Trial Outcomes & Findings for Trifecta™ Durability Study (NCT NCT01256710)

Last Updated: 2023-11-22

Results Overview

Percentage of participants free from surgical explant or valve-in-valve transcatheter aortic valve intervention for treatment of structural deterioration of the Trifecta™ valve through 10 years post-implant. This percentage is estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation.

Recruitment status

TERMINATED

Target enrollment

1151 participants

Primary outcome timeframe

10 years

Results posted on

2023-11-22

Participant Flow

Participant milestones

Participant milestones
Measure	Trifecta™ Valve Group Subjects implanted with the Trifecta™ aortic bioprosthesis
Overall Study STARTED	1151
Overall Study COMPLETED	227
Overall Study NOT COMPLETED	924

Reasons for withdrawal

Reasons for withdrawal
Measure	Trifecta™ Valve Group Subjects implanted with the Trifecta™ aortic bioprosthesis
Overall Study Death	449
Overall Study System Explant	67
Overall Study Transcatheter Aortic Valve-in-Valve Intervention	28
Overall Study Lost to Follow-up	67
Overall Study Withdrawal by Subject	29
Overall Study Physician Decision	9
Overall Study Subject Noncompliance	2
Overall Study Study Terminated by Sponsor	273

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Trifecta™ Valve Group n=1151 Participants Subjects implanted with the Trifecta™ aortic bioprosthesis
Age, Continuous	73.7 years STANDARD_DEVIATION 7.8 • n=1151 Participants
Sex: Female, Male Female	487 Participants n=1151 Participants
Sex: Female, Male Male	664 Participants n=1151 Participants
Region of Enrollment Austria	14 participants n=1151 Participants
Region of Enrollment Belgium	7 participants n=1151 Participants
Region of Enrollment Canada	54 participants n=1151 Participants
Region of Enrollment Denmark	17 participants n=1151 Participants
Region of Enrollment France	386 participants n=1151 Participants
Region of Enrollment Germany	404 participants n=1151 Participants
Region of Enrollment Greece	12 participants n=1151 Participants
Region of Enrollment Italy	12 participants n=1151 Participants
Region of Enrollment Netherlands	53 participants n=1151 Participants
Region of Enrollment Norway	4 participants n=1151 Participants
Region of Enrollment Portugal	4 participants n=1151 Participants
Region of Enrollment Spain	153 participants n=1151 Participants
Region of Enrollment Switzerland	20 participants n=1151 Participants
Region of Enrollment United Kingdom	11 participants n=1151 Participants
Baseline Characteristics Baseline NYHA III/IV	566 Participants n=1151 Participants
Baseline Characteristics History of Coronary Artery Disease	395 Participants n=1151 Participants
Baseline Characteristics History of Hypertension	912 Participants n=1151 Participants
Baseline Characteristics History of Diabetes	316 Participants n=1151 Participants
Baseline Characteristics Previous Cardiovascular Surgery or Procedure	222 Participants n=1151 Participants
Baseline Characteristics Concomitant Procedure (e.g., mitral or tricuspid valve repair, CABG, operator reported)	627 Participants n=1151 Participants
Baseline Characteristics Concomitant Coronary Artery Bypass Grafting	360 Participants n=1151 Participants
Implanted Device Size 19 mm	115 Participants n=1151 Participants
Implanted Device Size 21 mm	335 Participants n=1151 Participants
Implanted Device Size 23 mm	411 Participants n=1151 Participants
Implanted Device Size 25 mm	222 Participants n=1151 Participants
Implanted Device Size 27 mm	57 Participants n=1151 Participants
Implanted Device Size 29 mm	11 Participants n=1151 Participants

PRIMARY outcome

Timeframe: 10 years

Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.

Outcome measures

Outcome measures
Measure	Trifecta Valve™ Group n=1151 Participants Subjects implanted with the Trifecta™ aortic bioprosthesis
Actuarial Freedom From Reintervention Due to Structural Valve Deterioration	85.0 percentage of participants Interval 81.6 to 87.8

SECONDARY outcome

Timeframe: 10 years

Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.

Percentage of participants free of death from any cause through 10 years after implant with the Trifecta™ valve, estimated from time-to-event data using the Kaplan-Meier estimator.

Outcome measures

Outcome measures
Measure	Trifecta Valve™ Group n=1151 Participants Subjects implanted with the Trifecta™ aortic bioprosthesis
Actuarial Freedom From All-cause Mortality	52.2 percentage of participants Interval 48.6 to 55.8

SECONDARY outcome

Timeframe: 10 years

Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.

Percentage of participants free from death related to the Trifecta™ valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Valve-related mortality includes deaths due to any of the following events involving the study valve: structural valvular deterioration, nonstructural valve dysfunction, valve thrombosis, embolism, bleeding events, endocarditis, or reoperation. Sudden, unexplained deaths of participants implanted with the Trifecta™ valve are also counted as valve-related mortality.

