PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - S3 Intermediate (PII S3i)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

ClinicalTrials.gov Identifier: NCT03222128

Recruitment Status : Active, not recruiting

First Posted : July 19, 2017

Results First Posted : August 14, 2018

Last Update Posted : November 30, 2023

View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Edwards Lifesciences

Study Type	Interventional
Study Design	Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Symptomatic Severe Aortic Stenosis
Intervention	Device: TAVR
Enrollment	1074

Participant Flow

Recruitment Details	Subjects were screened and enrolled at 51 sites in the US
Pre-assignment Details	The As-Treated population was 1074 The Valve-Implanted population was 1069


Arm/Group Title	PIIS3i - SAPIEN 3
Arm/Group Description	PIIS3i - SAPIEN 3 is Operable Group...
Arm/Group Description	PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3
Period Title: Overall Study
Started	1074
Valve-Implanted	1069
Completed ^[1]	968
Not Completed	106
[1] One year follow-up

Baseline Characteristics

Arm/Group Title		PIIS3i - SAPIEN 3
Arm/Group Description		PIIS3i - SAPIEN 3 is Operable Group...
Arm/Group Description		PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3
Overall Number of Baseline Participants		1074
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	1074 participants
		81.9 (6.6)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1074 participants
	Female	412 38.4%
	Male	662 61.6%
STS Score ^[1] Mean (Standard Deviation) Unit of measure: Units on a scale
	Number Analyzed	1074 participants
		5.3 (1.29)
		[1] Measure Description: The Society of Thoracic Surgeons (STS) Score measures patient risk of mortality or morbidity at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
NYHA Classification III/IV ^[1] Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	1074 participants
		780 72.6%
		[1] Measure Description: 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-V, with the lowest as no limitations and highest unable to carry on any physical activity without discomfort.

Outcome Measures

1.Primary Outcome


Title	Number of Participants With Composite of All-cause Death, All Stroke and Aortic Insufficiency (AI) ≥ Moderate
Description	[Not Specified]
Description	[Not Specified]
Time Frame	1 year

Outcome Measure Data

Analysis Population Description

AI as a factor in this value; only 964/1069 patients had ECHO data.


Arm/Group Title	PIIS3i - SAPIEN 3
Arm/Group Description:	PIIS3i - SAPIEN 3 is Operable Group...
Arm/Group Description:	PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3
Overall Number of Participants Analyzed	964
Measure Type: Count of Participants Unit of Measure: Participants
	125 13.0%

2.Secondary Outcome


Title	Composite of All-cause Death, All Stroke, Life Threatening (Disabling)/ Major Bleeding and Major Vascular Complication at 30 Days
Description	[Not Specified]
Description	[Not Specified]
Time Frame	30 Days

Outcome Measure Data

Analysis Population Description

[Not Specified]


Arm/Group Title	PIIS3i - SAPIEN 3
Arm/Group Description:	PIIS3i - SAPIEN 3 is Operable Group...
Arm/Group Description:	PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3
Overall Number of Participants Analyzed	1069
Measure Type: Count of Participants Unit of Measure: Participants
	196 18.3%

Adverse Events

Time Frame	The Adverse data collected and reported here are over a period of 1 Year Valve-implant population are noted here.
Adverse Event Reporting Description	All Adverse Events are site-reported.

