Trial Outcomes & Findings for The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (NCT NCT03702244)

Last Updated: 2023-12-29

Results Overview

The centrally adjudicated (by Clinical Events Committee) primary end point was a composite of clinical efficiency as a gatekeeper to invasive testing (catheterization without obstructive CAD) and safety (death, non fatal myocardial infarction \[MI\]) at 1 year. Invasive cardiac catheterization without obstructive coronary artery disease defined as the absence of any ≥50% stenosis or hemodynamic indication of significance (no FFR ≤0.80 or iFR≤0.89) in any major epicardial vessel including side branches ≥2 mm in diameter, as determined by core-lab adjudicated quantitative coronary angiography (QCA) or if QCA not performed, by site report. A detailed description and information on the definitions of primary endpoint component definitions is provided in the current version of the study Protocol, Statistical Analysis Plan, and the published trial design article.

Recruitment status

COMPLETED

Study phase

Target enrollment

2103 participants

Primary outcome timeframe

1 year

Results posted on

2023-12-29

Participant Flow

Participants were randomly assigned 1:1 to precision strategy (PS) or usual testing (UT), stratified by site, intended first test if randomly assigned to UT, and minimal vs moderate-high risk using the validated PROMISE minimal risk score(PMRS). All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.

Participant milestones

Participant milestones
Measure	Precision Strategy (PS) Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Overall Study STARTED	1057	1046
Overall Study COMPLETED	1057	1046
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The PRECISE Protocol: Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Precision Strategy (PS) n=1057 Participants Participants were randomly assigned 1:1 to precision strategy (PS) or usual testing (UT), stratified by site, intended first test if randomly assigned to UT, and minimal vs moderate-high risk using the validated PROMISE minimal risk score(PMRS). Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 Participants Participants were randomly assigned 1:1 to precision strategy (PS) or usual testing (UT), stratified by site, intended first test if randomly assigned to UT, and minimal vs moderate-high risk using the validated PROMISE minimal risk score(PMRS). Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Total n=2103 Participants Total of all reporting groups
Age, Continuous	58.0 years STANDARD_DEVIATION 11.5 • n=5 Participants	58.9 years STANDARD_DEVIATION 11.6 • n=7 Participants	58.4 years STANDARD_DEVIATION 11.5 • n=5 Participants
Sex: Female, Male Female	508 Participants n=5 Participants	539 Participants n=7 Participants	1047 Participants n=5 Participants
Sex: Female, Male Male	549 Participants n=5 Participants	507 Participants n=7 Participants	1056 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Asian	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Black or African American	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) White	892 Participants n=5 Participants	875 Participants n=7 Participants	1767 Participants n=5 Participants
Race (NIH/OMB) More than one race	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	NA Participants n=5 Participants	NA Participants n=7 Participants	NA Participants n=5 Participants
Hypertension	642 Participants n=5 Participants	606 Participants n=7 Participants	1248 Participants n=5 Participants
Body mass index	30.2 kg/m^2 STANDARD_DEVIATION 6.6 • n=5 Participants	29.9 kg/m^2 STANDARD_DEVIATION 6.2 • n=7 Participants	30.0 kg/m^2 STANDARD_DEVIATION 6.4 • n=5 Participants
Diabetes	176 Participants n=5 Participants	197 Participants n=7 Participants	373 Participants n=5 Participants
Dyslipidemia	668 Participants n=5 Participants	681 Participants n=7 Participants	1349 Participants n=5 Participants
Family history of premature CAD	404 Participants n=5 Participants	395 Participants n=7 Participants	799 Participants n=5 Participants
Peripheral arterial or cerebrovascular disease	65 Participants n=5 Participants	56 Participants n=7 Participants	121 Participants n=5 Participants
Current or past tobacco use	544 Participants n=5 Participants	554 Participants n=7 Participants	1098 Participants n=5 Participants
Absence of any CV risk factors	67 Participants n=5 Participants	61 Participants n=7 Participants	128 Participants n=5 Participants
PROMISE minimal risk score >0.46 (minimal risk)	214 Participants n=5 Participants	219 Participants n=7 Participants	433 Participants n=5 Participants
Primary presenting symptom (Chest pain)	870 Participants n=5 Participants	876 Participants n=7 Participants	1746 Participants n=5 Participants
Type of angina (Typical - cardiac)	249 Participants n=5 Participants	257 Participants n=7 Participants	506 Participants n=5 Participants
Type of angina (Atypical - possible cardiac)	600 Participants n=5 Participants	597 Participants n=7 Participants	1197 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 year

Population: Statistical testing for recurrent events was performed using the negative binomial methods for recurrent events. The primary endpoint of this study is estimated as time to first occurrence of any of its three following components: All-cause death; Non-fatal MI; Invasive cardiac catheterization without obstructive CAD.

