Trial Outcomes & Findings for Vest Prevention of Early Sudden Death Trial and VEST Registry (NCT NCT01446965)
NCT ID: NCT01446965
Last Updated: 2021-01-20
Results Overview
For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2348 participants
Primary outcome timeframe
three months after myocardial infarction
Results posted on
2021-01-20
Participant Flow
From July 2008 through April 2017, the investigators enrolled 2348 participants at 76 sites in the United States, at 24 in Poland, at 6 in Germany, and at 2 in Hungary. One U.S. site was dismissed on June 24, 2014, and the 46 participants at that site were excluded from the analyses, due to irregularities found by the institutional review board at the site. Thus, a total of 2302 participants were included in the analyses (1524 participants in the device group and 778 in the control group).
Participant milestones
| Measure |
Wearable Defibrillator
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (WCD) (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
Randominization
STARTED
|
1554
|
794
|
|
Randominization
COMPLETED
|
1524
|
778
|
|
Randominization
NOT COMPLETED
|
30
|
16
|
|
Participants Followed and Analyzed
STARTED
|
1524
|
778
|
|
Participants Followed and Analyzed
Received WCD
|
1481
|
0
|
|
Participants Followed and Analyzed
Never Wore WCD
|
43
|
0
|
|
Participants Followed and Analyzed
Never Given WCD
|
0
|
758
|
|
Participants Followed and Analyzed
Given WCD Out of Protocol
|
0
|
20
|
|
Participants Followed and Analyzed
COMPLETED
|
1514
|
766
|
|
Participants Followed and Analyzed
NOT COMPLETED
|
10
|
12
|
Reasons for withdrawal
| Measure |
Wearable Defibrillator
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (WCD) (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
Randominization
One site was dismissed due to IRB irregularity
|
30
|
16
|
|
Participants Followed and Analyzed
Lost to Follow-up
|
10
|
12
|
Baseline Characteristics
Sex data not available for all randomized
Baseline characteristics by cohort
| Measure |
Wearable Defibrillator
n=1524 Participants
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
n=778 Participants
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
Total
n=2302 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.9 years
STANDARD_DEVIATION 12.6 • n=1524 Participants
|
61.4 years
STANDARD_DEVIATION 12.4 • n=778 Participants
|
61.2 years
STANDARD_DEVIATION 12.6 • n=2302 Participants
|
|
Sex: Female, Male
Female
|
413 Participants
n=1521 Participants • Sex data not available for all randomized
|
195 Participants
n=772 Participants • Sex data not available for all randomized
|
608 Participants
n=2293 Participants • Sex data not available for all randomized
|
|
Sex: Female, Male
Male
|
1108 Participants
n=1521 Participants • Sex data not available for all randomized
|
577 Participants
n=772 Participants • Sex data not available for all randomized
|
1685 Participants
n=2293 Participants • Sex data not available for all randomized
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
25 Participants
n=1524 Participants
|
12 Participants
n=778 Participants
|
37 Participants
n=2302 Participants
|
|
Race (NIH/OMB)
Asian
|
23 Participants
n=1524 Participants
|
14 Participants
n=778 Participants
|
37 Participants
n=2302 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=1524 Participants
|
0 Participants
n=778 Participants
|
1 Participants
n=2302 Participants
|
|
Race (NIH/OMB)
Black or African American
|
143 Participants
n=1524 Participants
|
75 Participants
n=778 Participants
|
218 Participants
n=2302 Participants
|
|
Race (NIH/OMB)
White
|
1279 Participants
n=1524 Participants
|
636 Participants
n=778 Participants
|
1915 Participants
n=2302 Participants
|
|
Race (NIH/OMB)
More than one race
|
20 Participants
n=1524 Participants
|
14 Participants
n=778 Participants
|
34 Participants
n=2302 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
33 Participants
n=1524 Participants
|
27 Participants
n=778 Participants
|
60 Participants
n=2302 Participants
|
|
Left ventricular ejection fraction
|
28.2 percentage of total amount of blood
STANDARD_DEVIATION 6.1 • n=1524 Participants
|
28.2 percentage of total amount of blood
STANDARD_DEVIATION 5.8 • n=778 Participants
|
28.2 percentage of total amount of blood
STANDARD_DEVIATION 6.1 • n=2302 Participants
|
PRIMARY outcome
Timeframe: three months after myocardial infarctionPopulation: A total of 2302 participants were included in the analyses.