Arm/Group Title	PIIS3i - SAPIEN 3
Arm/Group Description	PIIS3i - SAPIEN 3 is Operable Group...
Arm/Group Description	PIIS3i - SAPIEN 3 is Operable Group TAVR: Implantation of the SAPIEN 3
All-Cause Mortality
	PIIS3i - SAPIEN 3
	Affected / at Risk (%)
Total	75/1069 (7.02%)
Serious Adverse Events Serious Adverse Events
	PIIS3i - SAPIEN 3
	Affected / at Risk (%)	# Events
Total	592/1069 (55.38%)
Blood and lymphatic system disorders
Anemia/Hemolytic anemia ^† 1	25/1069 (2.34%)	29
Thrombocytopenia ^† 1	14/1069 (1.31%)	15
Cardiac disorders
Angina/Cardiac chest pain ^† 1	16/1069 (1.50%)	17
Aortic Valve Stenosis ^† 1	2/1069 (0.19%)	2
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction ^† 1	7/1069 (0.65%)	7
Arrhythmia/Conduction system injury (defect) ^† 1	195/1069 (18.24%)	216
Cardiac arrest ^† 1	17/1069 (1.59%)	17
Cardiac tamponade/Pericardial effusion ^† 1	14/1069 (1.31%)	14
Cardiogenic shock ^† 1	2/1069 (0.19%)	3
Coronary artery disease/Coronary ischemia ^† 1	8/1069 (0.75%)	11
Coronary flow obstruction/Transvalvular flow disturbance ^† 1	1/1069 (0.09%)	1
Heart failure/CHF/Low output failure ^† 1	76/1069 (7.11%)	96
Myocardial Infarction ^† 1	13/1069 (1.22%)	15
Mitral valve injury or insufficiency ^† 1	3/1069 (0.28%)	3
Pericarditis ^† 1	1/1069 (0.09%)	1
Ear and labyrinth disorders
Edema ^† 1	1/1069 (0.09%)	1
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic ^† 1	31/1069 (2.90%)	33
General disorders
Aortic insufficiency/Regurgitation PV leak - Structural dysfunction ^† 1	1/1069 (0.09%)	1
Aortic insufficiency/Regurgitation non valvular cause ^† 1	1/1069 (0.09%)	1
Hemolysis ^† 1	1/1069 (0.09%)	1
Miscellaneous - Other ^† 1	15/1069 (1.40%)	15
Multi organ failure ^† 1	1/1069 (0.09%)	1
Unknown cause of death ^† 1	5/1069 (0.47%)	5
Other ^† 1	38/1069 (3.55%)	41
Infections and infestations
Infection - Access site infection ^† 1	4/1069 (0.37%)	4
Infection - Bacteremia ^† 1	5/1069 (0.47%)	5
Infection - Endocarditis ^† 1	8/1069 (0.75%)	8
Infection - Other ^† 1	26/1069 (2.43%)	27
Infection - Respiratory infection ^† 1	55/1069 (5.14%)	63
Infection - Sepsis ^† 1	28/1069 (2.62%)	29
Infection - Urinary tract infection ^† 1	20/1069 (1.87%)	21
Injury, poisoning and procedural complications
Access site and access related vascular injury - Failure of percutaneous access site closure ^† 1 [1]	8/1069 (0.75%)	8
Anesthesia related complication - Confusion ^† 1	1/1069 (0.09%)	1
Anesthesia related complication - Other ^† 1	1/1069 (0.09%)	1
Bleeding - Hemorrhage ^† 1	111/1069 (10.38%)	134
Device migration/malposition requiring intervention ^† 1	3/1069 (0.28%)	3
Miscellaneous - Fall ^† 1	23/1069 (2.15%)	25
Musculoskeletal - Fracture ^† 1	33/1069 (3.09%)	36
Investigations
Ischemia ^† 1	8/1069 (0.75%)	10
Mental state change (not neurological) - Confusion ^† 1	5/1069 (0.47%)	5
Mental state change (not neurological) - Dementia ^† 1	2/1069 (0.19%)	2
Mental state change (not neurological) - Depression ^† 1	2/1069 (0.19%)	2
Miscellaneous - Drug reaction ^† 1	2/1069 (0.19%)	2
Metabolism and nutrition disorders
Abnormal lab value ^† 1	22/1069 (2.06%)	26
Exercise intolerance or weakness ^† 1	2/1069 (0.19%)	2
Musculoskeletal and connective tissue disorders
Musculoskeletal - Pain ^† 1	25/1069 (2.34%)	25
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Miscellaneous - Cancer ^† 1	17/1069 (1.59%)	17
Nervous system disorders
Carotid artery disease ^† 1	5/1069 (0.47%)	5
Encephalopathy ^† 1	3/1069 (0.28%)	3
Neurological - Change in level of consciousness ^† 1	1/1069 (0.09%)	1
Neurological - Cognitive impairment ^† 1	2/1069 (0.19%)	2
Neurological - Dysphasia/Aphasia ^† 1	1/1069 (0.09%)	1
Neurological - Hemiparesis (One sided body weakness) ^† 1	1/1069 (0.09%)	1
Neurological - Hemorrhagic stroke ^† 1	8/1069 (0.75%)	8
Neurological - Ischemic stroke ^† 1	24/1069 (2.25%)	25
