Trial Outcomes & Findings for The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts) (NCT NCT01943903)
NCT ID: NCT01943903
Last Updated: 2025-09-05
Results Overview
The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis \> 50% in a vessel \> 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR \< 0.80 in a segment distal to a stenosis in a vessel \> 2.0 mm by QCA between Cohort 1 and 2.
Recruitment status
COMPLETED
Target enrollment
584 participants
Primary outcome timeframe
90 Days from first test
Results posted on
2025-09-05
Participant Flow
Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of each subject considered for percutaneous coronary intervention (PCI) and/or coronary artery bypass grafting (CABG), the investigator and the institution's heart team will review clinical data and results of the diagnostic tests to recommend a treatment strategy, according to the institution's standard practice.
Patients were eligible for enrollment if they were symptomatic, had an intermediate likelihood of CAD, did not have an established diagnosis of CAD, and were referred for clinically indicated testing to evaluate CAD. Patients referred for noninvasive testing were enrolled in a separate stratum than patients referred for invasive testing. The choice to refer the patient for invasive testing rather than noninvasive testing was made by the local clinicians before enrollment in the study.
Participant milestones
| Measure |
Non-invasive (Cohort 2) Usual Care
(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly.
|
Non-invasive Cohort (Cohort 2) FFRCT
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
Invasive Cohort (Cohort 1) Usual Care
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
100
|
104
|
187
|
193
|
|
Overall Study
COMPLETED
|
100
|
104
|
187
|
193
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The PLATFORM Study: Prospective LongitudinAl Trial of FFRct: Outcome and Resource IMpacts)
Baseline characteristics by cohort
| Measure |
Invasive Cohort (Cohort 1) Usual Care
n=187 Participants
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 Participants
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
Non-invasive (Cohort 2) Usual Care
n=100 Participants
(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly.
|
Non-invasive Cohort (Cohort 2) FFRCT
n=104 Participants
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
Total
n=584 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.36 years
STANDARD_DEVIATION 10.93 • n=5 Participants
|
60.72 years
STANDARD_DEVIATION 10.20 • n=7 Participants
|
57.91 years
STANDARD_DEVIATION 10.72 • n=5 Participants
|
59.48 years
STANDARD_DEVIATION 9.33 • n=4 Participants
|
60.86 years
STANDARD_DEVIATION 10.54 • n=21 Participants
|
|
Sex: Female, Male
Female
|
79 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
44 Participants
n=4 Participants
|
231 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
108 Participants
n=5 Participants
|
119 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
353 Participants
n=21 Participants
|
|
Diabetes
|
36 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
80 Participants
n=21 Participants
|
|
Current smoker
|
42 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
125 Participants
n=21 Participants
|
|
Hypertension
|
111 Participants
n=5 Participants
|
111 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
57 Participants
n=4 Participants
|
317 Participants
n=21 Participants
|
|
Hyperlipidemia
|
76 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
203 Participants
n=21 Participants
|
|
Atypical angina
|
122 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
91 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
435 Participants
n=21 Participants
|
|
Prior noninvasive testing
|
92 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
197 Participants
n=21 Participants
|
|
Pre-test probability of CAD
|
97 Participants
n=5 Participants
|
95 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
47 Participants
n=4 Participants
|
295 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 90 Days from first testPopulation: ICA - Invasive coronary angiography. Independent core laboratories performed quantitative coronary angiography.
The primary endpoint of the PLATFORM Study is 90 day (+30/-15 days) rate of coronary angiogram showing no stenosis \> 50% in a vessel \> 2.0 mm by Quantitative Coronary Angiography (QCA), or no invasively-measured FFR \< 0.80 in a segment distal to a stenosis in a vessel \> 2.0 mm by QCA between Cohort 1 and 2.