Outcome measures

Outcome measures
Measure	Precision Strategy (PS) n=1057 Participants Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 Participants Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease Death or Nonfatal Myocardial Infarction (first event only)	18 number of events	12 number of events
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease Death from any cause	5 number of events	7 number of events
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease Nonfatal Myocardial Infarction	13 number of events	5 number of events
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease Invasive cardiac catheterization without Obstructive coronary disease	27 number of events	107 number of events
Primary Composite (Number) of Deaths / MIs / Invasive Coronary Angiography Without Obstructive Disease Primary Composite End Point	44 number of events	118 number of events

SECONDARY outcome

Timeframe: 1 year

Population: For All Cause Hospitalization only a descriptive summary will be presented.

Urgent and unscheduled hospitalizations for cardiovascular causes include hospitalization for ischemic heart disease including myocardial infarction and unstable angina, cerebrovascular disease including stroke and TIA, heart failure, acute and/or critical limb ischemia, other thrombotic events including pulmonary embolism, arrhythmias, cardiac arrest and other clear cardiovascular causes for hospitalization that do not meet the criteria for the specific events listed here (e.g., hospitalization for acute cardiac chest pain that does not meet the criteria for MI or UA).

Outcome measures

Outcome measures
Measure	Precision Strategy (PS) n=1057 Participants Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 Participants Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Number of Unplanned Hospitalizations (Including Admissions With Death or MI) Cardiovascular	31 number of events	21 number of events
Number of Unplanned Hospitalizations (Including Admissions With Death or MI) For Unstable Angina	9 number of events	5 number of events

SECONDARY outcome

Timeframe: 1 year

Population: Additionally catheterization efficiency or cath yield is defined as the proportion of participants with an invasive coronary angiogram who underwent revascularization within 6 months of catheterization. Rates will be summarized by 2 groups.

Catheterization efficiency was defined as the proportion of invasive cardiac catheterization patients who undergo revascularization (PCI or CABG) within 6 months. Revascularization may occur either percutaneously (PCI) or surgically (CABG) or as hybrid (PCI and CABG). For PCI, any intervention on a lesion in the coronary tree (including angioplasty, stenting, intravascular lithotripsy) whether successful or not will be considered a revascularization. For CABG the start of the surgical procedure (skin incision) was considered as CABG, whether the procedure was successful or not. Staged revascularization was considered as one revascularization event.

Outcome measures

Outcome measures
Measure	Precision Strategy (PS) n=1057 Participants Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 Participants Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Number of Catheterization and Revascularization Procedures Total Revascularizations	97 number of events	54 number of events
Number of Catheterization and Revascularization Procedures PCI	77 number of events	37 number of events
Number of Catheterization and Revascularization Procedures Invasive catheterization	135 number of events	177 number of events
Number of Catheterization and Revascularization Procedures Rate of finding obstructive CAD on catheterization	108 number of events	70 number of events
Number of Catheterization and Revascularization Procedures CABG	21 number of events	18 number of events

SECONDARY outcome

Timeframe: 1 Year

Population: The number (%) will be summarized between the precision care arm and usual care arm.

Lipid-lowering agents included statins, ezetimibe, PCSK9 inhibitors. Antiplatelet agents included aspirin, clopidogrel, ticagrelor, or prasugrel. Antihypertensive medications included calcium channel blockers, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, angiotensin-neprilysin inhibitor, beta blockers, nitrates, or diuretics.

Outcome measures

Outcome measures
Measure	Precision Strategy (PS) n=900 Participants Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=873 Participants Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Number of Participants With Preventive Medication Use Antiplatelet	321 Participants	237 Participants
Number of Participants With Preventive Medication Use Lipid-lowering	450 Participants	365 Participants
Number of Participants With Preventive Medication Use Anti-hypertensive	504 Participants	455 Participants

SECONDARY outcome

Timeframe: 1 year

Population: Angina Frequency Score at Baseline was used as reference. Not all participants fully completed the questionnaire, therefore data were collected as presented below.

