44
Figure 27:
Disabling (Major) Stroke through 2 Years
(ITT Population)
Note
: The confidence intervals were calculated without multiplicity adjustment. The adjusted
confidence intervals could be wider than presented here. As such, confidence intervals are
provided to illustrate the variability only and should not be used to draw any statistical conclusion.
The results for the primary endpoint and its components for the SAPIEN XT ITT population by access
approach are presented in Table 26. The TF access had clinically lower all-cause death and disabling
(major) stroke rates than did the non-TF access.
Table 26:
All-Cause Death or Disabling (Major) Stroke to 2 Years by Access Approach
(SAPIEN XT ITT Population)
TF
(N = 775)
Non-TF
(N = 236)
Event
No. of
Events
*
Patients
with
Event
No.
Patients
at Risk
K-M Estimate
†
No. of
Events
*
Patients
with
Event
No.
Patients
at Risk
K-M Estimate
†
Point
Estimate
Standard
Error
Point
Estimate
Standard
Error
All-cause
death or
disabling
stroke at
2 years
151
128
612
16.8%
1.4%
78
64
162
27.7%
3.0%
All-cause
death at 2
year
108
108
630
14.2%
1.3%
58
58
168
25.2%
2.9%
Disabling
stroke at
2 years
43
39
612
5.3%
0.8%
20
20
162
9.1%
1.9%
*
Events with missing or incomplete onset dates are excluded from the analysis.
†
Kaplan-Meier estimates are provided at 2 years (day 730) and use the first event per patient. Events occurring after
730 days are not included in the analysis.