Trial Outcomes & Findings for PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7 (NCT NCT03222141)
NCT ID: NCT03222141
Last Updated: 2021-05-12
Results Overview
The composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
583 participants
Primary outcome timeframe
30 Days
Results posted on
2021-05-12
Participant Flow
Participant milestones
| Measure |
SAPIEN 3™ Valve
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
|
|---|---|
|
Overall Study
STARTED
|
583
|
|
Overall Study
COMPLETED
|
565
|
|
Overall Study
NOT COMPLETED
|
18
|
Reasons for withdrawal
| Measure |
SAPIEN 3™ Valve
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
|
|---|---|
|
Overall Study
Death
|
15
|
|
Overall Study
Lost to Follow-up
|
3
|
Baseline Characteristics
PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - High Risk and Nested Registry 7
Baseline characteristics by cohort
| Measure |
SAPIEN 3™ Valve
n=583 Participants
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
|
|---|---|
|
Age, Continuous
|
82.6 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
245 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
338 Participants
n=5 Participants
|
|
STS score
|
8.6 units on a scale
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
NYHA III/IV
|
525 Participants
n=5 Participants
|
|
Coronary artery disease
|
444 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 30 DaysThe composite rate of all-cause mortality, all stroke, and AI ≥ moderate for patients deemed as 'high risk' using the Edwards SAPIEN 3 transcatheter heart valve (THV).
Outcome measures
| Measure |
SAPIEN 3™ Valve
n=583 Participants
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
|
|---|---|
|
The Composite Rate of All-cause Mortality, All Stroke, and AI ≥ Moderate
|
6.7 percentage of patients
Interval 5.1 to 8.6
|
SECONDARY outcome
Timeframe: 30 DaysThe rate of major vascular complications at 30 days post implantation
Outcome measures
| Measure |
SAPIEN 3™ Valve
n=583 Participants
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
|
|---|---|
|
Number of Participants With Major Vascular Complications
|
29 Participants
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Echo data was available only for 532 patients.
The proportion of patients with aortic insufficiency ≥ moderate at 30 days.
Outcome measures
| Measure |
SAPIEN 3™ Valve
n=532 Participants
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation
|
|---|---|
|
Number of Participants With Aortic Insufficiency at 30 Days
|
16 Participants
|
Adverse Events
SAPIEN 3™ THV
Serious events: 232 serious events
Other events: 397 other events
Deaths: 13 deaths
Serious adverse events
| Measure |
SAPIEN 3™ THV
n=583 participants at risk
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation.
High risk cohort
|
|---|---|
|
Investigations
Any Adverse Event
|
1.0%
6/583 • Number of events 7 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Aortic root rupture
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Dissection
|
0.86%
5/583 • Number of events 5 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Distal embolization (noncerebral) from vascular sou
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Failure of percutaneous access site closure
|
0.86%
5/583 • Number of events 5 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Hematoma
|
0.86%
5/583 • Number of events 5 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Other
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Perforation
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Pseudoaneurysm
|
0.69%
4/583 • Number of events 4 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Stenosis
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Thoracic aortic dissection
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Access site and access related vascular injury - Ventricular rupture (Apical rupture)
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Blood and lymphatic system disorders
Anemia/Hemolytic anemia
|
0.86%
5/583 • Number of events 5 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Angina/Cardiac chest pain
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction
|
0.86%
5/583 • Number of events 5 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Aortic insufficiency/Regurgitation non valvular cause
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Arrhythmia/Conduction system injury (defect)
|
18.0%
105/583 • Number of events 108 • the adverse event data was collected over 30 days
|
|
General disorders
Bleeding - Hemorrhage
|
7.0%
41/583 • Number of events 44 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Cardiac arrest
|
1.4%
8/583 • Number of events 9 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Cardiac tamponade
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Cardiogenic shock
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Psychiatric disorders
Delirium
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Device embolization
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Device migration/malposition requiring intervention
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Nervous system disorders
Encephalopathy
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Metabolism and nutrition disorders
Exercise intolerance or weakness
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic
|
1.7%
10/583 • Number of events 10 • the adverse event data was collected over 30 days
|
|
