PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (PII A)

• ClinicalTrials.gov Identifier: NCT01314313
• Recruitment Status: Completed
• First Posted: March 14, 2011
• Results First Posted: August 14, 2018
• Last Update Posted: March 7, 2024
• 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: Symptomatic Severe Aortic Stenosis
• Interventions: Device: TAVR Implantation with SAPIEN XT; Device: SAVR Implantation
• Enrollment: 2032

Participant Flow

Recruitment Details	Between December 23, 2011 to November 6, 2013 2,032 patients were enrolled into the PARTNER II A SAPIEN XT vs SAVR Intermediate Risk Trial at 57 sites in the United States and Canada.
Pre-assignment Details

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description	Edwards SAPIEN XT Transcatheter Heart Valve (THV) NOTE: SAVR with surgical bioprosthetic heart valve is the control arm.	Surgical Aortic Valve Replacement (SAVR)
Period Title: Overall Study
Started	1011	1021
As Treated	994	944
Valve Implanted	974	936
Completed [1]	784	710
Not Completed	227	311
[1] This is two year follow-up

Baseline Characteristics

Arm/Group Title		PIIA: SAPIEN XT	Control: SAVR	Total
Arm/Group Description		Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Surgical Aortic Valve Replacement (SAVR); Control for PIIA: SAPIEN XT	Total of all reporting groups
Overall Number of Baseline Participants		1011	1021	2032
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	1011 participants	1021 participants	2032 participants
		81.5 (6.70)	81.7 (6.71)	81.6 (6.70)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	1011 participants	1021 participants	2032 participants
	Female	463 45.8%	461 45.2%	924 45.5%
	Male	548 54.2%	560 54.8%	1108 54.5%
STS Score [1]; Mean (Standard Deviation); Unit of measure: % risk of mortality or morbidity
	Number Analyzed	1011 participants	1021 participants	2032 participants
		5.8 (2.08)	5.8 (1.87)	5.8 (1.98)
		[1] Measure Description: The Society of Thoracic Surgeons (STS) score measures patient risk at the time of cardiovascular surgery on a scale that ranges from 0% to 100%, with higher numbers indicating greater risk.
NYHA Classification [1]; Measure Type: Number; Unit of measure: Participants	Number Analyzed	1011 participants	1021 participants	2032 participants
NYHA I/II		229	244	473
NYHA III/VI		782	776	1558
		[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 - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.

Outcome Measures

1. Primary Outcome

Title	All-cause Death or Disabling Stroke to Two Years
Description	All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)
Time Frame	2 Years

Outcome Measure Data

Analysis Population Description

Participants include all patients who were randomized.

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description:	Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed	1011	1021
Measure Type: Count of Participants; Unit of Measure: Participants
	192 19.0%	202 19.8%

2. Secondary Outcome

Title	Adjusted Days Alive and Out of Hospital (DAOH) to Two Years
Description	The number of days the patients are alive and out of the hospital.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Intent to Treat Population: All randomized patients with the exception of Total Aortic Regurgitation and Effective Orifice Area which was analyzed with the Valve Implant Population: All randomized patients receiving the valve.

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description:	Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed	998	953
Mean (Standard Deviation); Unit of Measure: days
	629.4 (208.54)	597.8 (236.80)

3. Secondary Outcome

Title	Total Aortic Regurgitation (AR) at 2 Years
Description	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 two year was analyzed in the valve implant population.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

All randomized patients who received the valve were analyzed. Note: Echos were not available for all the patients who made the follow-up visit.

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description:	Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed	606	520
Mean (Standard Deviation); Unit of Measure: Grade
	1.2 (1.0)	0.5 (0.7)

4. Secondary Outcome

Title	6MWT Change From Baseline
Description	Six Minute Walk Test change from baseline to 2 years
Time Frame	Baseline and 2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description:	Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed	604	1021
Mean (Standard Deviation); Unit of Measure: meters
	14.5 (128.7)	NA [1] (NA)

[1]

This secondary endpoint analyzes change within the SAPIEN XT Cohort.