Outcome measures
| Measure |
Planned Invasive Test Usual Care Strategy (Cohort 1B)
n=187 Participants
Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.
|
Planned Invasive Test FFRCT Guided Strategy (Cohort 2B)
n=193 Participants
Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.
|
Invasive Cohort (Cohort 1) Usual Care
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Number of Participants With Negative Invasive Coronary Angiography
|
137 Participants
|
24 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 90 days from first testPopulation: The analysis population was defined as all subjects who were enrolled into the study. Safety was monitored throughout the study. The low number of MACE events made it impossible to analyze the powered secondary endpoint. None of the events were related to the FFRCT.
90 days (+30/-30 days) Cohort 1 and Cohort 2 Major Adverse Coronary Event (MACE) rates, defined as: 1. All cause death 2. Non-fatal MI 3. Unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization
Outcome measures
| Measure |
Planned Invasive Test Usual Care Strategy (Cohort 1B)
n=100 Participants
Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.
|
Planned Invasive Test FFRCT Guided Strategy (Cohort 2B)
n=104 Participants
Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.
|
Invasive Cohort (Cohort 1) Usual Care
n=187 Participants
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 Participants
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Number of MACE
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 days from first testPopulation: The analysis population was defined as all subjects who were enrolled into the study. It is important to note that none of the adverse events reported throughout the study were related to FFRCT.
90 days (+30/-30 days) Major Adverse Coronary Event (MACE) rates, defined as: all cause death, non-fatal MI, unplanned hospitalization for acute coronary syndrome (ACS) leading to urgent revascularization and vascular complications (related to any coronary testing or procedure).This secondary endpoint compared the rates of MACE and vascular events across all subjects in Cohort 1 vs Cohort 2, Cohort 1A vs Cohort 2A and Cohort 1B vs Cohort 2B. The rates of MACE and vascular events were calculated by dividing the number of subjects with MACE and vascular events by the total number of subjects assigned to each analysis population.
Outcome measures
| Measure |
Planned Invasive Test Usual Care Strategy (Cohort 1B)
n=100 Participants
Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.
|
Planned Invasive Test FFRCT Guided Strategy (Cohort 2B)
n=104 Participants
Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.
|
Invasive Cohort (Cohort 1) Usual Care
n=187 Participants
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 Participants
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Number of MACE or Vascular Complications
|
0 Participants
|
1 Participants
|
2 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: 90 days from first testComparison of Resource utilization between cohort 1 and cohort 2 at 90 days (+/- 30 days): 1. Non-invasive diagnostic tests 2. Invasive diagnostic tests 3. Coronary revascularization procedures
Outcome measures
| Measure |
Planned Invasive Test Usual Care Strategy (Cohort 1B)
n=100 Participants
Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.
|
Planned Invasive Test FFRCT Guided Strategy (Cohort 2B)
n=104 Participants
Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.
|
Invasive Cohort (Cohort 1) Usual Care
n=187 Participants
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 Participants
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
Stress Echo
|
2 Participants
|
0 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
cCTA with FFRCT
|
0 Participants
|
17 Participants
|
0 Participants
|
64 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
ECG
|
2 Participants
|
3 Participants
|
59 Participants
|
32 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
Nuclear/Stress MPI/CMR
|
3 Participants
|
2 Participants
|
23 Participants
|
5 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
cCTA without FFRCT
|
8 Participants
|
2 Participants
|
21 Participants
|
12 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
IVUS, OCT, or FFR
|
3 Participants
|
7 Participants
|
17 Participants
|
30 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
ICA
|
12 Participants
|
19 Participants
|
187 Participants
|
76 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
PCI
|
3 Participants
|
9 Participants
|
42 Participants
|
45 Participants
|
|
Number of Participants With Resource (CV Test Types Performed) Utilization at 90 Days
CABG
|
2 Participants
|
1 Participants
|
17 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: at 90 daysPopulation: Values are the total number of patients who used particular medication (multiple medication types might be used per each patient)
Comparison of medication use between cohort 1A, 1B and cohort 2A, 2B at 90 days (+/- 15 days)
Outcome measures
| Measure |
Planned Invasive Test Usual Care Strategy (Cohort 1B)
n=100 Participants
Cohort 1B consisted of subjects who were referred for ICA and were evaluated and treated according to standard practice.
