Trial Outcomes & Findings for PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk (NCT NCT01314313)

NCT ID: NCT01314313

Last Updated: 2024-03-07

Results Overview

All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)

Recruitment status

COMPLETED

Study phase

Target enrollment

2032 participants

Primary outcome timeframe

2 Years

Results posted on

2024-03-07

Participant Flow

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.

Participant milestones

Participant milestones
Measure	PIIA: SAPIEN XT Edwards SAPIEN XT Transcatheter Heart Valve (THV) NOTE: SAVR with surgical bioprosthetic heart valve is the control arm.	Control: SAVR Surgical Aortic Valve Replacement (SAVR)
Overall Study STARTED	1011	1021
Overall Study As Treated	994	944
Overall Study Valve Implanted	974	936
Overall Study COMPLETED	784	710
Overall Study NOT COMPLETED	227	311

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PARTNER II Trial: Placement of AoRTic TraNscathetER Valves II - XT Intermediate and High Risk

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	PIIA: SAPIEN XT n=1011 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=1021 Participants Surgical Aortic Valve Replacement (SAVR); Control for PIIA: SAPIEN XT	Total n=2032 Participants Total of all reporting groups
Age, Continuous	81.5 years STANDARD_DEVIATION 6.70 • n=5 Participants	81.7 years STANDARD_DEVIATION 6.71 • n=7 Participants	81.6 years STANDARD_DEVIATION 6.70 • n=5 Participants
Sex: Female, Male Female	463 Participants n=5 Participants	461 Participants n=7 Participants	924 Participants n=5 Participants
Sex: Female, Male Male	548 Participants n=5 Participants	560 Participants n=7 Participants	1108 Participants n=5 Participants
STS Score	5.8 % risk of mortality or morbidity STANDARD_DEVIATION 2.08 • n=5 Participants	5.8 % risk of mortality or morbidity STANDARD_DEVIATION 1.87 • n=7 Participants	5.8 % risk of mortality or morbidity STANDARD_DEVIATION 1.98 • n=5 Participants
NYHA Classification NYHA I/II	229 participants n=5 Participants	244 participants n=7 Participants	473 participants n=5 Participants
NYHA Classification NYHA III/VI	782 participants n=5 Participants	776 participants n=7 Participants	1558 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 Years

Population: Participants include all patients who were randomized.

All-cause Death or Disabling Stroke (Edwards SAPIEN XT THV vs SAVR)

Outcome measures

Outcome measures
Measure	PIIA: SAPIEN XT n=1011 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=1021 Participants Control: Surgical Aortic Valve Replacement (SAVR)
All-cause Death or Disabling Stroke to Two Years	192 Participants	202 Participants

SECONDARY outcome

Timeframe: 2 years

Population: 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.

The number of days the patients are alive and out of the hospital.

Outcome measures

Outcome measures
Measure	PIIA: SAPIEN XT n=998 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=953 Participants Control: Surgical Aortic Valve Replacement (SAVR)
Adjusted Days Alive and Out of Hospital (DAOH) to Two Years	629.4 days Standard Deviation 208.54	597.8 days Standard Deviation 236.80

SECONDARY outcome

Timeframe: 2 years

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

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.

Outcome measures

Outcome measures
Measure	PIIA: SAPIEN XT n=606 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=520 Participants Control: Surgical Aortic Valve Replacement (SAVR)
Total Aortic Regurgitation (AR) at 2 Years	1.2 Grade Standard Deviation 1.0	0.5 Grade Standard Deviation 0.7

SECONDARY outcome

Timeframe: Baseline and 2 years

Six Minute Walk Test change from baseline to 2 years

Outcome measures

Outcome measures
Measure	PIIA: SAPIEN XT n=604 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=1021 Participants Control: Surgical Aortic Valve Replacement (SAVR)
6MWT Change From Baseline	14.5 meters Standard Deviation 128.7	NA meters Standard Deviation NA This secondary endpoint analyzes change within the SAPIEN XT Cohort.