Neurological - Other ^† 1	6/1069 (0.56%)	7
Neurological - Other new neurological sign consistent with stroke ^† 1	1/1069 (0.09%)	1
Neurological - TIA ^† 1	10/1069 (0.94%)	12
Neurological - Undetermined stroke ^† 1	7/1069 (0.65%)	8
Psychiatric disorders
Delirium ^† 1	3/1069 (0.28%)	3
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic ^† 1	17/1069 (1.59%)	17
Renal insufficiency or renal failure ^† 1	31/1069 (2.90%)	34
Respiratory, thoracic and mediastinal disorders
Respiratory event - Aspiration ^† 1	2/1069 (0.19%)	3
Respiratory event - Atelectasis ^† 1	1/1069 (0.09%)	1
Respiratory event - Dyspnea ^† 1	15/1069 (1.40%)	15
Respiratory event - Other ^† 1	17/1069 (1.59%)	18
Respiratory event - Pneumothorax ^† 1	2/1069 (0.19%)	2
Respiratory event - Pulmonary edema ^† 1	2/1069 (0.19%)	2
Respiratory event - Pulmonary effusion ^† 1	17/1069 (1.59%)	17
Respiratory event - Respiratory failure ^† 1	32/1069 (2.99%)	37
Social circumstances
Miscellaneous - Suicide ^† 1	1/1069 (0.09%)	1
Vascular disorders
Access site and access related vascular injury - Dissection ^† 1	11/1069 (1.03%)	11
Access site and access related vascular injury - Distal embolization (noncerebral) from vascular sou ^† 1	1/1069 (0.09%)	1
Access site and access related vascular injury - Hematoma ^† 1	5/1069 (0.47%)	5
Access site and access related vascular injury - Other ^† 1	8/1069 (0.75%)	8
Access site and access related vascular injury - Perforation ^† 1	4/1069 (0.37%)	4
Access site and access related vascular injury - Pseudoaneurysm ^† 1	4/1069 (0.37%)	4
Access site and access related vascular injury - Rupture ^† 1	1/1069 (0.09%)	1
Access site and access related vascular injury - Stenosis ^† 1	5/1069 (0.47%)	5
Access site and access related vascular injury - Ventricular rupture (Apical rupture) ^† 1	2/1069 (0.19%)	2
Hypertension ^† 1	10/1069 (0.94%)	10
Hypotension ^† 1	11/1069 (1.03%)	11
Syncope ^† 1	14/1069 (1.31%)	15
Thromboembolic event ^† 1	13/1069 (1.22%)	13
Valve thrombosis ^† 1	1/1069 (0.09%)	1
Vascular complication - Non-access related ^† 1	16/1069 (1.50%)	18
1 Term from vocabulary, MedDRA (10.0) † Indicates events were collected by systematic assessment [1] resulting in intervention
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	PIIS3i - SAPIEN 3
	Affected / at Risk (%)	# Events
Total	861/1069 (80.54%)
Blood and lymphatic system disorders
Anemia/Hemolytic anemia ^† 1	128/1069 (11.97%)	140
Thrombocytopenia ^† 1	101/1069 (9.45%)	101
Cardiac disorders
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction ^† 1	55/1069 (5.14%)	55
Arrhythmia/Conduction system injury (defect) ^† 1	299/1069 (27.97%)	357
Heart failure/CHF/Low output failure ^† 1	95/1069 (8.89%)	101
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic ^† 1	66/1069 (6.17%)	77
Infections and infestations
Infection - Other ^† 1	55/1069 (5.14%)	62
Infection - Urinary tract infection ^† 1	87/1069 (8.14%)	101
Injury, poisoning and procedural complications
Miscellaneous - Fall ^† 1	70/1069 (6.55%)	81
Investigations
Abnormal lab value ^† 1	144/1069 (13.47%)	186
Miscellaneous - Other ^† 1	65/1069 (6.08%)	72
Other ^† 1	111/1069 (10.38%)	136
Musculoskeletal and connective tissue disorders
Musculoskeletal - Pain ^† 1	81/1069 (7.58%)	94
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic ^† 1	83/1069 (7.76%)	88
Renal insufficiency or renal failure ^† 1	117/1069 (10.94%)	134
Respiratory, thoracic and mediastinal disorders
Respiratory event - Pulmonary effusion ^† 1	63/1069 (5.89%)	67
Vascular disorders
Bleeding - Hemorrhage ^† 1	212/1069 (19.83%)	240
Hypertension ^† 1	57/1069 (5.33%)	59
Hypotension ^† 1	63/1069 (5.89%)	68
1 Term from vocabulary, MedDRA (10.0) † 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 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