For witnessed deaths, sudden cardiac death will be defined as an unexpected non-traumatic, non-self-inflicted fatality in otherwise stable participants who die within one hour of the onset of the terminal symptoms. For unwitnessed deaths, participants will meet the definition of sudden death if they are found dead within 24 hours of being well, assuming there is no evidence of another cause of death during that time period.
Outcome measures
| Measure |
Wearable Defibrillator
n=1524 Participants
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
n=778 Participants
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
Sudden Death Mortality
|
25 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: three months after myocardial infarctionAll deaths, due to any cause
Outcome measures
| Measure |
Wearable Defibrillator
n=1524 Participants
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
n=778 Participants
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
All Cause Mortality
|
48 Participants
|
38 Participants
|
SECONDARY outcome
Timeframe: three months after myocardial infarctionPopulation: Conventional treatment participants did not wear defibrillator.
daily wear time of the device
Outcome measures
| Measure |
Wearable Defibrillator
n=1524 Participants
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
Compliance With Wearable Defibrillator Use
|
18 hours per day
Interval 3.8 to 22.7
|
—
|
Adverse Events
Wearable Defibrillator
Serious events: 475 serious events
Other events: 1421 other events
Deaths: 48 deaths
Conventional Treatment
Serious events: 253 serious events
Other events: 714 other events
Deaths: 38 deaths
Serious adverse events
| Measure |
Wearable Defibrillator
n=1524 participants at risk
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
n=778 participants at risk
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
Cardiac disorders
CHD hospitalization, 1st event post-randomization
|
31.2%
475/1524 • Number of events 475 • 3 months
|
32.5%
253/778 • Number of events 253 • 3 months
|
Other adverse events
| Measure |
Wearable Defibrillator
n=1524 participants at risk
subjects in the Device Group will receive a LifeVest® wearable cardioverter-defibrillator (manufacturer: ZOLL Medical Corporation) plus guideline-directed medical therapy for post-myocardial infarction patients
wearable defibrillator: LifeVest wearable defibrillator
|
Conventional Treatment
n=778 participants at risk
subjects in the Control Group will only receive guideline-directed medical therapy for post-myocardial infarction patients
|
|---|---|---|
|
General disorders
Fatigue
|
33.5%
510/1524 • 3 months
|
35.2%
274/778 • 3 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
18.6%
283/1524 • 3 months
|
17.6%
137/778 • 3 months
|
|
General disorders
Trouble sleeping
|
36.2%
551/1524 • 3 months
|
33.9%
264/778 • 3 months
|
|
General disorders
Dizziness
|
22.6%
344/1524 • 3 months
|
21.3%
166/778 • 3 months
|
|
General disorders
Fainting
|
3.9%
59/1524 • 3 months
|
4.6%
36/778 • 3 months
|
|
Gastrointestinal disorders
Nausea
|
8.7%
132/1524 • 3 months
|
10.9%
85/778 • 3 months
|
|
General disorders
Headache
|
17.0%
259/1524 • 3 months
|
17.5%
136/778 • 3 months
|
|
Cardiac disorders
Palpitations
|
21.5%
327/1524 • 3 months
|
23.4%
182/778 • 3 months
|
|
Cardiac disorders
Chest pain
|
17.4%
265/1524 • 3 months
|
19.4%
151/778 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
36.0%
548/1524 • 3 months
|
41.3%
321/778 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash in any location
|
14.2%
216/1524 • 3 months
|
6.4%
50/778 • 3 months
|
|
Skin and subcutaneous tissue disorders
Rash on torso
|
12.1%
184/1524 • 3 months
|
3.5%
27/778 • 3 months
|
|
Skin and subcutaneous tissue disorders
Itch in any location
|
15.9%
243/1524 • 3 months
|
5.8%
45/778 • 3 months
|
|
Skin and subcutaneous tissue disorders
Itch on torso
|
13.5%
205/1524 • 3 months
|
2.8%
22/778 • 3 months
|
Additional Information
Jeffrey Olgin, MD
University of California, San Francisco
Phone: 415-476-1000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place