|
Planned Invasive Test FFRCT Guided Strategy (Cohort 2B)
n=104 Participants
Cohort 2B also consisted of subjects who were referred for ICA, but instead had cCTA imaging, and then at the investigators discretion had FFRCT analysis performed.
|
Invasive Cohort (Cohort 1) Usual Care
n=187 Participants
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 Participants
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Number of Participants With Medications Used by Type
Statin
|
24 participants (total count)
|
29 participants (total count)
|
83 participants (total count)
|
77 participants (total count)
|
|
Number of Participants With Medications Used by Type
Aspirin
|
29 participants (total count)
|
45 participants (total count)
|
115 participants (total count)
|
90 participants (total count)
|
Adverse Events
Non-invasive (Cohort 2) Usual Care
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
Non-invasive Cohort (Cohort 2) FFRCT
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Invasive Cohort (Cohort 1) Usual Care
Serious events: 6 serious events
Other events: 137 other events
Deaths: 1 deaths
Invasive Cohort (Cohort 1) FFRCT
Serious events: 9 serious events
Other events: 24 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Non-invasive (Cohort 2) Usual Care
n=100 participants at risk
(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly.
|
Non-invasive Cohort (Cohort 2) FFRCT
n=104 participants at risk
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
Invasive Cohort (Cohort 1) Usual Care
n=187 participants at risk
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 participants at risk
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Cardiac disorders
All-cause death
|
0.00%
0/100 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.00%
0/104 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.53%
1/187 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.00%
0/193 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
|
Cardiac disorders
Nonfatal MI
|
1.0%
1/100 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.00%
0/104 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.53%
1/187 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.52%
1/193 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
|
Cardiac disorders
Hospitalization with urgent revascularization
|
0.00%
0/100 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.00%
0/104 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.00%
0/187 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.52%
1/193 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
|
Cardiac disorders
MACE or vascular complications
|
1.0%
1/100 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
0.96%
1/104 • Number of events 1 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
2.1%
4/187 • Number of events 4 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
3.6%
7/193 • Number of events 7 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
Other adverse events
| Measure |
Non-invasive (Cohort 2) Usual Care
n=100 participants at risk
(Cohort 2) Subjects will be referred for non-invasive and/or invasive testing and evaluation. Prior to treatment of subjects considered for PCI and/or CABG, the investigator and the institution's heart team will review the results of all available diagnostic tests, including cCTA and FFRCT, and will recommend a treatment strategy accordingly.
|
Non-invasive Cohort (Cohort 2) FFRCT
n=104 participants at risk
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
Invasive Cohort (Cohort 1) Usual Care
n=187 participants at risk
(Cohort 1) of the study is an observational evaluation of resource utilization and outcomes based on standard practice for diagnosis and treatment of subjects with symptomatic suspected CAD and intermediate likelihood of obstructive CAD.
|
Invasive Cohort (Cohort 1) FFRCT
n=193 participants at risk
The second cohort of patients, enrolled after completion of the enrollment of the first cohort, was evaluated by CTA, with determination of FFRCT when a lesion of $30% stenosis was detected, or the patient was referred to invasive angiography.
|
|---|---|---|---|---|
|
Cardiac disorders
Invasive catheterization without obstructive CAD
|
6.0%
6/100 • Number of events 100 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
12.5%
13/104 • Number of events 104 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
73.3%
137/187 • Number of events 187 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
12.4%
24/193 • Number of events 193 • Clinical Outcomes at 1 Year
All AEs were submitted to the independent clinical events committee (CEC) for review and adjudication. CEC adjudicated all MACE events in a blinded fashion using standard, prospectively determined definitions as described in Protocol.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60