5. Secondary Outcome

Title	NYHA Classification at 2 Years
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 - IV, with the lowest as no limitations and the highest unable to carry on any physical activity without discomfort.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description:	Intermediate Risk Surgical Patients: Transcatheter Heart Valve (THV)	Control: Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed	737	649
Mean (Standard Deviation); Unit of Measure: units on a scale
	1.5 (0.7)	1.4 (0.6)

6. Secondary Outcome

Title	Effective Orifice Area (EOA)
Description	[Not Specified]
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Effective Orifice Area is listed for only the patients who had echo available at the follow-up visit.

Arm/Group Title	PIIA: SAPIEN XT	Control: SAVR
Arm/Group Description:	Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Surgical Aortic Valve Replacement (SAVR)
Overall Number of Participants Analyzed	573	490
Mean (Standard Deviation); Unit of Measure: cm^2
	1.5 (0.4)	1.4 (0.4)

Adverse Events

Time Frame	Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock.
Adverse Event Reporting Description	Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Arm/Group Title	PIIA: SAPIEN XT - 2 Year		Control: SAVR - 2 Year
Arm/Group Description	Edwards SAPIEN XT Transcatheter Heart Valve (THV)		Surgical Aortic Valve Replacement (SAVR) NOTE: SAVR with surgical bioprosthetic heart valve is the control arm.
All-Cause Mortality
	PIIA: SAPIEN XT - 2 Year		Control: SAVR - 2 Year
	Affected / at Risk (%)		Affected / at Risk (%)
Total	166/1011 (16.42%)		170/1021 (16.65%)
Serious Adverse Events
	PIIA: SAPIEN XT - 2 Year		Control: SAVR - 2 Year
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	666/974 (68.38%)		672/936 (71.79%)
Blood and lymphatic system disorders
Anemia/Hemolytic anemia † 1	24/974 (2.46%)	26	38/936 (4.06%)	43
Thrombocytopenia † 1	8/974 (0.82%)	8	24/936 (2.56%)	24
Cardiac disorders
Angina/Cardiac chest pain † 1	22/974 (2.26%)	28	24/936 (2.56%)	30
Arrhythmia/Conduction system injury (defect) † 1	170/974 (17.45%)	186	196/936 (20.94%)	226
Cardiac arrest † 1	33/974 (3.39%)	33	36/936 (3.85%)	38
Cardiac tamponade/Pericardial effusion † 1	21/974 (2.16%)	21	13/936 (1.39%)	13
Cardiogenic shock † 1	9/974 (0.92%)	9	20/936 (2.14%)	20
Heart failure/CHF/Low output failure † 1	127/974 (13.04%)	197	103/936 (11.00%)	134
MI † 1	29/974 (2.98%)	29	26/936 (2.78%)	30
Mitral valve injury or insufficiency † 1	1/974 (0.10%)	1	2/936 (0.21%)	2
Pericarditis † 1	0/974 (0.00%)	0	2/936 (0.21%)	2
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic † 1	67/974 (6.88%)	77	53/936 (5.66%)	65
General disorders
Aortic insufficiency/Regurgitation PV leak - Non structural dysfunction † 1	24/974 (2.46%)	30	8/936 (0.85%)	9
Aortic insufficiency/Regurgitation PV leak - Structural dysfunction † 1	7/974 (0.72%)	7	1/936 (0.11%)	1
Aortic insufficiency/Regurgitation non valvular cause † 1	2/974 (0.21%)	3	0/936 (0.00%)	0
Coronary flow obstruction/Transvalvular flow disturbance † 1	6/974 (0.62%)	9	8/936 (0.85%)	8
Device embolization † 1	6/974 (0.62%)	6	0/936 (0.00%)	0
Device migration/malposition requiring intervention † 1	6/974 (0.62%)	6	0/936 (0.00%)	0
Edema † 1	7/974 (0.72%)	7	7/936 (0.75%)	7
Exercise intolerance or weakness † 1	2/974 (0.21%)	2	2/936 (0.21%)	2
Miscellaneous - Drug reaction † 1	2/974 (0.21%)	2	6/936 (0.64%)	6
Miscellaneous - Other † 1	22/974 (2.26%)	28	23/936 (2.46%)	24
Miscellaneous - Suicide † 1	1/974 (0.10%)	1	0/936 (0.00%)	0
Multi organ failure † 1	4/974 (0.41%)	4	10/936 (1.07%)	10
Other † 1	70/974 (7.19%)	80	68/936 (7.26%)	72
Unknown cause of death † 1	21/974 (2.16%)	21	19/936 (2.03%)	19
