events occurring after 30 days
were not included in this analysis.
Secondary Endpoints
Aortic insufficiency by visit is provided in Figure 3.