Layout table for Results Point of Contact information

Name/Title:	Director of Research
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):

Vincent F, Thourani VH, Ternacle J, Redfors B, Cohen DJ, Hahn RT, Li D, Crowley A, Webb JG, Mack MJ, Kapadia S, Russo M, Smith CR, Alu MC, Leon MB, Pibarot P. Time-of-Day and Clinical Outcomes After Surgical or Transcatheter Aortic Valve Replacement: Insights From the PARTNER Trials. Circ Cardiovasc Qual Outcomes. 2022 Jan;15(1):e007948. doi: 10.1161/CIRCOUTCOMES.121.007948. Epub 2022 Jan 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.

Brener MI, George I, Kosmidou I, Nazif T, Zhang Z, Dizon JM, Garan H, Malaisrie SC, Makkar R, Mack M, Szeto WY, Fearon WF, Thourani VH, Leon MB, Kodali S, Biviano AB. Atrial Fibrillation Is Associated With Mortality in Intermediate Surgical Risk Patients With Severe Aortic Stenosis: Analyses From the PARTNER 2A and PARTNER S3i Trials. J Am Heart Assoc. 2021 Apr 6;10(7):e019584. doi: 10.1161/JAHA.120.019584. Epub 2021 Mar 23.

Ong G, Pibarot P, Redfors B, Weissman NJ, Jaber WA, Makkar RR, Lerakis S, Gopal D, Khalique O, Kodali SK, Thourani VH, Anwaruddin S, McAndrew T, Zhang Y, Alu MC, Douglas PS, Hahn RT. Diastolic Function and Clinical Outcomes After Transcatheter Aortic Valve Replacement: PARTNER 2 SAPIEN 3 Registry. J Am Coll Cardiol. 2020 Dec 22;76(25):2940-2951. doi: 10.1016/j.jacc.2020.10.032.

Pibarot P, Ternacle J, Jaber WA, Salaun E, Dahou A, Asch FM, Weissman NJ, Rodriguez L, Xu K, Annabi MS, Guzzetti E, Beaudoin J, Bernier M, Leipsic J, Blanke P, Clavel MA, Rogers E, Alu MC, Douglas PS, Makkar R, Miller DC, Kapadia SR, Mack MJ, Webb JG, Kodali SK, Smith CR, Herrmann HC, Thourani VH, Leon MB, Hahn RT; PARTNER 2 Investigators. Structural Deterioration of Transcatheter Versus Surgical Aortic Valve Bioprostheses in the PARTNER-2 Trial. J Am Coll Cardiol. 2020 Oct 20;76(16):1830-1843. doi: 10.1016/j.jacc.2020.08.049.

Chen S, Redfors B, O'Neill BP, Clavel MA, Pibarot P, Elmariah S, Nazif T, Crowley A, Ben-Yehuda O, Finn MT, Alu MC, Vahl TP, Kodali S, Leon MB, Lindman BR. Low and elevated B-type natriuretic peptide levels are associated with increased mortality in patients with preserved ejection fraction undergoing transcatheter aortic valve replacement: an analysis of the PARTNER II trial and registry. Eur Heart J. 2020 Feb 21;41(8):958-969. doi: 10.1093/eurheartj/ehz892.

Summers MR, Leon MB, Smith CR, Kodali SK, Thourani VH, Herrmann HC, Makkar RR, Pibarot P, Webb JG, Leipsic J, Alu MC, Crowley A, Hahn RT, Kapadia SR, Tuzcu EM, Svensson L, Cremer PC, Jaber WA. Prosthetic Valve Endocarditis After TAVR and SAVR: Insights From the PARTNER Trials. Circulation. 2019 Dec 10;140(24):1984-1994. doi: 10.1161/CIRCULATIONAHA.119.041399. Epub 2019 Nov 6.

Furer A, Chen S, Redfors B, Elmariah S, Pibarot P, Herrmann HC, Hahn RT, Kodali S, Thourani VH, Douglas PS, Alu MC, Fearon WF, Passeri J, Malaisrie SC, Crowley A, McAndrew T, Genereux P, Ben-Yehuda O, Leon MB, Burkhoff D. Effect of Baseline Left Ventricular Ejection Fraction on 2-Year Outcomes After Transcatheter Aortic Valve Replacement: Analysis of the PARTNER 2 Trials. Circ Heart Fail. 2019 Aug;12(8):e005809. doi: 10.1161/CIRCHEARTFAILURE.118.005809. Epub 2019 Aug 1.

Nazif TM, Chen S, George I, Dizon JM, Hahn RT, Crowley A, Alu MC, Babaliaros V, Thourani VH, Herrmann HC, Smalling RW, Brown DL, Mack MJ, Kapadia S, Makkar R, Webb JG, Leon MB, Kodali SK. New-onset left bundle branch block after transcatheter aortic valve replacement is associated with adverse long-term clinical outcomes in intermediate-risk patients: an analysis from the PARTNER II trial. Eur Heart J. 2019 Jul 14;40(27):2218-2227. doi: 10.1093/eurheartj/ehz227.

Layout table for additonal information

Responsible Party:	Edwards Lifesciences
ClinicalTrials.gov Identifier:	NCT03222128
Other Study ID Numbers:	2010-12 PIIS3i
First Submitted:	July 17, 2017
First Posted:	July 19, 2017
Results First Submitted:	December 7, 2017
Results First Posted:	August 14, 2018
Last Update Posted:	November 30, 2023

To Top