PARTNER 3 Trial: Safety and Effectiveness of the SAPIEN 3 Transcatheter Heart Valve in Low Risk Patients With Aortic Stenosis (P3)

• ClinicalTrials.gov Identifier: NCT02675114
• Recruitment Status: Active, not recruiting
• First Posted: February 5, 2016
• Results First Posted: December 2, 2021
• Last Update Posted: November 30, 2023
• Sponsor: Edwards Lifesciences
• Information provided by (Responsible Party): Edwards Lifesciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Aortic Stenosis
• Interventions: Procedure: SAVR; Device: SAPIEN 3 THV
• Enrollment: 1000

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Period Title: Overall Study
Started	497	503
As Treated	454	496
Valve Implant	453	495
Completed	424	490
Not Completed	73	13

Baseline Characteristics

Arm/Group Title		Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)	Total
Arm/Group Description		SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System	Total of all reporting groups
Overall Number of Baseline Participants		454	496	950
Baseline Analysis Population Description		As Treated
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	454 participants	496 participants	950 participants
		73.6 (6.08)	73.3 (5.83)	73.4 (5.95)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	454 participants	496 participants	950 participants
	Female	131 28.9%	161 32.5%	292 30.7%
	Male	323 71.1%	335 67.5%	658 69.3%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	454 participants	496 participants	950 participants
Asian		9 2.0%	8 1.6%	17 1.8%
Black or African American		12 2.6%	15 3.0%	27 2.8%
Hispanic or Latino		9 2.0%	7 1.4%	16 1.7%
Native Hawaiian or other Pacific Islander		4 0.9%	5 1.0%	9 0.9%
White		409 90.1%	458 92.3%	867 91.3%
Multiple		6 1.3%	3 0.6%	9 0.9%
Other		4 0.9%	0 0.0%	4 0.4%
Unknown		1 0.2%	0 0.0%	1 0.1%

Outcome Measures

1. Primary Outcome

Title	All-cause Mortality, All Stroke, and Rehospitalization (Valve-related or Procedure-related and Including Heart Failure)
Description	Number of patients that had any of these events
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description:	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Overall Number of Participants Analyzed	454	496
Measure Type: Count of Participants; Unit of Measure: Participants
	68	42

2. Secondary Outcome

Title	New Onset Atrial Fibrillation
Description	Number of patients with this event
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

As Treated. Patients who had atrial fibrillation prior to the procedure were excluded from the analysis.

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description:	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Overall Number of Participants Analyzed	369	417
Measure Type: Count of Participants; Unit of Measure: Participants
	145	21

3. Secondary Outcome

Title	Length of Index Hospitalization
Description	Number of days from index procedure to discharge
Time Frame	Discharge (expected average of 7 days)

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description:	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Overall Number of Participants Analyzed	454	496
Mean (Standard Deviation); Unit of Measure: Days
	7.4 (3.48)	2.9 (2.24)

4. Secondary Outcome

Title	Death, Kansas City Cardiomyopathy Questionnaire (KCCQ) Score < 45 or KCCQ Score Decrease ≥ 10 Points
Description	Number of patients that had any of these events
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description:	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Overall Number of Participants Analyzed	435	492
Measure Type: Count of Participants; Unit of Measure: Participants
	133	19

5. Secondary Outcome

Title	Death or Stroke
Description	Number of patients that died or had a stroke
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description:	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Overall Number of Participants Analyzed	454	496
Measure Type: Count of Participants; Unit of Measure: Participants
	15	5

6. Secondary Outcome

Title	All Stroke
Description	Number of patients that had a stroke
Time Frame	30 days

Outcome Measure Data

Analysis Population Description

As Treated

Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)	Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description:	SAVR with a commercially available bioprosthetic valve.	TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
Overall Number of Participants Analyzed	454	496
Measure Type: Count of Participants; Unit of Measure: Participants
	11	3