Outcome measures

Outcome measures
Measure	Trifecta Valve™ Group n=1151 Participants Subjects implanted with the Trifecta™ aortic bioprosthesis
Freedom From Valve Related Mortality	81.6 percentage of participants Interval 78.1 to 84.6

SECONDARY outcome

Timeframe: 10 years

Population: The analysis population includes participants implanted with the Trifecta™ valve who met all study eligibility criteria and consented to be enrolled in the study.

Percentage of participants free of structural deterioration of the Trifecta valve through 10 years after implant, estimated from time-to-event data using the Kaplan-Meier estimator. Structural valve deterioration is deterioration intrinsic to the bioprosthetic valve, due to leaflet calcification, leaflet tears, or other causes, that results in prosthetic valve stenosis or regurgitation. The presence of structural valve deterioration is determined by direct visualization of the valve at explant or autopsy or by echocardiographic or other cardiac imaging criteria for assessment of valvular stenosis and regurgitation.

Outcome measures

Outcome measures
Measure	Trifecta Valve™ Group n=1151 Participants Subjects implanted with the Trifecta™ aortic bioprosthesis
Freedom From Structural Valve Deterioration	76.0 percentage of participants Interval 71.9 to 79.6

Adverse Events

Trifecta Valve Group

Serious events: 952 serious events

Other events: 562 other events

Deaths: 449 deaths

Serious adverse events

Serious adverse events
Measure	Trifecta Valve Group n=1151 participants at risk Implantation of the Trifecta Valve: Implantation of the bioprothesis valve, Trifecta Valve
Blood and lymphatic system disorders Blood and Lymphatic System Disorder	2.5% 29/1151 • Number of events 32 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Cardiac disorders Cardiac disorders	46.3% 533/1151 • Number of events 937 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Congenital, familial and genetic disorders Congenital, Familial and Genetic Disorders	0.09% 1/1151 • Number of events 1 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Ear and labyrinth disorders Ear and Labyrinth Disorders	0.52% 6/1151 • Number of events 6 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Endocrine disorders Endocrine Disorder	0.43% 5/1151 • Number of events 6 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Eye disorders Eye Disorders	1.9% 22/1151 • Number of events 24 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Gastrointestinal disorders Gastrointestinal Disorder	8.0% 92/1151 • Number of events 124 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
General disorders General Disorders	10.5% 121/1151 • Number of events 129 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Hepatobiliary disorders Hepatobiliary Disorders	3.2% 37/1151 • Number of events 47 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Immune system disorders Immune System Disorders	0.09% 1/1151 • Number of events 1 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Infections and infestations Infections and Infestations	23.1% 266/1151 • Number of events 355 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Injury, poisoning and procedural complications Injury, Poisoning and Procedural Complications	8.8% 101/1151 • Number of events 114 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Investigations Investigations	0.35% 4/1151 • Number of events 4 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Metabolism and nutrition disorders Metabolism and Nutrition Disorder	1.9% 22/1151 • Number of events 25 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Musculoskeletal and connective tissue disorders Musculoskeletal and Connective Tissue Disorders	9.0% 104/1151 • Number of events 117 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasms, Benign, Malignant and Unspecified Tumor	11.5% 132/1151 • Number of events 171 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Nervous system disorders Nervous System Disorder	12.5% 144/1151 • Number of events 175 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Product Issues Product Issues	0.78% 9/1151 • Number of events 9 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Psychiatric disorders Psychiatric Disorder	3.0% 35/1151 • Number of events 39 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Renal and urinary disorders Renal and Urinary Disorder	8.7% 100/1151 • Number of events 140 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Reproductive system and breast disorders Reproductive System and Breast Disorder	1.5% 17/1151 • Number of events 21 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Respiratory, thoracic and mediastinal disorders Respiratory, Thoracic and Mediastinal Disorder	18.1% 208/1151 • Number of events 283 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Skin and subcutaneous tissue disorders Skin and Subcutaneous Tissue Disorder	0.87% 10/1151 • Number of events 10 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Social circumstances Social Circumstances	0.43% 5/1151 • Number of events 5 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Surgical and medical procedures Surgical and Medical Procedures	1.8% 21/1151 • Number of events 22 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Vascular disorders Vascular Disorder	15.6% 180/1151 • Number of events 247 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.

Other adverse events

Other adverse events
Measure	Trifecta Valve Group n=1151 participants at risk Implantation of the Trifecta Valve: Implantation of the bioprothesis valve, Trifecta Valve
Cardiac disorders Cardiac Disorder	33.8% 389/1151 • Number of events 518 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	10.9% 126/1151 • Number of events 142 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.
Vascular disorders Vascular disorders	6.6% 76/1151 • Number of events 85 • 10 years Non-serious adverse events had limited analysis during the study focusing on cardiovascular and neurovascular events.

Additional Information

Yunlong (Phil) Zhang, MD, MS, Clinical Consultant

Abbott Medical Devices, Structure Heart Valves

Phone: 669-203-9308

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place