Trial Outcomes & Findings for ADVANCE Direct Aortic Study (NCT NCT01676727)

NCT ID: NCT01676727

Last Updated: 2018-09-19

Results Overview

Kaplan-Meier estimate of 30-day all-cause mortality.

• Recruitment status: COMPLETED
• Target enrollment: 100 participants
• Primary outcome timeframe: 30 days post-implant
• Results posted on: 2018-09-19

Participant Flow

Participant milestones

Measure	All Enrolled All subjects enrolled in the trial
Overall Study STARTED	100
Overall Study Implanted	92
Overall Study COMPLETED	68
Overall Study NOT COMPLETED	32

Reasons for withdrawal

Measure	All Enrolled All subjects enrolled in the trial
Overall Study Death	18
Overall Study Withdrawal by Subject	6
Overall Study Screening failure	5
Overall Study Not willing to attend 1-year visit	2
Overall Study Valve explanted	1

Baseline Characteristics

ADVANCE Direct Aortic Study

Baseline characteristics by cohort

Measure	All Enrolled n=100 Participants All subjects enrolled in the trial
Age, Continuous	81.9 years STANDARD_DEVIATION 5.9 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	52 Participants n=5 Participants
Region of Enrollment Czech Republic	20 participants n=5 Participants
Region of Enrollment Netherlands	18 participants n=5 Participants
Region of Enrollment United Kingdom	7 participants n=5 Participants
Region of Enrollment Italy	33 participants n=5 Participants
Region of Enrollment France	15 participants n=5 Participants
Region of Enrollment Germany	7 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days post-implant

Population: all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach

Kaplan-Meier estimate of 30-day all-cause mortality.

Outcome measures

Measure	Implanted Population n=92 Participants All subjects who were implanted with the CoreValve.
All-cause Mortality	4.4 Percentage of subjects Interval 1.4 to 10.0

SECONDARY outcome

Timeframe: 1, 6 and 12 months

Population: all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach

The combined safety endpoint is defined as a composite of:

• All-cause mortality
• All stroke
• Life-threatening bleeding
• Acute kidney injury-Stage 3 (including renal replacement therapy)
• Coronary artery obstruction requiring intervention
• Major vascular complication
• Valve-related dysfunction requiring repeat procedure (BAV, TAVR, or SAVR)
• High degree AV block requiring permanent pacemaker implantation

Outcome measures

Measure	Implanted Population n=92 Participants All subjects who were implanted with the CoreValve.
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) 1 month	7.6 Percentage of subjects Interval 3.4 to 14.2
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) 6 months	17.6 Percentage of subjects Interval 10.6 to 26.1
Kaplan-Meier Estimate of Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) 12 months	19.9 Percentage of subjects Interval 11.7 to 29.6

Adverse Events

Implanted Population

Serious events: 72 serious events

Other events: 68 other events

Deaths: 16 deaths

Serious adverse events

Measure	Implanted Population n=92 participants at risk all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach
Vascular disorders Stroke-TIA	3.3% 3/92 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
Vascular disorders Bleeding	26.1% 24/92 • Number of events 34 • Adverse event data were collected up to 1 year post-implant procedure.
Cardiac disorders Myocardial Infarction	1.1% 1/92 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
Renal and urinary disorders Renal Failure	13.0% 12/92 • Number of events 12 • Adverse event data were collected up to 1 year post-implant procedure.
Cardiac disorders New or worsened conduction disturbances and arrhythmias without pacemaker implant	12.0% 11/92 • Number of events 13 • Adverse event data were collected up to 1 year post-implant procedure.
Surgical and medical procedures Permanent Pacemaker Implantation	14.1% 13/92 • Number of events 13 • Adverse event data were collected up to 1 year post-implant procedure.
Injury, poisoning and procedural complications Vascular access site and access-related complications	16.3% 15/92 • Number of events 17 • Adverse event data were collected up to 1 year post-implant procedure.
Cardiac disorders Failure of current therapy for AS requiring hospitalization or worsening congestive heart failure	10.9% 10/92 • Number of events 13 • Adverse event data were collected up to 1 year post-implant procedure.
Surgical and medical procedures Sternotomy or thoracotomy related event	2.2% 2/92 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
General disorders	59.8% 55/92 • Number of events 103 • Adverse event data were collected up to 1 year post-implant procedure.
Cardiac disorders	3.3% 3/92 • Number of events 3 • Adverse event data were collected up to 1 year post-implant procedure.
Infections and infestations	2.2% 2/92 • Number of events 2 • Adverse event data were collected up to 1 year post-implant procedure.
Injury, poisoning and procedural complications	1.1% 1/92 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.

Other adverse events

Measure	Implanted Population n=92 participants at risk all subjects who underwent an attempted implant of whom all were implanted with the CoreValve device via the direct aortic approach
Injury, poisoning and procedural complications	1.1% 1/92 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
Cardiac disorders	33.7% 31/92 • Number of events 38 • Adverse event data were collected up to 1 year post-implant procedure.
General disorders	55.4% 51/92 • Number of events 93 • Adverse event data were collected up to 1 year post-implant procedure.
Product Issues	1.1% 1/92 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
Renal and urinary disorders	10.9% 10/92 • Number of events 11 • Adverse event data were collected up to 1 year post-implant procedure.
Infections and infestations	1.1% 1/92 • Number of events 1 • Adverse event data were collected up to 1 year post-implant procedure.
Surgical and medical procedures	4.3% 4/92 • Number of events 4 • Adverse event data were collected up to 1 year post-implant procedure.
Vascular disorders	15.2% 14/92 • Number of events 15 • Adverse event data were collected up to 1 year post-implant procedure.

Additional Information

Maarten Hollander

Medtronic Bakken Research Center

Phone: +31620534428

Email: Maarten.Hollander@medtronic.com

Results disclosure agreements

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

Restriction type: LTE60