Valve stenosis - Restenosis † 1	1/974 (0.10%)	1	1/936 (0.11%)	1
Valve thrombosis † 1	1/974 (0.10%)	1	0/936 (0.00%)	0
Infections and infestations
Infection - Access site infection † 1	16/974 (1.64%)	17	2/936 (0.21%)	2
Infection - Bacteremia † 1	14/974 (1.44%)	15	13/936 (1.39%)	14
Infection - Endocarditis † 1	14/974 (1.44%)	15	11/936 (1.18%)	11
Infection - Other † 1	37/974 (3.80%)	48	56/936 (5.98%)	67
Infection - Respiratory infection † 1	93/974 (9.55%)	110	100/936 (10.68%)	111
Infection - Sepsis † 1	41/974 (4.21%)	44	47/936 (5.02%)	52
Infection - Sternal wound infection † 1	1/974 (0.10%)	1	14/936 (1.50%)	18
Infection - Urinary tract infection † 1	40/974 (4.11%)	47	31/936 (3.31%)	36
Injury, poisoning and procedural complications
Access site and access related vascular injury - Aortic root rupture † 1	2/974 (0.21%)	2	2/936 (0.21%)	2
Access site and access related vascular injury - Dissection † 1	20/974 (2.05%)	21	8/936 (0.85%)	8
Access site/access related vascular injury - Distal embolization (noncerebral) from vascular source † 1	1/974 (0.10%)	1	0/936 (0.00%)	0
Access site/related vascular injury - Failure of perc access site closure causing intervention † 1	3/974 (0.31%)	3	0/936 (0.00%)	0
Access site and access related vascular injury - Hematoma † 1	2/974 (0.21%)	3	5/936 (0.53%)	5
Access site and access related vascular injury - Perforation † 1	9/974 (0.92%)	9	7/936 (0.75%)	7
Access site and access related vascular injury - Pseudoaneurysm † 1	10/974 (1.03%)	10	1/936 (0.11%)	1
Access site and access related vascular injury - Rupture † 1	3/974 (0.31%)	3	1/936 (0.11%)	1
Access site and access related vascular injury - Stenosis † 1	1/974 (0.10%)	1	0/936 (0.00%)	0
Access site and access related vascular injury - Ventricular rupture (Apical rupture) † 1	4/974 (0.41%)	4	1/936 (0.11%)	1
Anesthesia related complication - Aspiration † 1	1/974 (0.10%)	1	0/936 (0.00%)	0
Anesthesia related complication - Confusion † 1	0/974 (0.00%)	0	1/936 (0.11%)	1
Anesthesia related complication - Dysphasia † 1	0/974 (0.00%)	0	1/936 (0.11%)	1
Anesthesia related complication - Other † 1	3/974 (0.31%)	3	2/936 (0.21%)	2
Miscellaneous - Fall † 1	25/974 (2.57%)	26	32/936 (3.42%)	34
Investigations
Abnormal lab value † 1	24/974 (2.46%)	28	42/936 (4.49%)	46
Musculoskeletal and connective tissue disorders
Musculoskeletal - Fracture † 1	47/974 (4.83%)	51	43/936 (4.59%)	45
Musculoskeletal - Pain † 1	33/974 (3.39%)	35	32/936 (3.42%)	35
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Miscellaneous - Cancer † 1	27/974 (2.77%)	31	26/936 (2.78%)	28
Nervous system disorders
Encephalopathy † 1	7/974 (0.72%)	7	4/936 (0.43%)	4
Mental state change (not neurological) - Dementia † 1	7/974 (0.72%)	8	4/936 (0.43%)	5
Neurological - Change in level of consciousness † 1	0/974 (0.00%)	0	6/936 (0.64%)	6
Neurological - Dysphasia/Aphasia † 1	5/974 (0.51%)	6	0/936 (0.00%)	0
Neurological - Hemianopia (blindness in one half of the visual field) † 1	0/974 (0.00%)	0	2/936 (0.21%)	2
Neurological - Hemiparesis (One sided body weakness) † 1	1/974 (0.10%)	1	6/936 (0.64%)	6
Neurological - Hemiplegia (One side limb weakness) † 1	0/974 (0.00%)	0	3/936 (0.32%)	3
Neurological - Hemorrhagic stroke † 1	15/974 (1.54%)	15	11/936 (1.18%)	12
Neurological - Ischemic stroke † 1	57/974 (5.85%)	58	46/936 (4.91%)	47
Neurological - Other † 1	18/974 (1.85%)	20	24/936 (2.56%)	25
Neurological - Other new neurological sign consistent with stroke † 1	6/974 (0.62%)	6	4/936 (0.43%)	4
Neurological - Syncope † 1	2/974 (0.21%)	2	1/936 (0.11%)	1
Neurological - TIA † 1	22/974 (2.26%)	23	14/936 (1.50%)	15
Neurological - Undetermined stroke † 1	9/974 (0.92%)	9	5/936 (0.53%)	5
Psychiatric disorders
Delirium † 1	2/974 (0.21%)	2	2/936 (0.21%)	2