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Heart failure/CHF/Low output failure
|
5.0%
29/583 • Number of events 31 • the adverse event data was collected over 30 days
|
|
Vascular disorders
Hypertension
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Vascular disorders
Hypotension
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Infections and infestations
Infection - Access site infection
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Infections and infestations
Infection - Bacteremia
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Infections and infestations
Infection - Other
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Infections and infestations
Infection - Respiratory infection
|
1.2%
7/583 • Number of events 7 • the adverse event data was collected over 30 days
|
|
Infections and infestations
Infection - Sepsis
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Renal and urinary disorders
Infection - Urinary tract infection
|
1.0%
6/583 • Number of events 6 • the adverse event data was collected over 30 days
|
|
Investigations
Ischemia
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
MI
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Psychiatric disorders
Mental state change (not neurological) - Confusion
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Psychiatric disorders
Mental state change (not neurological) - Depression
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Miscellaneous - Cancer
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Miscellaneous - Fall
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
General disorders
Miscellaneous - Other
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Injury, poisoning and procedural complications
Musculoskeletal - Fracture
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal - Pain
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Nervous system disorders
Neurological - Dysphasia/Aphasia
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Nervous system disorders
Neurological - Hemiparesis (One sided body weakness)
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Nervous system disorders
Neurological - Ischemic stroke
|
1.2%
7/583 • Number of events 7 • the adverse event data was collected over 30 days
|
|
Nervous system disorders
Neurological - Sensory loss on one side of body
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Nervous system disorders
Neurological - TIA
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Investigations
Neurological - Undetermined stroke
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Renal and urinary disorders
Renal insufficiency or renal failure
|
2.6%
15/583 • Number of events 15 • the adverse event data was collected over 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Dyspnea
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Other
|
0.69%
4/583 • Number of events 4 • the adverse event data was collected over 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pneumothorax
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pulmonary effusion
|
2.9%
17/583 • Number of events 17 • the adverse event data was collected over 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory event - Respiratory failure
|
2.2%
13/583 • Number of events 13 • the adverse event data was collected over 30 days
|
|
Vascular disorders
Syncope
|
0.69%
4/583 • Number of events 4 • the adverse event data was collected over 30 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.51%
3/583 • Number of events 3 • the adverse event data was collected over 30 days
|
|
Surgical and medical procedures
Thromboembolic event
|
0.34%
2/583 • Number of events 2 • the adverse event data was collected over 30 days
|
|
Investigations
Unknown cause of death
|
0.17%
1/583 • Number of events 1 • the adverse event data was collected over 30 days
|
|
Vascular disorders
Vascular complication - Non-access related
|
0.69%
4/583 • Number of events 4 • the adverse event data was collected over 30 days
|
|
Investigations
Other
|
0.69%
4/583 • Number of events 4 • the adverse event data was collected over 30 days
|
Other adverse events
| Measure |
SAPIEN 3™ THV
n=583 participants at risk
TAVR Implantation of the THV Prosthesis: Patients with TAVR implantation.
High risk cohort
|
|---|---|
|
Investigations
Abnormal lab value
|
12.2%
71/583 • Number of events 82 • the adverse event data was collected over 30 days
|
|
Blood and lymphatic system disorders
Anemia/Hemolytic anemia
|
9.3%
54/583 • Number of events 54 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Arrhythmia/Conduction system injury (defect)
|
22.0%
128/583 • Number of events 146 • the adverse event data was collected over 30 days
|
|
Vascular disorders
Bleeding - Hemorrhage
|
20.2%
118/583 • Number of events 126 • the adverse event data was collected over 30 days
|
|
Cardiac disorders
Heart failure/CHF/Low output failure
|
7.0%
41/583 • Number of events 41 • the adverse event data was collected over 30 days
|
|
Renal and urinary disorders
Renal insufficiency or renal failure
|
9.3%
54/583 • Number of events 54 • the adverse event data was collected over 30 days
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
6.9%
40/583 • Number of events 40 • the adverse event data was collected over 30 days
|
|
Investigations
Other
|
7.0%
41/583 • Number of events 45 • the adverse event data was collected over 30 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place