Edwards SAPIEN 3 - All-Cause Death and All Stroke at 1 Year

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The Kaplan-Meier (KM) estimates for all-cause death and all stroke at 1 year for the PIIS3i cohort and the
PIIA-SAVR cohort are provided in Table 19, as well as Figures 20 and 21, respectively.
Table 19:
All-Cause Death and All Stroke at 1 Year
(VI Population)
SAPIEN 3 Valve
(N= 1069)
PIIA-SAVR
(N = 936)
Propensity Score
Quintile Pooled
Proportion Difference
(ATT Method
†
)
Endpoints
Observed
Event Rate
Kaplan-Meier Event
Rate
*
Observed
Event Rate
Kaplan-Meier Event Rate
*
Point
Estimate
Standard
Error
Point
Estimate
Standard
Error
All-cause death
at 1 year
7.0% 7.1% 0.79% 12.4% 12.6% 1.09% -5.2%
All stroke at 1
year
4.5% 4.6% 0.65% 7.9% 8.1% 0.91% -3.5%
*
Kaplan-Meier estimates were calculated at 365 days and included only the first event for each patient.
Events
occurring after 365 days were not included in this analysis.
†
ATT: average treatment effect on the treated