Improving Clinical Decision Making

Aids Physicians During the Diagnostic Decision-Making Process

Results from the PLATFORM trial planned invasive angiogram cohort:

Greatly reduced unnecessary invasive angiography 1

61%
of angiograms were
deferred
83%
reduction in unnecessary
angiograms

Effectively helps direct patients to the most appropriate care 1

Balance scales
The number of
revascularizations
was similar
0
Zero adverse clinical events
among patients whose
angiogram was deferred

PLATFORM Trial: Planned Invasive Angiogram Cohort

Diagram showing the study design/outcome ratios for the PLATFORM trial
Usual Care Path
Invasive
Angiogram
CAD
No significant CAD
Necessary Invasive
Angiography
Unnecessary
Invasive Angiography
Revascularization
HeartFlow-Guided Care Path
Non-Invasive
HeartFlow-Guided
Strategy
No Significant
CAD
Invasive
Angiography
Deferred
Invasive
Angiogram
CAD
No significant CAD
Necessary Invasive
Angiography
Unnecessary
Invasive Angiography
Revascularization

Learn more about the PLATFORM trial

Design

The PLATFORM (Prospective LongitudinAl Trial of FFR CT: Outcome and Resource IMpacts) trial was designed to assess whether patients with suspected coronary artery disease (CAD) evaluated using a HeartFlow-guided strategy would undergo fewer invasive coronary angiograms that showed no significant CAD as compared to patients evaluated based on standard practice.

  • Prospective, controlled, pragmatic comparative effectiveness trial utilizing a consecutive cohort design.
  • Patients all had suspected CAD (pre-test likelihood of 20-80%) and presented in two groups based on the intended evaluation plan before enrollment: planned invasive coronary angiogram and planned non-invasive test.
  • Half of PLATFORM patients underwent usual care and half were evaluated using a HeartFlow-guided strategy. Additional care decisions were made by the sites and were not dictated by the protocol.

Enrollment

584 patients were enrolled at 11 centers in Europe.

Diagram showing the numbers of patients in each group for the PLATFORM Trial

Results

For patients with a planned invasive angiogram, a HeartFlow-guided strategy:

  • Appropriately helped identify patients who could benefit from revascularization, and thereby greatly reduced unnecessary invasive testing.
  • 61% of invasive angiograms were deferred.
  • Angiograms showing no significant CAD were reduced by 83%.
  • The number of patients who underwent a revascularization (e.g., stent procedure or coronary artery bypass graft (CABG) surgery) was similar to that found in the Usual Care group.
  • During the follow-up period of one year, no adverse clinical events occurred in any patient whose angiogram was canceled based on the findings from a HeartFlow-guided strategy.

Conclusion

Incorporating a HeartFlow-guided strategy was associated with a significantly lower rate of invasive angiograms showing no significant CAD.

Sources: Douglas, et al. Eur Heart J. 2015., Douglas, et al. Presented at ACC 2016.

1. Douglas, et al. Eur Heart J. 2015.

Reducing the Cost of Care

Provides Significant Savings to the Healthcare System 2

Downwards arrow with dollar sign; cost reduction A HeartFlow-guided strategy reduced the overall costs to the healthcare system by more than $4,000 per patient after one year. The mean one-year per-patient cost for the usual care strategy was $12,145 compared to the $8,127 cost for the HeartFlow-guided strategy. When including the $1,500 cost of the HeartFlow Analysis, the cost reduction is 26 percent.

Learn more about the PLATFORM trial

Design

The PLATFORM (Prospective LongitudinAl Trial of FFR CT: Outcome and Resource IMpacts) trial was designed to assess whether patients with suspected coronary artery disease (CAD) evaluated using a HeartFlow-guided strategy would undergo fewer invasive coronary angiograms that showed no significant CAD as compared to patients evaluated based on standard practice.

  • Prospective, controlled, pragmatic comparative effectiveness trial utilizing a consecutive cohort design.
  • Patients all had suspected CAD (pre-test likelihood of 20-80%) and presented in two groups based on the intended evaluation plan before enrollment: planned invasive coronary angiogram and planned non-invasive test.
  • Half of PLATFORM patients underwent usual care and half were evaluated using a HeartFlow-guided strategy. Additional care decisions were made by the sites and were not dictated by the protocol.

Enrollment

584 patients were enrolled at 11 centers in Europe.

Diagram showing the numbers of patients in each group for the PLATFORM Trial

Results

For patients with a planned invasive angiogram, a HeartFlow-guided strategy:

  • Appropriately helped identify patients who could benefit from revascularization, and thereby greatly reduced unnecessary invasive testing.
  • 61% of invasive angiograms were deferred.
  • Angiograms showing no significant CAD were reduced by 83%.
  • The number of patients who underwent a revascularization (e.g., stent procedure or coronary artery bypass graft (CABG) surgery) was similar to that found in the Usual Care group.
  • During the follow-up period of one year, no adverse clinical events occurred in any patient whose angiogram was canceled based on the findings from a HeartFlow-guided strategy.