Mental state change (not neurological) - Confusion † 1	14/974 (1.44%)	14	14/936 (1.50%)	16
Mental state change (not neurological) - Depression † 1	2/974 (0.21%)	2	1/936 (0.11%)	1
Neurological - Cognitive impairment † 1	0/974 (0.00%)	0	3/936 (0.32%)	3
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic † 1	18/974 (1.85%)	18	10/936 (1.07%)	10
Renal insufficiency or renal failure † 1	48/974 (4.93%)	53	80/936 (8.55%)	88
Respiratory, thoracic and mediastinal disorders
Respiratory event - Aspiration † 1	4/974 (0.41%)	4	7/936 (0.75%)	10
Respiratory event - Atelectasis † 1	1/974 (0.10%)	1	1/936 (0.11%)	1
Respiratory event - Dyspnea † 1	18/974 (1.85%)	20	21/936 (2.24%)	24
Respiratory event - Other † 1	23/974 (2.36%)	25	18/936 (1.92%)	19
Respiratory event - Pneumothorax † 1	8/974 (0.82%)	8	16/936 (1.71%)	18
Respiratory event - Pulmonary edema † 1	6/974 (0.62%)	6	5/936 (0.53%)	5
Respiratory event - Pulmonary effusion † 1	33/974 (3.39%)	37	64/936 (6.84%)	81
Respiratory event - Respiratory failure † 1	50/974 (5.13%)	56	75/936 (8.01%)	92
Vascular disorders
Bleeding - Hemorrhage † 1	145/974 (14.89%)	167	248/936 (26.50%)	297
Embolization including air/calcific valve material or Thrombus † 1	15/974 (1.54%)	15	26/936 (2.78%)	27
Hypertension † 1	6/974 (0.62%)	6	3/936 (0.32%)	3
Hypotension † 1	14/974 (1.44%)	14	24/936 (2.56%)	25
Ischemia † 1	13/974 (1.33%)	20	21/936 (2.24%)	24
Syncope † 1	21/974 (2.16%)	22	20/936 (2.14%)	22
1 Term from vocabulary, MedDRA 10.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	PIIA: SAPIEN XT - 2 Year		Control: SAVR - 2 Year
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	838/974 (86.04%)		864/936 (92.31%)
Blood and lymphatic system disorders
Anemia/Hemolytic anemia † 1	168/974 (17.25%)	192	198/936 (21.15%)	219
Thrombocytopenia † 1	120/974 (12.32%)	126	210/936 (22.44%)	217
Cardiac disorders
Arrhythmia/Conduction system injury (defect) † 1	284/974 (29.16%)	338	409/936 (43.70%)	507
Heart failure/CHF/Low output failure † 1	71/974 (7.29%)	75	90/936 (9.62%)	101
Gastrointestinal disorders
Gastro Intestinal event - Non-hemorrhagic † 1	96/974 (9.86%)	108	125/936 (13.35%)	157
General disorders
Edema † 1	39/974 (4.00%)	40	53/936 (5.66%)	56
Miscellaneous - Other † 1	62/974 (6.37%)	72	67/936 (7.16%)	81
Other † 1	165/974 (16.94%)	213	175/936 (18.70%)	221
Infections and infestations
Infection - Other † 1	86/974 (8.83%)	96	84/936 (8.97%)	96
Infection - Respiratory infection † 1	98/974 (10.06%)	112	101/936 (10.79%)	118
Infection - Urinary tract infection † 1	133/974 (13.66%)	164	165/936 (17.63%)	198
Injury, poisoning and procedural complications
Miscellaneous - Fall † 1	80/974 (8.21%)	94	66/936 (7.05%)	76
Investigations
Abnormal lab value † 1	187/974 (19.20%)	260	257/936 (27.46%)	404
Musculoskeletal and connective tissue disorders
Musculoskeletal - Pain † 1	100/974 (10.27%)	121	90/936 (9.62%)	108
Psychiatric disorders
Mental state change (not neurological) - Confusion † 1	39/974 (4.00%)	42	63/936 (6.73%)	65
Renal and urinary disorders
Genito-Urinary event - Non-hemorrhagic † 1	47/974 (4.83%)	54	58/936 (6.20%)	64
Renal insufficiency or renal failure † 1	214/974 (21.97%)	254	258/936 (27.56%)	297
Respiratory, thoracic and mediastinal disorders
Respiratory event - Atelectasis † 1	37/974 (3.80%)	37	51/936 (5.45%)	51
Respiratory event - Pneumothorax † 1	4/974 (0.41%)	4	47/936 (5.02%)	49
Respiratory Event - Pulmonary Effusion † 1	70/974 (7.19%)	75	178/936 (19.02%)	191
Vascular disorders
Bleeding - Hemorrhage † 1	285/974 (29.26%)	345	421/936 (44.98%)	500
Hypertension † 1	74/974 (7.60%)	75	48/936 (5.13%)	49
Hypotension † 1	56/974 (5.75%)	62	97/936 (10.36%)	102
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

