Trial Outcomes & Findings for HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography (NCT NCT01757678)

Last Updated: 2017-11-14

Results Overview

The primary statistical measure will be the area under the receiver operating characteristic curve (AUC of ROC) of a patient-based model to detect hemodynamically significant obstruction. ROC graphs the change in sensitivity as the cut-point for positive/negative diagnosis moves from its lower to upper limit. FFR is used as the reference standard to determine the presence or absence of hemodynamic obstruction. For FFR, hemodynamically-significant obstruction of a coronary artery is defined as an FFR≤0.80 in any major epicardial coronary artery segment with diameter ≥2.0 mm during adenosine-mediated hyperemia. For cCTA, hemodynamically-significant obstruction of a coronary artery is defined as a stenosis \>50% . FFRCT will be calculated for each patient as the minimum FFRCT in any coronary artery segment . cCTA stenosis will be calculated for each patient as the highest cCTA stenosis category for any vessel all measurements will take place only in segments with diameter ≥2.0 mm.

Recruitment status

COMPLETED

Study phase

Target enrollment

276 participants

Primary outcome timeframe

1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.

Results posted on

2017-11-14

Participant Flow

Participant milestones

Participant milestones
Measure	Standard of Care: FFR and ICA Single arm Measured FFR: Fractional Flow Reserve
Overall Study STARTED	276
Overall Study COMPLETED	276
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

HeartFlowNXT - HeartFlow Analysis of Coronary Blood Flow Using Coronary CT Angiography

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard of Care: FFR and ICA n=276 Participants Single arm Measured FFR (Fractional Flow Reserve) and ICA (Invasive Coronary Angiography)
Age, Continuous	64 years STANDARD_DEVIATION 10 • n=93 Participants
Sex: Female, Male Female	101 Participants n=93 Participants
Sex: Female, Male Male	175 Participants n=93 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants
Race (NIH/OMB) Asian	91 Participants n=93 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants
Race (NIH/OMB) White	179 Participants n=93 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants
Race (NIH/OMB) Unknown or Not Reported	6 Participants n=93 Participants
Diabetes With Diabetes	62 participants n=93 Participants
Diabetes Without Diabetes	214 participants n=93 Participants
Hypertension With Hypertension	188 participants n=93 Participants
Hypertension Without Hypertension	88 participants n=93 Participants
Hyperlipidemia With Hyperlipidemia	214 participants n=93 Participants
Hyperlipidemia Without Hyperlipidemia	60 participants n=93 Participants
Hyperlipidemia Unknown Hiperlipidemia Status	2 participants n=93 Participants
Current smoker Current Smoker	50 participants n=93 Participants
Current smoker Former Smoker	106 participants n=93 Participants
Current smoker Never Smoked	118 participants n=93 Participants
Current smoker Unknown	2 participants n=93 Participants
Previous myocardial infarction Previous Myocardial Infarction	5 participants n=93 Participants
Previous myocardial infarction No Previous Myocardial Infarction	271 participants n=93 Participants
Body Mass Index, kg/m^2	26 kg/m^2 STANDARD_DEVIATION 4 • n=93 Participants
Creatinine, mg/dl	0.9 mg/dl STANDARD_DEVIATION .2 • n=93 Participants
Left ventricular ejection fraction, %	62 percent STANDARD_DEVIATION 7 • n=93 Participants

PRIMARY outcome

Timeframe: 1 day; Outcome measures were comparing FFRct to FFR. Incident time for FFR was dependent on the length of time on the cath procedure. FFRct was done remotely at HeartFlow's processing center in Redwood City with a turnaround time of 24 hours from CT scan.

Population: 22 of the 276 enrolled subjects were excluded by the FFR/QCA Core Lab, leaving an ITD population of 254 subjects. 3 additional subjects were excluded from the ITD analysis due to missing cCTA 30%-90% stenosis by coronary CTA.

Outcome measures

Outcome measures
Measure	FFRct vs. FFR n=251 Participants	cCTA vs. FFR n=251 Participants
AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-patient Basis	.90 probablility Interval 0.87 to 0.94	.81 probablility Interval 0.76 to 0.87

SECONDARY outcome

Timeframe: 1 day

Outcome measures

Outcome measures
Measure	FFRct vs. FFR n=484 Vessels	cCTA vs. FFR n=484 Vessels
AUC of FFRct Versus Coronary CTA for Demonstration of Ischemia (≤0.80) on a Per-vessel Basis	.93 probability Interval 0.91 to 0.95	.79 probability Interval 0.74 to 0.84

SECONDARY outcome

Population: 22 of the 276 enrolled subjects were excluded from the analysis by the FFR/QCA Core Lab.

Outcome measures

Outcome measures
Measure	FFRct vs. FFR n=254 Participants	cCTA vs. FFR
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Specificity: Coronary CTA Stenosis >50%	34 percentage of tests Interval 27.0 to 41.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Positive Predictive Value: ICA Stenosis >50%	63 percentage of tests Interval 52.0 to 73.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Positive Predictive Value: FFRct ≤ 0.80	65 percentage of tests Interval 56.0 to 74.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Positive Predictive Value: cCTA Stenosis >50%	40 percentage of tests Interval 33.0 to 47.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Negative Predictive Value: ICA Stenosis >50%	83 percentage of tests Interval 77.0 to 89.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Negative Predictive Value: FFRct ≤ 0.80	93 percentage of tests Interval 87.0 to 96.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Negative Predictive Value: cCTA Stenosis >50%	92 percentage of tests Interval 83.0 to 97.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Accuracy: ICA Stenosis >50%	77 percentage of tests Interval 71.0 to 82.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Accuracy: FFRct ≤ 0.80	81 percentage of tests Interval 76.0 to 85.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Accuracy: Coronary CTA Stenosis >50%	53 percentage of tests Interval 47.0 to 57.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Sensitivity: ICA Stenosis >50%	64 percentage of tests Interval 53.0 to 74.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Sensitivity: FFRct ≤ 0.80	86 percentage of tests Interval 77.0 to 92.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Sensitivity: Coronary CTA Stenosis >50%	94 percentage of tests Interval 86.0 to 97.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Specificity: ICA Stenosis >50%	83 percentage of tests Interval 77.0 to 88.0	—
Per-Patient Analysis: Diagnostic Performance of FFRct, Coronary CTA, and ICA Specificity: FFRct ≤ 0.80	79 percentage of tests Interval 72.0 to 84.0	—