Conclusion

Incorporating a HeartFlow-guided strategy was associated with a significantly lower rate of invasive angiograms showing no significant CAD.

Sources: Douglas, et al. Eur Heart J. 2015., Douglas, et al. Presented at ACC 2016.

2. Douglas, et al. Presented at ACC 2016.

Improving Patient Quality of Life

Provides a Better Patient Experience 3

Outline of a person with their arms in the airPatients in the HeartFlow-guided arm of the PLATFORM trial experienced an improvement in quality of life from baseline to 90-day follow-up.

Among patients with a planned non-invasive test, improvements in quality of life were greater for patients undergoing a HeartFlow-guided strategy than patients undergoing usual care.

Learn more about the PLATFORM trial

Design

The PLATFORM (Prospective LongitudinAl Trial of FFR CT: Outcome and Resource IMpacts) trial was designed to assess whether patients with suspected coronary artery disease (CAD) evaluated using a HeartFlow-guided strategy would undergo fewer invasive coronary angiograms that showed no significant CAD as compared to patients evaluated based on standard practice.

  • Prospective, controlled, pragmatic comparative effectiveness trial utilizing a consecutive cohort design.
  • Patients all had suspected CAD (pre-test likelihood of 20-80%) and presented in two groups based on the intended evaluation plan before enrollment: planned invasive coronary angiogram and planned non-invasive test.
  • Half of PLATFORM patients underwent usual care and half were evaluated using a HeartFlow-guided strategy. Additional care decisions were made by the sites and were not dictated by the protocol.

Enrollment

584 patients were enrolled at 11 centers in Europe.

Diagram showing the numbers of patients in each group for the PLATFORM Trial

Results

For patients with a planned invasive angiogram, a HeartFlow-guided strategy:

  • Appropriately helped identify patients who could benefit from revascularization, and thereby greatly reduced unnecessary invasive testing.
  • 61% of invasive angiograms were deferred.
  • Angiograms showing no significant CAD were reduced by 83%.
  • The number of patients who underwent a revascularization (e.g., stent procedure or coronary artery bypass graft (CABG) surgery) was similar to that found in the Usual Care group.
  • During the follow-up period of one year, no adverse clinical events occurred in any patient whose angiogram was canceled based on the findings from a HeartFlow-guided strategy.

Conclusion

Incorporating a HeartFlow-guided strategy was associated with a significantly lower rate of invasive angiograms showing no significant CAD.

Sources: Douglas, et al. Eur Heart J. 2015., Douglas, et al. Presented at ACC 2016.

3. Hlatky, et al. J Am Coll Cardiol. 2015.

Additional Evidence

Demonstrating the Clinical Impact of The HeartFlow Analysis

Additional studies show the HeartFlow Analysis
reduces uncertainty in treatment planning.

Learn more about the FFR CT
RIPCORD study

Learn more about the PROMISE
FFR CT study

Design

Three cardiologists reviewed CT scans from 200 consecutive patients with suspected coronary artery disease (CAD) and agreed upon a plan to manage each patient:

  • optimal medical therapy,
  • revascularization (e.g., stent procedure or coronary artery bypass graft (CABG) surgery), or
  • additional testing to gather more information.

The cardiologists were then shown the results of the HeartFlow Analysis for each case and made a second management decision.

Results

Diagram showing a breakdown of results of the FFRCT RIPCORD study

  • 88 cases (44%) had management decisions modified based on the information from the HeartFlow Analysis.
    • 72 cases (36%) were moved from one treatment pathway to another (i.e. reassigned from the originally planned optimal medical therapy group to the revascularization group).
    • 16 cases (8%) recommended for revascularization both before and after the HeartFlow Analysis had the target vessel for treatment changed.
  • With CT scan data alone, cardiologists needed more information in 38 cases (19%) to determine a management plan, and by adding the HeartFlow Analysis cardiologists needed additional information in zero (0%) cases.

Conclusion

Incorporating a HeartFlow-guided strategy may change the course of treatment for patients with suspected coronary artery disease.

Source: Curzen, et al. EuroPCR 2015.

PROMISE FFR CT Study

PROMISE FFR CT is a sub-study of the PROMISE (PROspective Multicenter Imaging Study for Evaluation of chest pain) trial and provides insight into how the HeartFlow Analysis can effectively serve as a frontline test for patients with suspected coronary artery disease (CAD).