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	Surgical Aortic Valve Replacement (SAVR)		Transcatheter Aortic Valve Replacement (TAVR)
Arm/Group Description	SAVR with a commercially available bioprosthetic valve.		TAVR with the Edwards SAPIEN 3 Transcatheter Heart Valve and Edwards Commander Delivery System
All-Cause Mortality
	Surgical Aortic Valve Replacement (SAVR)		Transcatheter Aortic Valve Replacement (TAVR)
	Affected / at Risk (%)		Affected / at Risk (%)
Total	11/454 (2.42%)		5/496 (1.01%)
Serious Adverse Events
	Surgical Aortic Valve Replacement (SAVR)		Transcatheter Aortic Valve Replacement (TAVR)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	221/454 (48.68%)		153/496 (30.85%)
Blood and lymphatic system disorders
Anaemia † 1	5/454 (1.10%)	5	2/496 (0.40%)	2
Haemolysis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Haemorrhagic anaemia † 1	9/454 (1.98%)	9	3/496 (0.60%)	3
Heparin-induced thrombocytopenia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hypercoagulation † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Leukocytosis † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Thrombocytopenia † 1	5/454 (1.10%)	5	1/496 (0.20%)	1
Cardiac disorders
Acute left ventricular failure † 1	4/454 (0.88%)	4	1/496 (0.20%)	1
Acute myocardial infarction † 1	2/454 (0.44%)	2	1/496 (0.20%)	1
Angina pectoris † 1	4/454 (0.88%)	4	4/496 (0.81%)	4
Arrhythmia † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Arrhythmia supraventricular † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Atrial fibrillation † 1	42/454 (9.25%)	43	11/496 (2.22%)	12
Atrial flutter † 1	12/454 (2.64%)	13	2/496 (0.40%)	2
Atrial tachycardia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Atrioventricular block † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Atrioventricular block complete † 1	15/454 (3.30%)	15	22/496 (4.44%)	23
Atrioventricular block first degree † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Atrioventricular block second degree † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Bradyarrhythmia † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Bradycardia † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Bundle branch block left † 1	1/454 (0.22%)	1	12/496 (2.42%)	12
Cardiac arrest † 1	5/454 (1.10%)	6	4/496 (0.81%)	4
Cardiac failure † 1	4/454 (0.88%)	4	0/496 (0.00%)	0
Cardiac failure acute † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Cardiac failure congestive † 1	7/454 (1.54%)	7	1/496 (0.20%)	1
Cardiac tamponade † 1	3/454 (0.66%)	3	1/496 (0.20%)	1
Cardiogenic shock † 1	6/454 (1.32%)	6	2/496 (0.40%)	2
Cardiomyopathy † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Coronary artery disease † 1	1/454 (0.22%)	1	2/496 (0.40%)	2
Coronary artery occlusion † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Coronary artery stenosis † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Defect conduction intraventricular † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Diastolic dysfunction † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Dressler's syndrome † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Left ventricular enlargement † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Mitral valve incompetence † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Myocardial infarction † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Nodal arrhythmia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Paravalvular aortic regurgitation † 1	2/454 (0.44%)	2	4/496 (0.81%)	4
Pericardial effusion † 1	6/454 (1.32%)	6	2/496 (0.40%)	2
Pericardial haemorrhage † 1	8/454 (1.76%)	8	0/496 (0.00%)	0
Pericarditis constrictive † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Prosthetic cardiac valve thrombosis † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Pulseless electrical activity † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Sinus arrest † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Sinus bradycardia † 1	2/454 (0.44%)	2	1/496 (0.20%)	1
Sinus node dysfunction † 1	2/454 (0.44%)	2	2/496 (0.40%)	2
Sinus tachycardia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Supraventricular tachycardia † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Systolic anterior motion of mitral valve † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Tricuspid valve incompetence † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ventricular extrasystoles † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Ventricular fibrillation † 1	5/454 (1.10%)	5	0/496 (0.00%)	0
Ventricular hypokinesia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ventricular tachycardia † 1	1/454 (0.22%)	1	3/496 (0.60%)	3
Congenital, familial and genetic disorders
Arteriovenous malformation † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Haemorrhagic arteriovenous malformation † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Ventricular septal defect † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ear and labyrinth disorders
Vertigo positional † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Endocrine disorders
Thyroid disorder † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Eye disorders
Amaurosis fugax † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Cataract † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Retinal detachment † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Gastrointestinal disorders
Colitis † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Diarrhoea † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Gastritis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Gastrointestinal haemorrhage † 1	2/454 (0.44%)	2	10/496 (2.02%)	11
Gastrointestinal ulcer haemorrhage † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Gastrointestinal vascular malformation haemorrhagic † 1	1/454 (0.22%)	2	0/496 (0.00%)	0
Haematochezia † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Ileus † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ileus paralytic † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Inguinal hernia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Intestinal ischaemia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Lower gastrointestinal haemorrhage † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Oroantral fistula † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Rectal haemorrhage † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Retroperitoneal haemorrhage † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Small intestinal obstruction † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Umbilical hernia † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Upper gastrointestinal haemorrhage † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
General disorders
Asthenia † 1	3/454 (0.66%)	3	1/496 (0.20%)	1
Chest pain † 1	2/454 (0.44%)	2	1/496 (0.20%)	1