SECONDARY outcome

Population: 22 of the 276 enrolled subjects were excluded from the analysis by the FFR/QCA Core Lab.

Outcome measures

Outcome measures
Measure	FFRct vs. FFR n=484 Vessels	cCTA vs. FFR
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Accuracy: ICA Stenosis >50%	82 percentage of tests Interval 79.0 to 86.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Accuracy: FFRct ≤ 0.80	86 percentage of tests Interval 83.0 to 89.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Accuracy: Coronary CTA Stenosis >50%	65 percentage of tests Interval 61.0 to 69.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Sensitivity: ICA Stenosis >50%	55 percentage of tests Interval 45.0 to 65.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Sensitivity: FFRct ≤ 0.80	84 percentage of tests Interval 75.0 to 89.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Sensitivity: Coronary CTA Stenosis >50%	83 percentage of tests Interval 74.0 to 89.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Specificity: ICA Stenosis >50%	90 percentage of tests Interval 86.0 to 93.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Specificity: FFRct ≤ 0.80	86 percentage of tests Interval 82.0 to 89.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Specificity: Coronary CTA Stenosis >50%	60 percentage of tests Interval 56.0 to 65.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Positive Predictive Value: ICA Stenosis >50%	58 percentage of tests Interval 48.0 to 68.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Positive Predictive Value: FFRct ≤ 0.80	61 percentage of tests Interval 53.0 to 69.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Positive Predictive Value: cCTA Stenosis >50%	33 percentage of tests Interval 27.0 to 39.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Negative Predictive Value: ICA Stenosis >50%	88 percentage of tests Interval 85.0 to 92.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Negative Predictive Value: FFRct ≤ 0.80	95 percentage of tests Interval 93.0 to 97.0	—
Per Vessel Diagnostic Performance of FFRct, Coronary CTA, and ICA Negative Predictive Value: cCTA Stenosis >50%	92 percentage of tests Interval 88.0 to 95.0	—

POST_HOC outcome

Population: Patients with intermediate stenosis severity (30%-70%) according to coronary CTA.

Outcome measures

Outcome measures
Measure	FFRct vs. FFR n=235 Participants	cCTA vs. FFR
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Specificity: Coronary CTA Stenosis > 50%	32 percentage of tests Interval 26.0 to 40.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Accuracy: FFRct ≤ 0.80	80 percentage of tests Interval 75.0 to 85.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Accuracy: Coronary CTA Stenosis > 50%	51 percentage of tests Interval 44.0 to 57.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Sensitivity: FFRct ≤ 0.80	85 percentage of tests Interval 74.0 to 91.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Sensitivity: Coronary CTA Stenosis >50%	93 percentage of tests Interval 85.0 to 97.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Specificity: FFRct ≤ 0.80	79 percentage of tests Interval 72.0 to 84.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Positive Predictive Value: FFRct ≤ 0.80	63 percentage of tests Interval 53.0 to 72.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Positive Predictive Value: cCTA Stenosis > 50%	37 percentage of tests Interval 31.0 to 44.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Negative Predictive Value: FFRct ≤ 0.80	92 percentage of tests Interval 87.0 to 96.0	—
Per-Patient Diagnostic Performance of FFRct in Patients With Intermediate Stenosis Severity (30%-70%) According to Coronary CTA Negative Predictive Value: cCTA Stenosis > 50%	91 percentage of tests Interval 81.0 to 96.0	—

Adverse Events

Standard of Care: ICA (Invasive Coronary Angiography)

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Standard of Care: cCTA (Coronary Computed Tomography Angio)

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Standard of Care: FFR (Fractional Flow Reserve)

Serious events: 5 serious events

Other events: 53 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Standard of Care: ICA (Invasive Coronary Angiography) n=276 participants at risk (ICA) Invasive coronary angiography in standard of care environment.	Standard of Care: cCTA (Coronary Computed Tomography Angio) n=276 participants at risk (cCTA) Coronary computed tomography angiography in standard of care environment.	Standard of Care: FFR (Fractional Flow Reserve) n=276 participants at risk (FFR) Fractional flow reserve in standard of care environment.
Injury, poisoning and procedural complications Coronary Dissection during invasive FFR measurement requiring percutaneous coronary intervention	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.
Injury, poisoning and procedural complications Transient cerebral ischemic attacks after ICA and invasive FFR measurement	0.72% 2/276 • Number of events 2 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.72% 2/276 • Number of events 2 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.72% 2/276 • Number of events 2 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.
Infections and infestations Fever	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.
Injury, poisoning and procedural complications Angina Pectoris	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.	0.36% 1/276 • Number of events 1 • Index Procedure through hospital discharge Note: this study involved prospective data collection to validate in a blinded manner a non-invasive test therefore adverse event information is reported based only on the standard of care index procedure.

Other adverse events

Additional Information

VP Clinical, Quality & Regulatory Affairs

HeartFlow

Phone: 650-241-1221

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60