Trial Outcomes & Findings for The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B (NCT NCT02184442)

NCT ID: NCT02184442

Last Updated: 2018-09-25

Results Overview

All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year

Recruitment status

COMPLETED

Study phase

Target enrollment

560 participants

Primary outcome timeframe

1 Year

Results posted on

2018-09-25

Participant Flow

Subjects were screened and enrolled at 53 sites in the US and Canada

Participant milestones

Participant milestones
Measure	TAVR - SAPIEN XT TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Overall Study STARTED	284	276
Overall Study As-Treated	282	271
Overall Study Valve-Implant	280	263
Overall Study COMPLETED	220	200
Overall Study NOT COMPLETED	64	76

Reasons for withdrawal

Reasons for withdrawal
Measure	TAVR - SAPIEN XT TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Overall Study Death	61	65
Overall Study Withdrawal by Subject	3	11

Baseline Characteristics

The PARTNER II Trial: Placement of AoRTic TraNscathetER Valves - PII B

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TAVR - SAPIEN XT n=284 Participants TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN n=276 Participants TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	Total n=560 Participants Total of all reporting groups
Age, Continuous	84.0 Years STANDARD_DEVIATION 8.65 • n=5 Participants	84.6 Years STANDARD_DEVIATION 8.61 • n=7 Participants	84.3 Years STANDARD_DEVIATION 8.63 • n=5 Participants
Sex: Female, Male Female	143 Participants n=5 Participants	134 Participants n=7 Participants	277 Participants n=5 Participants
Sex: Female, Male Male	141 Participants n=5 Participants	142 Participants n=7 Participants	283 Participants n=5 Participants
STS Score	10.3 units on a scale STANDARD_DEVIATION 5.38 • n=5 Participants	11.0 units on a scale STANDARD_DEVIATION 5.71 • n=7 Participants	10.6 units on a scale STANDARD_DEVIATION 5.55 • n=5 Participants
NYHA Class III/IV	275 Participants n=5 Participants	265 Participants n=7 Participants	540 Participants n=5 Participants
Coronary Artery Disease	186 Participants n=5 Participants	186 Participants n=7 Participants	372 Participants n=5 Participants
Frailty	168 Participants n=5 Participants	166 Participants n=7 Participants	334 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Year

All-Cause Mortality and/or Major Stroke and/or Rehospitalization at 1 Year

Outcome measures

Outcome measures
Measure	TAVR - SAPIEN XT n=284 Participants TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN n=276 Participants TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Number of Participants With All-Cause Mortality and/or Major Stroke and/or Rehospitalization	105 participants	102 participants

SECONDARY outcome

Timeframe: Baseline and 1 Year

Population: Please note that all the patients were not available for a NYHA functional assessment

New York Heart Association (NYHA), functional classification of heart failure based on how much a patient is limited during physical activity. The rating ranges from I - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.

Outcome measures

Outcome measures
Measure	TAVR - SAPIEN XT n=204 Participants TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN n=192 Participants TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
NYHA Classification - Change From Baseline	-1.8 Units on a scale Standard Deviation 0.92	-1.7 Units on a scale Standard Deviation 0.91

SECONDARY outcome

Timeframe: 1 Year

Population: Please note that all the valve-implant population do not have echo data.

Total aortic regurgitation was assessed by the core lab as 'Grade 0' = None, 'Grade 1+' = Trace, 'Grade 2+' = Mild, 'Grade 3+' = Moderate, and 'Grade 4+' = Severe. Total regurgitation at one year was analyzed in the valve implant population.

Outcome measures

Outcome measures
Measure	TAVR - SAPIEN XT n=172 Participants TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN n=155 Participants TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Total Aortic Regurgitation - Change From Baseline	0.2 Grade Standard Deviation 1.38	0.1 Grade Standard Deviation 1.23

SECONDARY outcome

Timeframe: 1 Year

Population: Valve Implant Population; Please note that echo data was not available for all patients.

Outcome measures

Outcome measures
Measure	TAVR - SAPIEN XT n=163 Participants TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN n=149 Participants TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Effective Orifice Area - Change From Baseline	0.9 cm^2 Standard Deviation 0.41	0.9 cm^2 Standard Deviation 0.38

Adverse Events

TAVR - SAPIEN XT

Serious events: 196 serious events

Other events: 211 other events

Deaths: 10 deaths

TAVR - SAPIEN

Serious events: 180 serious events

Other events: 195 other events

Deaths: 12 deaths

Serious adverse events

Other adverse events

Additional Information

Tenley Koepnick

Edwards Life Sciences

Phone: 949-250-6504

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER

Measure	TAVR - SAPIEN XT n=280 participants at risk TAVR (transaortic valve replacement) with SAPIEN XT TAVR Implantation with SAPIEN XT: Inoperable operable patients requiring the transcatheter aortic heart valve replacement	TAVR - SAPIEN n=263 participants at risk TAVR (transaortic valve replacement) with SAPIEN is the control arm TAVR Implantation with SAPIEN: Inoperable operable patients requiring the transcatheter aortic heart valve replacement
Investigations Abnormal Lab Value	17.5% 49/280 • Number of events 75 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	19.8% 52/263 • Number of events 77 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Blood and lymphatic system disorders Anemia/Hemolytic Anemia	12.5% 35/280 • Number of events 45 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	13.7% 36/263 • Number of events 39 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Cardiac disorders Arrhythmia/Conduction System Injury (Defect)	16.4% 46/280 • Number of events 52 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	15.6% 41/263 • Number of events 51 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Psychiatric disorders Confusion	2.9% 8/280 • Number of events 8 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.1% 16/263 • Number of events 18 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Ear and labyrinth disorders Edema	3.9% 11/280 • Number of events 11 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.8% 18/263 • Number of events 19 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Injury, poisoning and procedural complications Fall	4.3% 12/280 • Number of events 14 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	7.2% 19/263 • Number of events 21 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Gastrointestinal disorders Gastro Intestinal Event	6.8% 19/280 • Number of events 21 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	7.2% 19/263 • Number of events 22 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Vascular disorders Hemorrhage	10.0% 28/280 • Number of events 33 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	11.4% 30/263 • Number of events 34 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Vascular disorders Hypotension	4.3% 12/280 • Number of events 12 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.5% 17/263 • Number of events 17 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Injury, poisoning and procedural complications Non Structural Dysfunction	4.6% 13/280 • Number of events 14 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.7% 15/263 • Number of events 16 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Respiratory, thoracic and mediastinal disorders Pulmonary Effusion	8.9% 25/280 • Number of events 29 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.8% 18/263 • Number of events 21 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Renal and urinary disorders Renal Insufficiency or Renal Failure	7.9% 22/280 • Number of events 23 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.3% 14/263 • Number of events 16 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Respiratory, thoracic and mediastinal disorders Respiratory Infection	5.0% 14/280 • Number of events 17 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.3% 14/263 • Number of events 14 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Blood and lymphatic system disorders Thrombocytopenia	5.7% 16/280 • Number of events 17 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.8% 18/263 • Number of events 18 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Renal and urinary disorders Urinary Tract Infection	10.0% 28/280 • Number of events 31 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	13.3% 35/263 • Number of events 45 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).
General disorders Other	28.2% 79/280 • Number of events 105 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).	33.1% 87/263 • Number of events 145 • Adverse event data are currently available and reported for all events at 1 year were reported at the time of database lock. All adverse events are site reported Only Valve-Implanted patients are reported for all adverse events (except for mortality).