Overall health status was assessed briefly using the EQ-5D-5L, a standardized generic measure that can also be used to link specific health states to general population-based utilities. The EQ-5D-5L consists of two parts: (1) a descriptive assessment of five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression), each of which can take one of five responses corresponding to the level of severity within each dimension, and (2) a self-rating 0- 100 "thermometer" of current health-related quality of life. The proportion of participants with frequent angina (Seattle Angina Questionnaire angina frequency score \<80).

Outcome measures

Outcome measures
Measure	Precision Strategy (PS) n=894 Participants Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=868 Participants Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Number of Participants With Quality of Life (Angina Frequency) Assessment More frequent angina: all participants	141 Participants	140 Participants
Number of Participants With Quality of Life (Angina Frequency) Assessment More frequent angina: participants with typical angina	50 Participants	40 Participants

SECONDARY outcome

Timeframe: 1 year

Population: In instances in which sufficient information required to assess actual dose is not available, data were imputed. For CCTA and nuclear imaging missing values were imputed based on distribution of data from participants. Cumulative radiation exposure from additional cardiac testing and procedures during the entire follow-up period were also collected or estimated based on accepted average exposures. Given high missingness in catheterization data, a fixed estimate of 6.6 mSv and 4.1 mSv was used.

The cumulative radiation exposure over the 12 months following Randomization was calculated based on each participant's exposure to radiation for cardiovascular care. If data are missing in \> 80% or more of the diagnostic and procedural testing, a single fixed estimate of radiation based on the literature will be used to impute. Given high missingness in catheterization data, a fixed estimate of 6.6 mSv and 4.1 mSv was used for catheterization with and without revascularization, respectively, based on recent trial data.

Outcome measures

Outcome measures
Measure	Precision Strategy (PS) n=1057 Participants Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 Participants Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Cumulative Radiation Exposure From All Cardiovascular Procedures (12 M), MilliSievert (mSv)	5.2 mSv Standard Deviation 5.4	4.7 mSv Standard Deviation 6.0

Adverse Events

Precision Strategy (PS)

Serious events: 40 serious events

Other events: 13 other events

Deaths: 5 deaths

Usual Testing (UT)

Serious events: 30 serious events

Other events: 43 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Precision Strategy (PS) n=1057 participants at risk Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 participants at risk Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Cardiac disorders Myocardial Infarction (MI - non-fatal)	1.2% 13/1057 • Number of events 13 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).	0.48% 5/1046 • Number of events 5 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).
Cardiac disorders Death from any cause	0.47% 5/1057 • Number of events 5 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).	0.67% 7/1046 • Number of events 7 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).
Cardiac disorders Unplanned CV hospitalization excluding admissions with MI or death	2.1% 22/1057 • Number of events 23 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).	1.7% 18/1046 • Number of events 18 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).

Other adverse events

Other adverse events
Measure	Precision Strategy (PS) n=1057 participants at risk Participants in the PS group with a PROMISE minimal risk score (PMRS - validated tool) threshold value of greater than 0.46 were assigned to deferred testing. All other participants in the PS group (ie, those with a PMRS \<0.46), or those with known atherosclerosis such as vascular calcification on chest CT, received cCTA with selective FFR-CT for site-read 30% to 90% stenoses. All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.	Usual Testing (UT) n=1046 participants at risk Among participants in the UT group, site clinicians chose the initial testing modality, including exercise electrocardiogram, stress echocardiogram, stress nuclear myocardial perfusion imaging (single-photon emission CT or positron emission tomography), stress cardiovascular magnetic resonance imaging, or catheterization. All PS and UT testing was performed according to local protocols, and all subsequent testing and care decisions were made locally.
Product Issues HeartFlow Analysis (FFRCT) - Customer Support Investigations	0.00% 0/1057 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).	0.00% 0/1046 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).
Injury, poisoning and procedural complications Major test and procedural complications by test type	0.38% 4/1057 • Number of events 4 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).	0.57% 6/1046 • Number of events 6 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).
Injury, poisoning and procedural complications Minor test and procedural complications by test type	0.85% 9/1057 • Number of events 9 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).	3.5% 37/1046 • Number of events 37 • 1 year Since all trial procedures represent standard of care for the eligible study population, there are no specific safety events associated with investigative procedures in this trial. However, there are known complications from these clinically recommended tests and procedures which are outlined in sections below. An independent clinical event committee (CEC) was responsible for the blinded review and adjudication of the primary endpoints (Death, MI and Cath without obstructive CAD).

Additional Information

Director, Clinical Operations

Heartflow Inc

Phone: 877-478-3569

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Confidentiality embargo was in place until primary results were published.
Publication restrictions are in place

Restriction type: OTHER