Trial Outcomes & Findings for THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial (NCT NCT00530894)
NCT ID: NCT00530894
Last Updated: 2017-09-13
Results Overview
Death from any cause.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1057 participants
Primary outcome timeframe
1 Year
Results posted on
2017-09-13
Participant Flow
Participant milestones
| Measure |
High Risk: TAVR
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
348
|
351
|
179
|
179
|
|
Overall Study
COMPLETED
|
260
|
236
|
124
|
85
|
|
Overall Study
NOT COMPLETED
|
88
|
115
|
55
|
94
|
Reasons for withdrawal
| Measure |
High Risk: TAVR
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Overall Study
Death
|
84
|
89
|
55
|
89
|
|
Overall Study
Lost to Follow-up
|
1
|
3
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
23
|
0
|
5
|
|
Overall Study
Alive and censored prior to 1 year
|
2
|
0
|
0
|
0
|
Baseline Characteristics
THE PARTNER TRIAL: Placement of AoRTic TraNscathetER Valve Trial
Baseline characteristics by cohort
| Measure |
High Risk: TAVR
n=348 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=349 Participants
Surgical Valve Replacement
|
Inoperable TAVR
n=179 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 Participants
Medical management and/or balloon aortic valvuloplasty
|
Total
n=1055 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
High Risk
|
83.61 Years
STANDARD_DEVIATION 6.83 • n=99 Participants
|
84.52 Years
STANDARD_DEVIATION 6.37 • n=107 Participants
|
NA Years
STANDARD_DEVIATION NA • n=206 Participants
|
NA Years
STANDARD_DEVIATION NA • n=7 Participants
|
84.11 Years
STANDARD_DEVIATION 6.61 • n=31 Participants
|
|
Age, Continuous
Inoperable
|
NA Years
STANDARD_DEVIATION NA • n=99 Participants
|
NA Years
STANDARD_DEVIATION NA • n=107 Participants
|
83.12 Years
STANDARD_DEVIATION 8.60 • n=206 Participants
|
83.18 Years
STANDARD_DEVIATION 8.29 • n=7 Participants
|
83.18 Years
STANDARD_DEVIATION 8.43 • n=31 Participants
|
|
Sex: Female, Male
Female
|
147 Participants
n=99 Participants
|
151 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
95 Participants
n=7 Participants
|
490 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
201 Participants
n=99 Participants
|
198 Participants
n=107 Participants
|
82 Participants
n=206 Participants
|
84 Participants
n=7 Participants
|
565 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
11 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
32 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
White
|
324 Participants
n=99 Participants
|
328 Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
162 Participants
n=7 Participants
|
979 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
9 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
5 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
31 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
6 Participants
n=31 Participants
|
|
NYHA Class
High Risk Class II
|
20 Participants
n=99 Participants
|
21 Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
NA Participants
n=7 Participants
|
41 Participants
n=31 Participants
|
|
NYHA Class
Operable Class II
|
NA Participants
n=99 Participants
|
NA Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=31 Participants
|
|
NYHA Class
High Risk Class III or IV
|
328 Participants
n=99 Participants
|
328 Participants
n=107 Participants
|
NA Participants
n=206 Participants
|
NA Participants
n=7 Participants
|
656 Participants
n=31 Participants
|
|
NYHA Class
Inoperable Class III or IV
|
NA Participants
n=99 Participants
|
NA Participants
n=107 Participants
|
165 Participants
n=206 Participants
|
168 Participants
n=7 Participants
|
333 Participants
n=31 Participants
|
|
Quality of Life
High Risk KCCQ Overall
|
39.6 Score
STANDARD_DEVIATION 21.8 • n=99 Participants
|
44.5 Score