• Name/Title: Tenley Koepnick
• Organization: Edwards Lifesciences
• EMail: Tenley_Koepnick@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.

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.

Abbas AE, Ternacle J, Pibarot P, Xu K, Alu M, Rogers E, Hahn RT, Leon M, Thourani VH. Impact of Flow on Prosthesis-Patient Mismatch Following Transcatheter and Surgical Aortic Valve Replacement. Circ Cardiovasc Imaging. 2021 Aug;14(8):e012364. doi: 10.1161/CIRCIMAGING.120.012364. Epub 2021 Aug 13.

Cremer PC, Wang TKM, Rodriguez LL, Lindman BR, Zhang Y, Zajarias A, Hahn RT, Lerakis S, Malaisrie SC, Douglas PS, Pibarot P, Svensson LG, Kapadia S, Leon MB, Jaber WA; PARTNER II Investigators. Incidence and Clinical Significance of Worsening Tricuspid Regurgitation Following Surgical or Transcatheter Aortic Valve Replacement: Analysis From the PARTNER IIA Trial. Circ Cardiovasc Interv. 2021 Aug;14(8):e010437. doi: 10.1161/CIRCINTERVENTIONS.120.010437. Epub 2021 Jul 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.

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.

Makkar RR, Thourani VH, Mack MJ, Kodali SK, Kapadia S, Webb JG, Yoon SH, Trento A, Svensson LG, Herrmann HC, Szeto WY, Miller DC, Satler L, Cohen DJ, Dewey TM, Babaliaros V, Williams MR, Kereiakes DJ, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Brown DL, Fearon WF, Russo MJ, Pibarot P, Hahn RT, Jaber WA, Rogers E, Xu K, Wheeler J, Alu MC, Smith CR, Leon MB; PARTNER 2 Investigators. Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement. N Engl J Med. 2020 Jan 29;382(9):799-809. doi: 10.1056/NEJMoa1910555. Print 2020 Feb 27.