Complication associated with device † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Death † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Gait disturbance † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Localised oedema † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Mass † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Multiple organ dysfunction syndrome † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Non-cardiac chest pain † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Oedema peripheral † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Pyrexia † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Sudden cardiac death † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Systemic inflammatory response syndrome † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hepatobiliary disorders
Bile duct stone † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Biliary dyskinesia † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Cholecystitis † 1	1/454 (0.22%)	2	0/496 (0.00%)	0
Cholelithiasis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ischaemic hepatitis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Immune system disorders
Anaphylactic reaction † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Infections and infestations
Alpha haemolytic streptococcal infection † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Arthritis infective † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Bacteraemia † 1	0/454 (0.00%)	0	3/496 (0.60%)	3
Biliary sepsis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Bronchitis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Cellulitis † 1	0/454 (0.00%)	0	3/496 (0.60%)	3
Cholecystitis infective † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Chronic sinusitis † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Diverticulitis † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Endocarditis † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Endocarditis enterococcal † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Escherichia urinary tract infection † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Influenza † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Pneumonia † 1	5/454 (1.10%)	5	3/496 (0.60%)	3
Pneumonia streptococcal † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Post procedural infection † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Postoperative wound infection † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Respiratory tract infection † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Sepsis † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Septic shock † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Serratia sepsis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Streptococcal infection † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Urinary tract infection † 1	3/454 (0.66%)	3	1/496 (0.20%)	1
Vascular access site infection † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Injury, poisoning and procedural complications
Anaemia postoperative † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Ankle fracture † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Arterial injury † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Cardiac valve replacement complication † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Fall † 1	0/454 (0.00%)	0	3/496 (0.60%)	3
Hip fracture † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Humerus fracture † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Incision site haemorrhage † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Incisional hernia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Post procedural haemorrhage † 1	4/454 (0.88%)	4	0/496 (0.00%)	0
Post procedural myocardial infarction † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Postoperative delirium † 1	2/454 (0.44%)	2	1/496 (0.20%)	1
Postoperative ileus † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Procedural haemorrhage † 1	13/454 (2.86%)	14	0/496 (0.00%)	0
Procedural hypotension † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Procedural pneumothorax † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Subdural haematoma † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Tibia fracture † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Transfusion reaction † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Vascular access site bruising † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Vascular access site complication † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Vascular access site haematoma † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Vascular access site pseudoaneurysm † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Vascular pseudoaneurysm † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Vasoplegia syndrome † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Venous injury † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Investigations
Anticoagulation drug level below therapeutic † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Blood pressure systolic increased † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Cardiac murmur † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Ejection fraction decreased † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
International normalised ratio increased † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Pulmonary arterial pressure increased † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Troponin increased † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
White blood cell count increased † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Metabolism and nutrition disorders
Dehydration † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Electrolyte imbalance † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Fluid overload † 1	2/454 (0.44%)	3	1/496 (0.20%)	1
Gout † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hyperkalaemia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hypervolaemia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hyponatraemia † 1	1/454 (0.22%)	1	2/496 (0.40%)	2
Musculoskeletal and connective tissue disorders
Arthralgia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Arthritis † 1	1/454 (0.22%)	1	2/496 (0.40%)	2
Back pain † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Fracture nonunion † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Groin pain † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Intervertebral disc protrusion † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Lumbar spinal stenosis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Muscular weakness † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Musculoskeletal pain † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Osteoarthritis † 1	0/454 (0.00%)	0	5/496 (1.01%)	5
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Bone cancer metastatic † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Gastrointestinal stromal tumour † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Lung cancer metastatic † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Malignant melanoma † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Myelodysplastic syndrome † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Neoplasm malignant † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Non-small cell lung cancer † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Prostate cancer † 1	0/454 (0.00%)	0	3/496 (0.60%)	3