STANDARD_DEVIATION 21.8 • n=107 Participants
|
NA Score
STANDARD_DEVIATION NA • n=206 Participants
|
NA Score
STANDARD_DEVIATION NA • n=7 Participants
|
41.88 Score
STANDARD_DEVIATION 21.93 • n=31 Participants
|
|
Quality of Life
Inoperable KCCQ Overall
|
NA Score
STANDARD_DEVIATION NA • n=99 Participants
|
NA Score
STANDARD_DEVIATION NA • n=107 Participants
|
36.19 Score
STANDARD_DEVIATION 20.52 • n=206 Participants
|
34.44 Score
STANDARD_DEVIATION 20.14 • n=7 Participants
|
35.35 Score
STANDARD_DEVIATION 20.32 • n=31 Participants
|
|
Quality of Life
High Risk SF-12 Physical
|
29.6 Score
STANDARD_DEVIATION 7.6 • n=99 Participants
|
30.9 Score
STANDARD_DEVIATION 8.2 • n=107 Participants
|
NA Score
STANDARD_DEVIATION NA • n=206 Participants
|
NA Score
STANDARD_DEVIATION NA • n=7 Participants
|
30.2 Score
STANDARD_DEVIATION 7.9 • n=31 Participants
|
|
Quality of Life
Inoperable SF-12 Physical
|
NA Score
STANDARD_DEVIATION NA • n=99 Participants
|
NA Score
STANDARD_DEVIATION NA • n=107 Participants
|
28.23 Score
STANDARD_DEVIATION 7.73 • n=206 Participants
|
27.70 Score
STANDARD_DEVIATION 6.89 • n=7 Participants
|
28.0 Score
STANDARD_DEVIATION 7.23 • n=31 Participants
|
|
Quality of Life
High Risk SF-12 Mental
|
46.9 Score
STANDARD_DEVIATION 11.5 • n=99 Participants
|
47.6 Score
STANDARD_DEVIATION 10.7 • n=107 Participants
|
NA Score
STANDARD_DEVIATION NA • n=206 Participants
|
NA Score
STANDARD_DEVIATION NA • n=7 Participants
|
47.2 Score
STANDARD_DEVIATION 11.1 • n=31 Participants
|
|
Quality of Life
Inoperable SF-12 Mental
|
NA Score
STANDARD_DEVIATION NA • n=99 Participants
|
NA Score
STANDARD_DEVIATION NA • n=107 Participants
|
44.45 Score
STANDARD_DEVIATION 12.16 • n=206 Participants
|
45.23 Score
STANDARD_DEVIATION 11.03 • n=7 Participants
|
44.84 Score
STANDARD_DEVIATION 11.5 • n=31 Participants
|
|
STS Score
High Risk
|
11.8 Percentage
STANDARD_DEVIATION 3.3 • n=99 Participants
|
11.7 Percentage
STANDARD_DEVIATION 3.5 • n=107 Participants
|
NA Percentage
STANDARD_DEVIATION NA • n=206 Participants
|
NA Percentage
STANDARD_DEVIATION NA • n=7 Participants
|
11.75 Percentage
STANDARD_DEVIATION 3.40 • n=31 Participants
|
|
STS Score
Inoperable
|
NA Percentage
STANDARD_DEVIATION NA • n=99 Participants
|
NA Percentage
STANDARD_DEVIATION NA • n=107 Participants
|
11.2 Percentage
STANDARD_DEVIATION 5.8 • n=206 Participants
|
11.9 Percentage
STANDARD_DEVIATION 4.8 • n=7 Participants
|
11.51 Percentage
STANDARD_DEVIATION 5.34 • n=31 Participants
|
PRIMARY outcome
Timeframe: 1 YearDeath from any cause.
Outcome measures
| Measure |
High Risk: TAVR
n=348 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=351 Participants
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=179 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 Participants
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Death
|
84 participants
|
89 participants
|
55 participants
|
89 participants
|
PRIMARY outcome
Timeframe: duration of studyPopulation: Composite of Death and recurrence hospitalization was not a primary outcome for the High Risk groups.
Death from any cause or repeat hospitalization after intervention.
Outcome measures
| Measure |
High Risk: TAVR
n=179 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=179 Participants
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Composite of Death and Recurrence Hospitalization.
|
76 participants
|
126 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 1 yearPopulation: Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
NYHA classification change from baseline to 1 year visit. NYHA provides a way of classifying the extent of heart failure. New York Heart Association (NYHA) is a 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 (I) as no limitations and the highest (IV) unable to carry on any physical activity without discomfort.