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.

Chakravarty T, Patel A, Kapadia S, Raschpichler M, Smalling RW, Szeto WY, Abramowitz Y, Cheng W, Douglas PS, Hahn RT, Herrmann HC, Kereiakes D, Svensson L, Yoon SH, Babaliaros VC, Kodali S, Thourani VH, Alu MC, Liu Y, McAndrew T, Mack M, Leon MB, Makkar RR. Anticoagulation After Surgical or Transcatheter Bioprosthetic Aortic Valve Replacement. J Am Coll Cardiol. 2019 Sep 3;74(9):1190-1200. doi: 10.1016/j.jacc.2019.06.058.

Baron SJ, Wang K, House JA, Magnuson EA, Reynolds MR, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Mack MJ, Brown DL, Russo MJ, Smith CR, Webb J, Miller C, Leon MB, Cohen DJ. Cost-Effectiveness of Transcatheter Versus Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Risk. Circulation. 2019 Feb 12;139(7):877-888. doi: 10.1161/CIRCULATIONAHA.118.035236.

Pibarot P, Hahn RT, Weissman NJ, Arsenault M, Beaudoin J, Bernier M, Dahou A, Khalique OK, Asch FM, Toubal O, Leipsic J, Blanke P, Zhang F, Parvataneni R, Alu M, Herrmann H, Makkar R, Mack M, Smalling R, Leon M, Thourani VH, Kodali S. Association of Paravalvular Regurgitation With 1-Year Outcomes After Transcatheter Aortic Valve Replacement With the SAPIEN 3 Valve. JAMA Cardiol. 2017 Nov 1;2(11):1208-1216. doi: 10.1001/jamacardio.2017.3425.

Baron SJ, Arnold SV, Wang K, Magnuson EA, Chinnakondepali K, Makkar R, Herrmann HC, Kodali S, Thourani VH, Kapadia S, Svensson L, Brown DL, Mack MJ, Smith CR, Leon MB, Cohen DJ; PARTNER 2 Investigators. Health Status Benefits of Transcatheter vs Surgical Aortic Valve Replacement in Patients With Severe Aortic Stenosis at Intermediate Surgical Risk: Results From the PARTNER 2 Randomized Clinical Trial. JAMA Cardiol. 2017 Aug 1;2(8):837-845. doi: 10.1001/jamacardio.2017.2039.

Webb JG, Mack MJ, White JM, Dvir D, Blanke P, Herrmann HC, Leipsic J, Kodali SK, Makkar R, Miller DC, Pibarot P, Pichard A, Satler LF, Svensson L, Alu MC, Suri RM, Leon MB. Transcatheter Aortic Valve Implantation Within Degenerated Aortic Surgical Bioprostheses: PARTNER 2 Valve-in-Valve Registry. J Am Coll Cardiol. 2017 May 9;69(18):2253-2262. doi: 10.1016/j.jacc.2017.02.057.

Blanke P, Pibarot P, Hahn R, Weissman N, Kodali S, Thourani V, Parvataneni R, Dvir D, Naoum C, Norgaard BL, Douglas P, Jaber W, Khalique OK, Jilaihawi H, Mack M, Smith C, Leon M, Webb J, Leipsic J. Computed Tomography-Based Oversizing Degrees and Incidence of Paravalvular Regurgitation of a New Generation Transcatheter Heart Valve. JACC Cardiovasc Interv. 2017 Apr 24;10(8):810-820. doi: 10.1016/j.jcin.2017.02.021.