PROMISE FFR CT demonstrates the effectiveness of a HeartFlow-guided strategy:

Fewer patients would have undergone an unnecessary invasive angiogram. *

Non-invasive testing modalities and associated rate of angiograms showing no significant CAD.

Bar graph showing the scale of reduction of unnecessary angiograms that a HeartFlow-guided strategy provided in the PROMISE FFRCT sub-study, compared to CT Scan or Functional Testing

A HeartFlow-guided strategy may have reduced unnecessary angiograms by almost 80%, compared to functional testing (11% vs. 52%).

Many patients would have had their invasive angiogram deferred.

Nearly 30% of invasive angiograms would have been avoided if a HeartFlow-guided strategy had been available. This may have reduced the rate of invasive angiograms in the anatomical testing (CT) arm of PROMISE from 12.1% to 8.8% (compared to the rate of 8.1% measured in the functional testing arm).

Patients who would have had an invasive angiogram deferred would have had a very low adverse event rate.

Of the patients whose angiogram would have been deferred based on a HeartFlow-guided strategy, only two had events. Both patients had no CAD on invasive angiography and would not have been identified in either frontline diagnostic strategy.

Patients in need of revascularization (e.g., stent or coronary artery bypass graft) would have been effectively identified.

Over 90% of patients who underwent a revascularization were identified by the HeartFlow Analysis as having significant CAD.

The researchers concluded the HeartFlow Analysis “better predicted revascularization and events” compared to relying on CT scans alone.

*”Unnecessary invasive angiogram” is defined as an invasive angiogram that finds no significant CAD.

Sources: Michael Lu, et al. Presented at TCT 2015., Douglas, et al. N Engl J Med. 2015.

The HeartFlow Analysis is Built on a
FOUNDATION OF CLINICAL RESEARCH

3
Clinical Validation
Studies

In prospective, multicenter clinical studies enrolling more than 600 patients, the HeartFlow Analysis demonstrated high diagnostic accuracy in the diagnosis of coronary artery disease.

Using invasive FFR as the reference standard

What is FFR?

What is FFR?

Fractional Flow Reserve (FFR) is the most accurate and reliable measure for determining a lesion’s impact on blood flow to the heart and is now considered to be the standard of care for guiding percutaneous coronary revascularization in guidelines by the European Society of Cardiology 8 and the American College of Cardiology. 9

FFR is measured at the time of invasive coronary angiography. A pressure sensing wire is introduced into the coronary arteries, medications are introduced to simulate maximal coronary blood flow and then the wire directly measures pressure before and after a coronary stenosis. This data is used to determine the FFR value which can help a clinician to understand whether a coronary lesion is obstructing blood flow to a patient’s heart.

What is FFR CT?

FFR CT is a non-invasive method to provide clinicians with information on whether or not a coronary lesion is obstructing blood flow without the need to perform an invasive FFR measurement. Using a standard CT scan of the heart and physiologic simulations of blood flow, the HeartFlow FFR CT Analysis mathematically assesses how a coronary artery narrowing may be impacting blood flow to the heart.

Venn Diagram showing FFRCT sitting in the overlap between Non-Invasive testing, i.e. CT Scan, and Assessment of Lesion-Specific Impact on Blood Flow, i.e., FFR

Table
HeartFlowNXT
Study10
DEFACTO
Study11
DISCOVER-FLOW
Study12
Objectives
Determine diagnostic performance of non-invasive FFRCT
in patients with suspected CAD
Design
Prospective, multicenter, core-lab controlled study
Methods
484 vessels in 254 patients
undergoing CT scan, invasive
angiography, FFR,
and FFRCT.
407 vessels in 252 patients
undergoing CT scan, invasive
angiography, FFR,
and FFRCT.
159 vessels in 103 patients
undergoing CT scan, invasive
angiography, FFR,
and FFRCT.
Key Results
FFRCT provides high diagnostic
accuracy and discrimination of
hemodynamically significant
CAD, with per-vessel sensitivity
of 84% and specificity of 86%.
FFRCT was associated with
improved diagnostic accuracy
and discimination of ischemia
versus a CT scan alone.
FFRCT demonstrated high
diganostic accuracy for the
detection and exclusion of
coronary lesions that cause
ischemia, with per-vessel
sensitivity of 88% and
specificity of 82%.

8. Eur Heart J. 2013;34(38):2949-3003. doi: 10.1093/eurheartj/eht296.

9. J Am Coll Cardiol. 2011;58(24):e44-e122. doi:10.1016/j.jacc.2011.08.007.

10. Nørgaard, et al. J Am Coll Cardiol. 2014.

11. Min, et al. JAMA. 2012.

12. Koo, et al. J Am Coll Cardiol. 2011.