Outcome measures
| Measure |
High Risk: TAVR
n=334 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=314 Participants
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=172 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=167 Participants
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Functional Change of NYHA
|
2.50 Units on scale
Interval 2.35 to 2.65
|
2.60 Units on scale
Interval 2.45 to 2.76
|
2.88 Units on scale
Interval 2.7 to 3.07
|
3.92 Units on scale
Interval 3.73 to 4.11
|
SECONDARY outcome
Timeframe: 1 yearNumber of participants with MACCE definition includes death, myocardial infarction (MI), stroke and renal failure
Outcome measures
| Measure |
High Risk: TAVR
n=348 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=351 Participants
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=179 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 Participants
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Number of Participants With Major Adverse Cardiac and Cerebro-vascular Events (MACCE)
|
93 participants
|
97 participants
|
61 participants
|
93 participants
|
SECONDARY outcome
Timeframe: 1 yearTotal hospital days from the index procedure or randomization into control arm to one year post procedure or randomization.
Outcome measures
| Measure |
High Risk: TAVR
n=348 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=351 Participants
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=179 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 Participants
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Total Hospital Days From the Index Procedure
|
17.42 Days
Standard Deviation 19.05
|
20.14 Days
Standard Deviation 23.85
|
25.24 Days
Standard Deviation 21.11
|
17.04 Days
Standard Deviation 33.46
|
SECONDARY outcome
Timeframe: Baseline and 1 YearPopulation: Note that the number of participants analyzed is different from that in the participant flow as there was some missing data.
The QOL questionnaire consisted of: Kansas City Cardiomyopathy (KCCQ), The Medical Outcomes Study Short-Form 12 (SF-12) - physical and metal states. KCCQ scores are on a range of 0-100, in which 100 reflects the best health status and 0 reflects the worst health status. SF-12 questionnaire was used in which 100 reflects the best health status and 0 reflects the worst health status.
Outcome measures
| Measure |
High Risk: TAVR
n=348 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=351 Participants
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=179 Participants
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 Participants
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
Change in Quality of Life (QOL) From Baseline to 1 Year
SF-12 Physical
|
36.3 Units on a scale
Standard Deviation 11.0
|
36.9 Units on a scale
Standard Deviation 10.4
|
34.85 Units on a scale
Standard Deviation 11.13
|
29.68 Units on a scale
Standard Deviation 6.47
|
|
Change in Quality of Life (QOL) From Baseline to 1 Year
SF-12 Mental
|
52.0 Units on a scale
Standard Deviation 10.1
|
52.9 Units on a scale
Standard Deviation 9.7
|
53.31 Units on a scale
Standard Deviation 10.00
|
46.59 Units on a scale
Standard Deviation 11.68
|
|
Change in Quality of Life (QOL) From Baseline to 1 Year
KCCQ Overall
|
70.0 Units on a scale
Standard Deviation 22.4
|
71.1 Units on a scale
Standard Deviation 23.0
|
69.41 Units on a scale
Standard Deviation 25.37
|
46.98 Units on a scale
Standard Deviation 24.59
|
Adverse Events
High Risk: TAVR
Serious events: 228 serious events
Other events: 230 other events
Deaths: 0 deaths
High Risk: SAVR
Serious events: 238 serious events
Other events: 217 other events
Deaths: 0 deaths
Inoperable: TAVR
Serious events: 134 serious events
Other events: 140 other events
Deaths: 0 deaths
Inoperable: Medical Therapy
Serious events: 151 serious events
Other events: 103 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