Herrmann HC, Thourani VH, Kodali SK, Makkar RR, Szeto WY, Anwaruddin S, Desai N, Lim S, Malaisrie SC, Kereiakes DJ, Ramee S, Greason KL, Kapadia S, Babaliaros V, Hahn RT, Pibarot P, Weissman NJ, Leipsic J, Whisenant BK, Webb JG, Mack MJ, Leon MB; PARTNER Investigators. One-Year Clinical Outcomes With SAPIEN 3 Transcatheter Aortic Valve Replacement in High-Risk and Inoperable Patients With Severe Aortic Stenosis. Circulation. 2016 Jul 12;134(2):130-40. doi: 10.1161/CIRCULATIONAHA.116.022797.

Kodali S, Thourani VH, White J, Malaisrie SC, Lim S, Greason KL, Williams M, Guerrero M, Eisenhauer AC, Kapadia S, Kereiakes DJ, Herrmann HC, Babaliaros V, Szeto WY, Hahn RT, Pibarot P, Weissman NJ, Leipsic J, Blanke P, Whisenant BK, Suri RM, Makkar RR, Ayele GM, Svensson LG, Webb JG, Mack MJ, Smith CR, Leon MB. Early clinical and echocardiographic outcomes after SAPIEN 3 transcatheter aortic valve replacement in inoperable, high-risk and intermediate-risk patients with aortic stenosis. Eur Heart J. 2016 Jul 21;37(28):2252-62. doi: 10.1093/eurheartj/ehw112. Epub 2016 Mar 31.

Leon MB, Smith CR, Mack MJ, Makkar RR, Svensson LG, Kodali SK, Thourani VH, Tuzcu EM, Miller DC, Herrmann HC, Doshi D, Cohen DJ, Pichard AD, Kapadia S, Dewey T, Babaliaros V, Szeto WY, Williams MR, Kereiakes D, Zajarias A, Greason KL, Whisenant BK, Hodson RW, Moses JW, Trento A, Brown DL, Fearon WF, Pibarot P, Hahn RT, Jaber WA, Anderson WN, Alu MC, Webb JG; PARTNER 2 Investigators. Transcatheter or Surgical Aortic-Valve Replacement in Intermediate-Risk Patients. N Engl J Med. 2016 Apr 28;374(17):1609-20. doi: 10.1056/NEJMoa1514616. Epub 2016 Apr 2.

Webb JG, Doshi D, Mack MJ, Makkar R, Smith CR, Pichard AD, Kodali S, Kapadia S, Miller DC, Babaliaros V, Thourani V, Herrmann HC, Bodenhamer M, Whisenant BK, Ramee S, Maniar H Jr, Kereiakes D, Xu K, Jaber WA, Menon V, Tuzcu EM, Wood D, Svensson LG, Leon MB. A Randomized Evaluation of the SAPIEN XT Transcatheter Heart Valve System in Patients With Aortic Stenosis Who Are Not Candidates for Surgery. JACC Cardiovasc Interv. 2015 Dec 21;8(14):1797-806. doi: 10.1016/j.jcin.2015.08.017.

Haussig S, Linke A. Patient selection for TAVI 2015 - TAVI in low-risk patients: fact or fiction? EuroIntervention. 2015 Sep;11 Suppl W:W86-91. doi: 10.4244/EIJV11SWA27.

Lindman BR, Maniar HS, Jaber WA, Lerakis S, Mack MJ, Suri RM, Thourani VH, Babaliaros V, Kereiakes DJ, Whisenant B, Miller DC, Tuzcu EM, Svensson LG, Xu K, Doshi D, Leon MB, Zajarias A. Effect of tricuspid regurgitation and the right heart on survival after transcatheter aortic valve replacement: insights from the Placement of Aortic Transcatheter Valves II inoperable cohort. Circ Cardiovasc Interv. 2015 Apr;8(4):10.1161/CIRCINTERVENTIONS.114.002073 e002073. doi: 10.1161/CIRCINTERVENTIONS.114.002073.

• Responsible Party: Edwards Lifesciences
• ClinicalTrials.gov Identifier: NCT01314313
• Other Study ID Numbers: 2010-12 PIIA
• First Submitted: March 7, 2011
• First Posted: March 14, 2011
• Results First Submitted: September 16, 2016
• Results First Posted: August 14, 2018
• Last Update Posted: March 7, 2024