Rectal cancer † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Squamous cell carcinoma of skin † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Thyroid cancer † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Nervous system disorders
Ataxia † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Cerebral haemorrhage † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Cerebral infarction † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Cerebrovascular accident † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Embolic stroke † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Encephalopathy † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Facial paralysis † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Generalised tonic-clonic seizure † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Haemorrhage intracranial † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Haemorrhagic stroke † 1	2/454 (0.44%)	2	1/496 (0.20%)	1
Hypoaesthesia † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ischaemic stroke † 1	7/454 (1.54%)	7	4/496 (0.81%)	4
Lacunar infarction † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Metabolic encephalopathy † 1	2/454 (0.44%)	2	1/496 (0.20%)	1
Nerve compression † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Presyncope † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Sciatica † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Syncope † 1	4/454 (0.88%)	4	2/496 (0.40%)	2
Toxic encephalopathy † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Transient ischaemic attack † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Product Issues
Device breakage † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Lead dislodgement † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Psychiatric disorders
Alcohol withdrawal syndrome † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Confusional state † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Depression † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hallucination, visual † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	7/454 (1.54%)	7	3/496 (0.60%)	3
Haematuria † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Nephrolithiasis † 1	1/454 (0.22%)	3	1/496 (0.20%)	1
Renal failure † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Renal injury † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Renal mass † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Renal tubular necrosis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Ureterolithiasis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Urinary retention † 1	3/454 (0.66%)	3	2/496 (0.40%)	2
Reproductive system and breast disorders
Benign prostatic hyperplasia † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Scrotal haematocoele † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Respiratory, thoracic and mediastinal disorders
Acquired diaphragmatic eventration † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Acute respiratory distress syndrome † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Acute respiratory failure † 1	4/454 (0.88%)	4	1/496 (0.20%)	1
Asthma † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Atelectasis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Bronchial hyperreactivity † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Chronic obstructive pulmonary disease † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Dyspnoea † 1	5/454 (1.10%)	5	3/496 (0.60%)	4
Dyspnoea exertional † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Epistaxis † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Haemothorax † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Hypoxia † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Mediastinal haematoma † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Mediastinal haemorrhage † 1	3/454 (0.66%)	3	0/496 (0.00%)	0
Pharyngeal haemorrhage † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Pleural effusion † 1	18/454 (3.96%)	20	1/496 (0.20%)	1
Pneumothorax † 1	7/454 (1.54%)	7	0/496 (0.00%)	0
Pulmonary embolism † 1	2/454 (0.44%)	2	2/496 (0.40%)	2
Pulmonary sarcoidosis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Respiratory acidosis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Respiratory failure † 1	6/454 (1.32%)	6	1/496 (0.20%)	1
Skin and subcutaneous tissue disorders
Eczema † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Surgical and medical procedures
Appendicectomy † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Cardiac pacemaker replacement † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hip arthroplasty † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Knee arthroplasty † 1	1/454 (0.22%)	1	2/496 (0.40%)	2
Knee operation † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Percutaneous coronary intervention † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Pericardial excision † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Stent placement † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Vascular disorders
Aortic dissection † 1	0/454 (0.00%)	0	2/496 (0.40%)	2
Aortic rupture † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Arterial haemorrhage † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
Deep vein thrombosis † 1	3/454 (0.66%)	3	1/496 (0.20%)	1
Femoral artery dissection † 1	0/454 (0.00%)	0	3/496 (0.60%)	3
Femoral artery perforation † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Haematoma † 1	4/454 (0.88%)	4	2/496 (0.40%)	2
Haemorrhage † 1	2/454 (0.44%)	2	0/496 (0.00%)	0
Hypertension † 1	1/454 (0.22%)	1	2/496 (0.40%)	2
Hypertensive crisis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Hypotension † 1	6/454 (1.32%)	6	1/496 (0.20%)	1
Peripheral artery stenosis † 1	0/454 (0.00%)	0	3/496 (0.60%)	3
Peripheral embolism † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Peripheral ischaemia † 1	1/454 (0.22%)	1	2/496 (0.40%)	2
Renovascular hypertension † 1	0/454 (0.00%)	0	1/496 (0.20%)	1
Temporal arteritis † 1	1/454 (0.22%)	1	0/496 (0.00%)	0
Vessel perforation † 1	1/454 (0.22%)	1	1/496 (0.20%)	1
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Surgical Aortic Valve Replacement (SAVR)		Transcatheter Aortic Valve Replacement (TAVR)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	305/454 (67.18%)		133/496 (26.81%)
Blood and lymphatic system disorders
Anaemia † 1	28/454 (6.17%)	29	0/496 (0.00%)	0
Haemorrhagic anaemia † 1	59/454 (13.00%)	60	0/496 (0.00%)	0
Thrombocytopenia † 1	24/454 (5.29%)	24	0/496 (0.00%)	0
Cardiac disorders
Atrial fibrillation † 1	145/454 (31.94%)	154	36/496 (7.26%)	38
Atrioventricular block first degree † 1	26/454 (5.73%)	26	26/496 (5.24%)	26
Bundle branch block left † 1	37/454 (8.15%)	37	92/496 (18.55%)	93
Bundle branch block right † 1	28/454 (6.17%)	28	0/496 (0.00%)	0
Injury, poisoning and procedural complications
Procedural haemorrhage † 1	88/454 (19.38%)	89	0/496 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	40/454 (8.81%)	41	0/496 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pleural effusion † 1	39/454 (8.59%)	40	0/496 (0.00%)	0
1 Term from vocabulary, MedDRA (Unspecified); † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Research Director
• Organization: Edwards Lifesciences
• Phone: 949-250-2500
• EMail: THV_CT.gov@Edwards.com