High Risk: TAVR
n=348 participants at risk
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=351 participants at risk
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=179 participants at risk
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 participants at risk
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
General disorders
Other
|
26.1%
91/348 • Number of events 127 • 1 Year
|
24.5%
86/351 • Number of events 129 • 1 Year
|
33.5%
60/179 • Number of events 98 • 1 Year
|
38.0%
68/179 • Number of events 105 • 1 Year
|
|
Infections and infestations
Infection (including Endocarditis)
|
20.1%
70/348 • Number of events 96 • 1 Year
|
16.8%
59/351 • Number of events 74 • 1 Year
|
19.6%
35/179 • Number of events 53 • 1 Year
|
16.8%
30/179 • Number of events 38 • 1 Year
|
|
Cardiac disorders
CHF
|
14.4%
50/348 • Number of events 73 • 1 Year
|
14.5%
51/351 • Number of events 64 • 1 Year
|
13.4%
24/179 • Number of events 32 • 1 Year
|
43.6%
78/179 • Number of events 102 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Event
|
13.2%
46/348 • Number of events 66 • 1 Year
|
17.4%
61/351 • Number of events 76 • 1 Year
|
14.0%
25/179 • Number of events 28 • 1 Year
|
11.7%
21/179 • Number of events 23 • 1 Year
|
|
Vascular disorders
Bleeding event
|
9.2%
32/348 • Number of events 33 • 1 Year
|
10.8%
38/351 • Number of events 42 • 1 Year
|
12.8%
23/179 • Number of events 26 • 1 Year
|
7.3%
13/179 • Number of events 14 • 1 Year
|
|
Nervous system disorders
Neurological event (including TIA stroke and psychomotor deficit)
|
9.5%
33/348 • Number of events 33 • 1 Year
|
6.8%
24/351 • Number of events 28 • 1 Year
|
13.4%
24/179 • Number of events 28 • 1 Year
|
3.9%
7/179 • Number of events 8 • 1 Year
|
|
Cardiac disorders
Arrhythmia
|
9.2%
32/348 • Number of events 34 • 1 Year
|
10.8%
38/351 • Number of events 44 • 1 Year
|
12.3%
22/179 • Number of events 24 • 1 Year
|
13.4%
24/179 • Number of events 32 • 1 Year
|
|
Gastrointestinal disorders
Gastro-Intestinal Event
|
6.3%
22/348 • Number of events 24 • 1 Year
|
4.6%
16/351 • Number of events 18 • 1 Year
|
5.0%
9/179 • Number of events 9 • 1 Year
|
3.9%
7/179 • Number of events 10 • 1 Year
|
|
Vascular disorders
Hemorrhagic/Vascular event
|
6.0%
21/348 • Number of events 22 • 1 Year
|
5.7%
20/351 • Number of events 20 • 1 Year
|
12.8%
23/179 • Number of events 24 • 1 Year
|
5.0%
9/179 • Number of events 9 • 1 Year
|
|
Renal and urinary disorders
Renal failure
|
5.7%
20/348 • Number of events 21 • 1 Year
|
7.4%
26/351 • Number of events 29 • 1 Year
|
6.1%
11/179 • Number of events 12 • 1 Year
|
6.7%
12/179 • Number of events 12 • 1 Year
|
|
Investigations
Abnormal Lab Values
|
4.6%
16/348 • Number of events 19 • 1 Year
|
4.3%
15/351 • Number of events 17 • 1 Year
|
6.7%
12/179 • Number of events 17 • 1 Year
|
6.1%
11/179 • Number of events 17 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
4.3%
15/348 • Number of events 16 • 1 Year
|
4.0%
14/351 • Number of events 15 • 1 Year
|
1.7%
3/179 • Number of events 3 • 1 Year
|
2.8%
5/179 • Number of events 7 • 1 Year
|
|
Vascular disorders
Hypotension
|
3.2%
11/348 • Number of events 11 • 1 Year
|
4.0%
14/351 • Number of events 14 • 1 Year
|
5.0%
9/179 • Number of events 9 • 1 Year
|
2.2%
4/179 • Number of events 4 • 1 Year
|
|
Cardiac disorders
Conduction defects
|
3.2%
11/348 • Number of events 11 • 1 Year
|
3.4%
12/351 • Number of events 12 • 1 Year
|
2.8%
5/179 • Number of events 5 • 1 Year
|
2.2%
4/179 • Number of events 4 • 1 Year
|
|
Renal and urinary disorders
Renal insufficiency
|
2.3%
8/348 • Number of events 8 • 1 Year
|
2.3%
8/351 • Number of events 8 • 1 Year
|
1.1%
2/179 • Number of events 2 • 1 Year
|
1.7%
3/179 • Number of events 3 • 1 Year
|
|
Vascular disorders
Angina
|
2.0%
7/348 • Number of events 9 • 1 Year
|
1.1%
4/351 • Number of events 5 • 1 Year
|
1.1%
2/179 • Number of events 4 • 1 Year
|
2.2%
