FFRCT RIPCORD Study: Availability of HeartFlow FFRCT Analysis Changes the Management of
Patients with Coronary Artery Disease
PARIS — May 19, 2015 — Adding the HeartFlow® FFRCT Analysis to a standard coronary CT
angiogram (cCTA) may change the course of treatment in more than one third of patients with
coronary artery disease, according to a study presented today at the EuroPCR 2015 conference.
Results of the FFRCT RIPCORD study, presented by Prof. Nick Curzen of the University Hospital
Southampton, United Kingdom, further reinforces the ability of the HeartFlow Analysis to aid in
patient management.
The HeartFlow Analysis is the first and only non-invasive imaging technology for coronary artery
disease to offer physicians insight on both the extent of any arterial blockage, as well as whether it
is impacting blood flow, two vital pieces of information physicians need to develop a treatment
plan that is right for a patient. Using standard cCTA images, HeartFlow’s technology solves
millions of complex equations simulating blood flow in the coronary arteries to provide
mathematically computed fractional flow reserve (FFRCT) values.
In the study, three experienced cardiologists reviewed cCTAs of 200 consecutive cases of patients
with stable chest pain. The physicians agreed upon a plan to manage each patient: optimal
medical therapy, a percutaneous coronary intervention (PCI) such as a stent, or coronary bypass
surgery. In some cases, the physicians agreed that they were unable to make a decision and
needed more information, such as an invasive diagnostic angiogram with associated invasive
fractional flow reserve (FFR).
Next, the physicians were shown the results of the HeartFlow FFRCT Analysis for each case and
made a second management decision incorporating these data. Adding the HeartFlow Analysis
changed the decision to medical therapy in 26 of the 87 cases (30 percent) that were originally
recommended for a PCI. Of cases originally recommended for medical therapy, 7 of 67 (9 percent)
were changed to PCI and one was changed to bypass surgery. Without the HeartFlow Analysis, the
physicians needed more information in 38 cases (19 percent), but with the HeartFlow Analysis,
there were no cases in which the physicians needed additional information.
Overall, the management plan was changed in 72 of the 200 patients (36 percent). In 16 of the 87
cases considered candidates for PCI based on the angiogram (18 percent), one or more of the
target lesions was changed using the FFRCT Analysis.
“It is well established that invasive FFR can refine management decisions based solely upon the
angiogram for patients with chest pain,” said Prof. Curzen. “This study demonstrates that the non-
invasive HeartFlow FFRCT Analysis has the potential to become the default method for the initial
assessment of many patients with cardiac-sounding chest pain by assessing both the coronary
anatomy and physiology simultaneously. This could have important implications for our clinical
practice and would challenge conventional care pathways.”
Invasive fractional flow reserve (FFR) is seen as the gold standard in diagnosing functionally
significant coronary artery disease. In patients with multi-vessel disease, an FFR-directed PCI
strategy is associated with better clinical outcomes compared to angiography-directed PCI (FAME;
CCM-100-068-A
FAME 2).1,2 The FFRCT RIPCORD study was modeled after the original RIPCORD study, in which
invasive FFR altered the course of patient management in 26 percent of cases when compared to
angiographic assessment alone.3
“Three major studies validating the HeartFlow FFRCT Analysis have established that it has an
unmatched level of accuracy in determining, non-invasively, whether a lesion is restricting blood
flow to the heart,” said John H. Stevens, M.D., chairman and CEO of HeartFlow. “The FFRCT
RIPCORD study demonstrates the profound impact that this technology can have in directing
patient care.”
About HeartFlow
HeartFlow Inc. is a personalized medical technology company dedicated to transforming the way
cardiovascular disease is managed. Committed to improving outcomes, reducing costs and
creating a better patient experience, HeartFlow’s goal is to provide healthcare professionals with
actionable knowledge about each patient by combining best-in-class, non-invasive healthcare
imaging with advanced, computational fluid dynamics technology and the insights of big data. Its
non-invasive HeartFlow FFRCT Analysis helps physicians diagnose coronary artery disease and
provides them with information they need to manage each patient. The HeartFlow Analysis
received de novo clearance from the United States Food and Drug Administration in November
2014. For more information, visit www.heartflow.com.
1 Tonino et al., NEJM 2009, 360:213
2 De Bruyne et al., NEJM 2012, 367:991
3 Curzen et al., Circ Cardiovasc Interv. 2014, 248-255
Media Contact:
Diana Soltesz
Nobles Global Communications
818-618-5634
CCM-100-068-A