ENDURANCE Pagani DT Flashcards
Date end enrollment?
Q2 2012
Start of study?
Q2 2010
Primary Endpoint?
Survival @2 years free from disabling stroke (MRS >4@24 weeks post-stroke) & alive on original device, transplant or explant for recovery
Secondary end points?
- Adverse events INTERMACS
- KCCQ & EuroQoL
- NYHA Class & 6-min. Walk Test
N=?
446
HVAD=297
HMII=148
Baseline TR?
HVAD 11.8%
HMII 5.4%
Overall Primary Endpoint?
HMII 57.4%
HVAD 55%
Overall Primary Endpoint Sintered?
HMII 57.4%
HVAD 57.5%
Sintered N=?
Non-Sintered N=?
HMII N=?
Sintered N=200
Non-Sintered N=97
HMII N=148
Success?
HMII= 57.4%
HVAD= 57.5%
ADVERSE EVENTS
DIED?
HVAD 103 (34.7%)
HMII 39 (26.4%)
ADVERSE EVENTS
Malfunction Exchange Urgent Explant?
HMII 24 (16.2%)
HVAD 26 (8.8%)
ADVERSE EVENTS
Disabling Stroke?
HMII 0
HVAD 3 (1.0%)
Overall Survival?
HMII 67.6%
HVAD 60.2%
Overall Survival Sintered?
HMII 67.6%
HVAD 61.4%