4/179 • Number of events 5 • 1 Year
|
|
General disorders
Device embolization
|
1.7%
6/348 • Number of events 6 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.00%
0/179 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Cardiac disorders
Syncope
|
1.7%
6/348 • Number of events 6 • 1 Year
|
1.4%
5/351 • Number of events 5 • 1 Year
|
1.7%
3/179 • Number of events 4 • 1 Year
|
3.4%
6/179 • Number of events 8 • 1 Year
|
|
Cardiac disorders
Aortic insufficiency without paravalvular leak
|
1.1%
4/348 • Number of events 4 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
General disorders
Fever
|
1.1%
4/348 • Number of events 4 • 1 Year
|
0.00%
0/351 • 1 Year
|
1.1%
2/179 • Number of events 3 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
|
Vascular disorders
Ischemia
|
1.1%
4/348 • Number of events 4 • 1 Year
|
0.57%
2/351 • Number of events 2 • 1 Year
|
1.1%
2/179 • Number of events 2 • 1 Year
|
1.1%
2/179 • Number of events 2 • 1 Year
|
|
Vascular disorders
MI
|
1.1%
4/348 • Number of events 4 • 1 Year
|
1.1%
4/351 • Number of events 4 • 1 Year
|
2.8%
5/179 • Number of events 5 • 1 Year
|
3.4%
6/179 • Number of events 6 • 1 Year
|
|
Vascular disorders
Hematoma
|
0.86%
3/348 • Number of events 3 • 1 Year
|
0.57%
2/351 • Number of events 2 • 1 Year
|
1.1%
2/179 • Number of events 2 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
|
Injury, poisoning and procedural complications
Perforation or damage to myocardium
|
0.86%
3/348 • Number of events 3 • 1 Year
|
0.28%
1/351 • Number of events 1 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Vascular disorders
Thromboembolism
|
1.1%
4/348 • Number of events 4 • 1 Year
|
0.85%
3/351 • Number of events 4 • 1 Year
|
1.7%
3/179 • Number of events 3 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Cardiac disorders
Pericardial effusion
|
0.57%
2/348 • Number of events 2 • 1 Year
|
0.28%
1/351 • Number of events 2 • 1 Year
|
0.00%
0/179 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
General disorders
Device migration
|
0.29%
1/348 • Number of events 1 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.00%
0/179 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Metabolism and nutrition disorders
Electrolyte Imbalance
|
0.29%
1/348 • Number of events 1 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.00%
0/179 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
General disorders
Perivalvular leak
|
0.29%
1/348 • Number of events 1 • 1 Year
|
0.00%
0/351 • 1 Year
|
1.1%
2/179 • Number of events 2 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Cardiac disorders
Valve stenosis
|
0.29%
1/348 • Number of events 1 • 1 Year
|
0.85%
3/351 • Number of events 3 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
18.4%
33/179 • Number of events 42 • 1 Year
|
|
Blood and lymphatic system disorders
Hemolysis
|
0.00%
0/348 • 1 Year
|
0.28%
1/351 • Number of events 1 • 1 Year
|
0.00%
0/179 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.00%
0/348 • 1 Year
|
0.28%
1/351 • Number of events 1 • 1 Year
|
1.7%
3/179 • Number of events 4 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Cardiac disorders
Mitral insufficiency
|
0.29%
1/348 • Number of events 1 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.00%
0/179 • 1 Year
|
0.00%
0/179 • 1 Year
|
|
Injury, poisoning and procedural complications
Access site nerve injury
|
0.00%
0/348 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
0.00%
0/179 • 1 Year
|
Other adverse events
| Measure |
High Risk: TAVR
n=348 participants at risk
Edwards SAPIEN Transcatheter Heart Valve
|
High Risk: SAVR
n=351 participants at risk
Surgical Aortic Valve Replacement
|
Inoperable: TAVR
n=179 participants at risk
Edwards SAPIEN Transcatheter Heart Valve
|
Inoperable: Medical Therapy
n=179 participants at risk
Medical management and/or balloon aortic valvuloplasty
|
|---|---|---|---|---|
|
General disorders
Other
|