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures
Measure	PIIA: SAPIEN XT n=737 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=649 Participants Control: Surgical Aortic Valve Replacement (SAVR)
NYHA Classification at 2 Years	1.5 units on a scale Standard Deviation 0.7	1.4 units on a scale Standard Deviation 0.6

SECONDARY outcome

Timeframe: 2 years

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

Outcome measures

Outcome measures
Measure	PIIA: SAPIEN XT n=573 Participants Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR n=490 Participants Control: Surgical Aortic Valve Replacement (SAVR)
Effective Orifice Area (EOA)	1.5 cm^2 Standard Deviation 0.4	1.4 cm^2 Standard Deviation 0.4

Adverse Events

PIIA: SAPIEN XT - 2 Year

Serious events: 666 serious events

Other events: 838 other events

Deaths: 166 deaths

Control: SAVR - 2 Year

Serious events: 672 serious events

Other events: 864 other events

Deaths: 170 deaths

Serious adverse events

Other adverse events

Additional Information

Tenley Koepnick

Edwards Lifesciences

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	PIIA: SAPIEN XT - 2 Year n=974 participants at risk Edwards SAPIEN XT Transcatheter Heart Valve (THV)	Control: SAVR - 2 Year n=936 participants at risk Surgical Aortic Valve Replacement (SAVR) NOTE: SAVR with surgical bioprosthetic heart valve is the control arm.
Investigations Abnormal lab value	19.2% 187/974 • Number of events 260 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	27.5% 257/936 • Number of events 404 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Blood and lymphatic system disorders Anemia/Hemolytic anemia	17.2% 168/974 • Number of events 192 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	21.2% 198/936 • Number of events 219 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Cardiac disorders Arrhythmia/Conduction system injury (defect)	29.2% 284/974 • Number of events 338 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	43.7% 409/936 • Number of events 507 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Vascular disorders Bleeding - Hemorrhage	29.3% 285/974 • Number of events 345 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	45.0% 421/936 • Number of events 500 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
General disorders Edema	4.0% 39/974 • Number of events 40 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.7% 53/936 • Number of events 56 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Gastrointestinal disorders Gastro Intestinal event - Non-hemorrhagic	9.9% 96/974 • Number of events 108 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	13.4% 125/936 • Number of events 157 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Renal and urinary disorders Genito-Urinary event - Non-hemorrhagic	4.8% 47/974 • Number of events 54 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.2% 58/936 • Number of events 64 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Cardiac disorders Heart failure/CHF/Low output failure	7.3% 71/974 • Number of events 75 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	9.6% 90/936 • Number of events 101 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Vascular disorders Hypertension	7.6% 74/974 • Number of events 75 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.1% 48/936 • Number of events 49 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Vascular disorders Hypotension	5.7% 56/974 • Number of events 62 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	10.4% 97/936 • Number of events 102 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Infections and infestations Infection - Other	8.8% 86/974 • Number of events 96 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	9.0% 84/936 • Number of events 96 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Infections and infestations Infection - Respiratory infection	10.1% 98/974 • Number of events 112 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	10.8% 101/936 • Number of events 118 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Infections and infestations Infection - Urinary tract infection	13.7% 133/974 • Number of events 164 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	17.6% 165/936 • Number of events 198 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Psychiatric disorders Mental state change (not neurological) - Confusion	4.0% 39/974 • Number of events 42 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	6.7% 63/936 • Number of events 65 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Injury, poisoning and procedural complications Miscellaneous - Fall	8.2% 80/974 • Number of events 94 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	7.1% 66/936 • Number of events 76 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
General disorders Miscellaneous - Other	6.4% 62/974 • Number of events 72 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	7.2% 67/936 • Number of events 81 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Musculoskeletal and connective tissue disorders Musculoskeletal - Pain	10.3% 100/974 • Number of events 121 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	9.6% 90/936 • Number of events 108 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
General disorders Other	16.9% 165/974 • Number of events 213 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	18.7% 175/936 • Number of events 221 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Renal and urinary disorders Renal insufficiency or renal failure	22.0% 214/974 • Number of events 254 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	27.6% 258/936 • Number of events 297 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Respiratory, thoracic and mediastinal disorders Respiratory event - Atelectasis	3.8% 37/974 • Number of events 37 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.4% 51/936 • Number of events 51 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Respiratory, thoracic and mediastinal disorders Respiratory event - Pneumothorax	0.41% 4/974 • Number of events 4 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	5.0% 47/936 • Number of events 49 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Respiratory, thoracic and mediastinal disorders Respiratory Event - Pulmonary Effusion	7.2% 70/974 • Number of events 75 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	19.0% 178/936 • Number of events 191 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).
Blood and lymphatic system disorders Thrombocytopenia	12.3% 120/974 • Number of events 126 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).	22.4% 210/936 • Number of events 217 • Adverse event data are currently available and reported for all events at 2 years were reported at the time of database lock. Adverse Events are site reported. Only Valve-Implanted patients are reported for all adverse events (except for mortality).