Trial Outcomes & Findings for Randomized On-X Anticoagulation Trial (NCT NCT00291525)

NCT ID: NCT00291525

Last Updated: 2024-12-24

Results Overview

Percentage of events per patient year

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 977 participants
• Primary outcome timeframe: 8 years
• Results posted on: 2024-12-24

Participant Flow

Participant milestones

Measure	AVR Low Risk Without Warfarin AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Overall Study STARTED	99	102	185	190	201	200
Overall Study COMPLETED	19	74	81	112	132	120
Overall Study NOT COMPLETED	80	28	104	78	69	80

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	AVR Low Risk Without Warfarin n=99 Participants AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 Participants AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 Participants AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 Participants AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 Participants MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 Participants MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	Total n=977 Participants Total of all reporting groups
Age, Customized	53.5 years STANDARD_DEVIATION 10.9 • n=99 Participants	52.5 years STANDARD_DEVIATION 11.6 • n=102 Participants	54.1 years STANDARD_DEVIATION 13.0 • n=185 Participants	55.8 years STANDARD_DEVIATION 12.0 • n=190 Participants	55.0 years STANDARD_DEVIATION 11.2 • n=201 Participants	54.9 years STANDARD_DEVIATION 11.6 • n=200 Participants	54.3 years STANDARD_DEVIATION 11.7 • n=977 Participants
Sex: Female, Male Female	23 Participants n=99 Participants	26 Participants n=102 Participants	37 Participants n=185 Participants	36 Participants n=190 Participants	121 Participants n=201 Participants	124 Participants n=200 Participants	367 Participants n=977 Participants
Sex: Female, Male Male	76 Participants n=99 Participants	76 Participants n=102 Participants	148 Participants n=185 Participants	154 Participants n=190 Participants	80 Participants n=201 Participants	76 Participants n=200 Participants	610 Participants n=977 Participants
Race and Ethnicity Not Collected	—	—	—	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 8 years

Percentage of events per patient year

Outcome measures

Measure	AVR Low Risk Without Warfarin n=99 Participants AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 Participants AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 Participants AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 Participants AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 Participants MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 Participants MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Thromboembolism	4.86 %/patient years	0.29 %/patient years	2.43 %/patient years	1.74 %/patient years	2.48 %/patient years	2.08 %/patient years

PRIMARY outcome

Timeframe: 8 years

Population: Numbers in parentheses are Linearized Occurrence Rates (LOR)

Percentage of events per patient year

Outcome measures

Measure	AVR Low Risk Without Warfarin n=99 Participants AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 Participants AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 Participants AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 Participants AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 Participants MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 Participants MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Valve Thrombosis	0.69 %/patient years	0.87 %/patient years	0.21 %/patient years	0.37 %/patient years	0.46 %/patient years	0.40 %/patient years

PRIMARY outcome

Timeframe: 8 years

Percentage of events per patient year

Outcome measures

Measure	AVR Low Risk Without Warfarin n=99 Participants AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 Participants AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 Participants AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 Participants AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 Participants MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 Participants MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Bleeding Events	3.82 Linearized Occurrence Rates (LOR): %/pat	3.49 Linearized Occurrence Rates (LOR): %/pat	2.86 Linearized Occurrence Rates (LOR): %/pat	7.43 Linearized Occurrence Rates (LOR): %/pat	9.63 Linearized Occurrence Rates (LOR): %/pat	10.01 Linearized Occurrence Rates (LOR): %/pat

SECONDARY outcome

Timeframe: 8 years

Percentage of events per patient year

Outcome measures

Measure	AVR Low Risk Without Warfarin n=99 Participants AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 Participants AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 Participants AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 Participants AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 Participants MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 Participants MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Valve-Related Mortality	0.69 %/patient years	0.87 %/patient years	0.21 %/patient years	0.37 %/patient years	0.28 %/patient years	0.10 %/patient years