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Genereux P, Pibarot P, Redfors B, Bax JJ, Zhao Y, Makkar RR, Kapadia S, Thourani VH, Mack MJ, Nazif TM, Lindman BR, Babaliaros V, Vincent F, Russo M, McCabe JM, Gillam LD, Alu MC, Hahn RT, Webb JG, Leon MB, Cohen DJ. Evolution and Prognostic Impact of Cardiac Damage After Aortic Valve Replacement. J Am Coll Cardiol. 2022 Aug 23;80(8):783-800. doi: 10.1016/j.jacc.2022.05.006. Epub 2022 May 17.

Ternacle J, Al-Azizi K, Szerlip M, Potluri S, Hamandi M, Blanke P, Leipsic J, Dahou A, Salaun E, Vincent F, Rogers E, Alu MC, Lu M, Yu X, Thourani VH, Hahn RT, Leon MB, Pibarot P, Mack MJ. Impact of Predilation During Transcatheter Aortic Valve Replacement: Insights From the PARTNER 3 Trial. Circ Cardiovasc Interv. 2021 Jul;14(7):e010336. doi: 10.1161/CIRCINTERVENTIONS.120.010336. Epub 2021 Jun 18.

Herrmann HC, Cohen DJ, Hahn RT, Babaliaros VC, Yu X, Makkar R, McCabe J, Szerlip M, Kapadia S, Russo M, Malaisrie SC, Webb JG, Szeto WY, Kodali S, Thourani VH, Mack MJ, Leon MB. Utilization, Costs, and Outcomes of Conscious Sedation Versus General Anesthesia for Transcatheter Aortic Valve Replacement. Circ Cardiovasc Interv. 2021 Jul;14(7):e010310. doi: 10.1161/CIRCINTERVENTIONS.120.010310. Epub 2021 Jun 16.

Leon MB, Mack MJ, Hahn RT, Thourani VH, Makkar R, Kodali SK, Alu MC, Madhavan MV, Chau KH, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Blanke P, Leipsic JA, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Herrmann HC, Szeto WY, Genereux P, Pershad A, Lu M, Webb JG, Smith CR, Pibarot P; PARTNER 3 Investigators. Outcomes 2 Years After Transcatheter Aortic Valve Replacement in Patients at Low Surgical Risk. J Am Coll Cardiol. 2021 Mar 9;77(9):1149-1161. doi: 10.1016/j.jacc.2020.12.052.

Pibarot P, Salaun E, Dahou A, Avenatti E, Guzzetti E, Annabi MS, Toubal O, Bernier M, Beaudoin J, Ong G, Ternacle J, Krapf L, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Leipsic J, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Alu MC, Xu K, Rogers E, Webb JG, Smith CR, Mack MJ, Leon MB, Hahn RT; PARTNER 3 Investigators. Echocardiographic Results of Transcatheter Versus Surgical Aortic Valve Replacement in Low-Risk Patients: The PARTNER 3 Trial. Circulation. 2020 May 12;141(19):1527-1537. doi: 10.1161/CIRCULATIONAHA.119.044574. Epub 2020 Apr 10.

Mack MJ, Leon MB, Thourani VH, Makkar R, Kodali SK, Russo M, Kapadia SR, Malaisrie SC, Cohen DJ, Pibarot P, Leipsic J, Hahn RT, Blanke P, Williams MR, McCabe JM, Brown DL, Babaliaros V, Goldman S, Szeto WY, Genereux P, Pershad A, Pocock SJ, Alu MC, Webb JG, Smith CR; PARTNER 3 Investigators. Transcatheter Aortic-Valve Replacement with a Balloon-Expandable Valve in Low-Risk Patients. N Engl J Med. 2019 May 2;380(18):1695-1705. doi: 10.1056/NEJMoa1814052. Epub 2019 Mar 16.

Leipsic J, Bax JJ, Webb JG, Martin R, Blanke P. Trials Testing the Value of Imaging Use in Valve Disease and in Transcatheter Valvular Interventions. JACC Cardiovasc Imaging. 2017 Mar;10(3):286-295. doi: 10.1016/j.jcmg.2016.09.031.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT02675114
• Other Study ID Numbers: 2015-08
• First Submitted: January 22, 2016
• First Posted: February 5, 2016
• Results First Submitted: October 7, 2021
• Results First Posted: December 2, 2021
• Last Update Posted: November 30, 2023