38.2%
133/348 • Number of events 242 • 1 Year
|
35.3%
124/351 • Number of events 219 • 1 Year
|
48.6%
87/179 • Number of events 204 • 1 Year
|
24.6%
44/179 • Number of events 80 • 1 Year
|
|
Investigations
Abnormal Lab Values
|
24.1%
84/348 • Number of events 128 • 1 Year
|
23.9%
84/351 • Number of events 136 • 1 Year
|
28.5%
51/179 • Number of events 86 • 1 Year
|
15.6%
28/179 • Number of events 46 • 1 Year
|
|
Infections and infestations
Infection (including Endocarditis)
|
17.2%
60/348 • Number of events 80 • 1 Year
|
16.5%
58/351 • Number of events 69 • 1 Year
|
24.6%
44/179 • Number of events 57 • 1 Year
|
19.0%
34/179 • Number of events 52 • 1 Year
|
|
Cardiac disorders
Arrhythmia
|
12.4%
43/348 • Number of events 49 • 1 Year
|
22.2%
78/351 • Number of events 88 • 1 Year
|
14.5%
26/179 • Number of events 30 • 1 Year
|
8.9%
16/179 • Number of events 18 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Event
|
9.5%
33/348 • Number of events 38 • 1 Year
|
9.1%
32/351 • Number of events 35 • 1 Year
|
8.4%
15/179 • Number of events 18 • 1 Year
|
5.6%
10/179 • Number of events 12 • 1 Year
|
|
Vascular disorders
Bleeding event
|
7.2%
25/348 • Number of events 27 • 1 Year
|
6.3%
22/351 • Number of events 25 • 1 Year
|
8.9%
16/179 • Number of events 21 • 1 Year
|
3.9%
7/179 • Number of events 7 • 1 Year
|
|
Vascular disorders
Hemorrhagic/Vascular event
|
7.2%
25/348 • Number of events 26 • 1 Year
|
2.0%
7/351 • Number of events 7 • 1 Year
|
11.2%
20/179 • Number of events 25 • 1 Year
|
1.7%
3/179 • Number of events 3 • 1 Year
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
6.9%
24/348 • Number of events 25 • 1 Year
|
13.4%
47/351 • Number of events 52 • 1 Year
|
8.4%
15/179 • Number of events 17 • 1 Year
|
3.9%
7/179 • Number of events 7 • 1 Year
|
|
Gastrointestinal disorders
Gastro-Intestinal Event
|
6.3%
22/348 • Number of events 29 • 1 Year
|
6.0%
21/351 • Number of events 22 • 1 Year
|
7.3%
13/179 • Number of events 18 • 1 Year
|
3.9%
7/179 • Number of events 9 • 1 Year
|
|
Cardiac disorders
CHF
|
5.2%
18/348 • Number of events 18 • 1 Year
|
2.0%
7/351 • Number of events 7 • 1 Year
|
4.5%
8/179 • Number of events 8 • 1 Year
|
8.4%
15/179 • Number of events 17 • 1 Year
|
|
Vascular disorders
Hypotension
|
5.5%
19/348 • Number of events 19 • 1 Year
|
4.6%
16/351 • Number of events 17 • 1 Year
|
10.6%
19/179 • Number of events 22 • 1 Year
|
4.5%
8/179 • Number of events 9 • 1 Year
|
|
Vascular disorders
Hematoma
|
5.2%
18/348 • Number of events 18 • 1 Year
|
0.57%
2/351 • Number of events 2 • 1 Year
|
13.4%
24/179 • Number of events 28 • 1 Year
|
4.5%
8/179 • Number of events 8 • 1 Year
|
|
Vascular disorders
Hypertension
|
0.00%
0/348 • 1 Year
|
0.00%
0/351 • 1 Year
|
6.7%
12/179 • Number of events 12 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
|
Cardiac disorders
Valve stenosis
|
0.00%
0/348 • 1 Year
|
0.00%
0/351 • 1 Year
|
0.56%
1/179 • Number of events 1 • 1 Year
|
6.1%
11/179 • Number of events 11 • 1 Year
|
|
Renal and urinary disorders
Renal insufficiency
|
0.00%
0/348 • 1 Year
|
0.00%
0/351 • 1 Year
|
5.6%
10/179 • Number of events 10 • 1 Year
|
1.7%
3/179 • Number of events 3 • 1 Year
|
|
Nervous system disorders
Neurological event (including TIA stroke and psychomotor deficit)
|
0.00%
0/348 • 1 Year
|
0.00%
0/351 • 1 Year
|
5.6%
10/179 • Number of events 11 • 1 Year
|
5.6%
10/179 • Number of events 10 • 1 Year
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Site cannot publish or present on overall study results not yet published. PI may publish his own clinical study data subject to EW review prior submission or presentation, but data analyses of site-specific results can occur only in intervals as specified in the CSA. Publication of site-specific results cannot include claims of device safety and effectiveness and requires EW review.
- Publication restrictions are in place
Restriction type: OTHER