SECONDARY outcome

Timeframe: 5 years

Echocardiograpic measures of valve hemodynamics at 5 years

Outcome measures

Measure	AVR Low Risk Without Warfarin n=99 Participants AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 Participants AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 Participants AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 Participants AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 Participants MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 Participants MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Valve Hemodynamics Peak Gradient mmHg	22.64 mmHg Standard Deviation 11.74	21.31 mmHg Standard Deviation 12.24	15.8 mmHg Standard Deviation 9.8	16.7 mmHg Standard Deviation 8.5	11.9 mmHg Standard Deviation 4.4	12.6 mmHg Standard Deviation 7.5
Valve Hemodynamics Mean Gradient mmHg	11.38 mmHg Standard Deviation 6.25	11.00 mmHg Standard Deviation 5.87	7.6 mmHg Standard Deviation 5.0	8.8 mmHg Standard Deviation 4.2	4.6 mmHg Standard Deviation 1.93	4.7 mmHg Standard Deviation 1.98

Adverse Events

AVR Low Risk Without Warfarin

Serious events: 13 serious events

Other events: 0 other events

Deaths: 5 deaths

AVR Low Risk With Standard Warfarin

Serious events: 13 serious events

Other events: 0 other events

Deaths: 4 deaths

AVR High Risk With Lower Warfarin

Serious events: 38 serious events

Other events: 0 other events

Deaths: 10 deaths

AVR High Risk With Standard Warfarin

Serious events: 43 serious events

Other events: 0 other events

Deaths: 9 deaths

MVR With Lower Warfarin

Serious events: 94 serious events

Other events: 0 other events

Deaths: 17 deaths

MVR With Standard Warfarin

Serious events: 89 serious events

Other events: 0 other events

Deaths: 23 deaths

Serious adverse events

Measure	AVR Low Risk Without Warfarin n=99 participants at risk AVR Low Risk without warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR Low Risk With Standard Warfarin n=102 participants at risk AVR low risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	AVR High Risk With Lower Warfarin n=185 participants at risk AVR High risk with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	AVR High Risk With Standard Warfarin n=190 participants at risk AVR High Risk with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin	MVR With Lower Warfarin n=201 participants at risk MVR with lower warfarin On-X valve using reduced anticoagulation: Valve replacement with antiplatelet agents or lowered warfarin	MVR With Standard Warfarin n=200 participants at risk MVR with standard warfarin On-X Valve with Standard warfarin Therapy: Valve replacement with standard dosage warfarin
Cardiac disorders Paravaluvular Leak	1.0% 1/99 • Number of events 1 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	0.00% 0/102 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	1.6% 3/185 • Number of events 3 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	3.2% 6/190 • Number of events 6 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	2.5% 5/201 • Number of events 5 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	0.50% 1/200 • Number of events 1 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.
Cardiac disorders Endocarditis	1.0% 1/99 • Number of events 1 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	0.00% 0/102 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	2.2% 4/185 • Number of events 4 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	1.1% 2/190 • Number of events 2 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	1.5% 3/201 • Number of events 3 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	5.0% 10/200 • Number of events 10 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.
Cardiac disorders Congestive Heart Failure	1.0% 1/99 • Number of events 1 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	0.98% 1/102 • Number of events 1 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	2.2% 4/185 • Number of events 4 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	5.3% 10/190 • Number of events 10 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	15.4% 31/201 • Number of events 31 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	16.5% 33/200 • Number of events 33 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.
Cardiac disorders Other - Cardiovascular and Pulmonary	10.1% 10/99 • Number of events 10 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	11.8% 12/102 • Number of events 12 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	14.6% 27/185 • Number of events 27 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	13.2% 25/190 • Number of events 25 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	27.4% 55/201 • Number of events 55 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.	22.5% 45/200 • Number of events 45 • Events occurrence rate is presented for each arm at the end of its follow-up period. Time frame/Follow-up duration is different for each study arms (due to dependency on enrollment rate and timing of follow-up cessation at each arm): Aortic arm Low Risk: 8.6 years Aortic arm High Risk: 9.2 years Mitral arm: 14.7 Adverse events are reported as simple occurrence rates. "Other" Adverse Events were not collected in this study; only risks/events that are known as associated with heart valve replacement were reported and adjudicated (presented above). Classification of events was based on the AATS/STS guidelines categories and definitions rather than on serious/non-serious. The number of "Other" AEs is reported here as "0" because none were collected in the study.

Other adverse events

Adverse event data not reported

Additional Information

Clinical Project Manager (Yael Goode)

Artivion

Phone: 8454800137

Email: Yael.Goode@Artivion.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place