HeartFlow Initiates PRECISE Randomized Clinical Trial

New trial of more than 2,000 patients will evaluate a
precision-testing pathway for coronary artery disease including
non-invasive coronary CTA + the HeartFlow Analysis as compared to the
conventional pathway for diagnosis

today announced the start of the Prospective
Randomized Trial of the Optimal Evaluation
of Cardiac Symptoms
and Revascularization (PRECISE) trial. The
first patient was enrolled by Michael C. Turner, M.D., at Imperial
Health Cardiovascular Specialists in Lake Charles, LA.

The PRECISE trial is designed to compare the usual approach of
diagnosing and evaluating patients with stable chest pain using a stress
test and/or invasive cardiac catheterization to a new Precision
Evaluation Strategy using risk-based testing and coronary computed
tomography angiography (CTA) scans. The PRECISE trial will evaluate
whether the new approach can improve the accuracy, outcomes, efficiency,
and cost of diagnosing and caring for patients with suspected coronary
artery disease (CAD). The trial will enroll more than 2,000 patients
from approximately 100 centers around the world.

“The impact of coronary artery disease is enormous. It remains the #1
cause of death worldwide. Yet, current testing options for suspected
heart disease are imperfect, leading to inaccurate diagnoses and the
need for additional, often invasive, testing,” said Pamela Douglas,
M.D., the Ursula Geller Professor for Research in Cardiovascular
Disease, Duke University School of Medicine and study chair of the
PRECISE trial. “With the PRECISE trial, we aim to help clinicians
diagnose patients with suspected CAD more efficiently by identifying
patients who can be managed medically versus those who require further
invasive assessment, while reducing the number, risks and costs of
unnecessary tests and procedures.”

In the PRECISE trial, patients will be randomized to either the Usual
Care or Precision Evaluation Strategy arm. Patients in the Precision
Evaluation Strategy arm will be assessed using the PROMISE Risk Score
and placed in either a low/no risk group or the intermediate/high risk
group. Patients in the low/no risk group will be treated with
medications and lifestyle modifications. All patients in the
intermediate/high risk group will undergo a CTA. When additional
information is needed, a HeartFlow FFRct Analysis will be conducted.

“The HeartFlow Analysis provides physicians with a more complete picture
and actionable information than any other non-invasive test, and can
play an important role in helping physicians diagnose patients with
suspected CAD,” said Campbell Rogers, M.D., Chief Medical Officer,
HeartFlow. “Our company is rooted in scientific evidence and the PRECISE
trial is the latest example of the company’s ongoing commitment to
bringing the very best clinically useful research to our physicians and

The HeartFlow Analysis is a non-invasive, personalized cardiac test that
applies artificial intelligence to image data taken from a standard CTA
scan to create a digital 3D model of the patient’s arteries. It then
applies advanced algorithms to solve millions of complex equations to
assess the impact any blockages have on blood flow to the heart. The
HeartFlow Analysis is provided via a secure online interface to offer
actionable information to enable clinicians to determine the optimal
course of treatment.

The HeartFlow Analysis has higher diagnostic performance, providing
better functional evaluation of CAD, than other non-invasive tests1.
The HeartFlow technology has been demonstrated to reduce unnecessary
invasive diagnostic coronary angiography procedures, which can be
associated with bleeding, stroke, major blood vessel damage and other
serious complications. It also significantly reduces healthcare costs
for hospitals.2

To date, clinicians around the world have used the HeartFlow Analysis
for more than 25,000 patients to aid in the diagnosis of heart disease.

About HeartFlow, Inc.

HeartFlow, Inc. is a medical technology company redefining the way heart
disease is diagnosed and treated. Our non-invasive HeartFlow FFRct
Analysis leverages deep learning to create a personalized 3D model of
the heart. By using this model, clinicians can better evaluate the
impact a blockage has on blood flow and determine the best treatment for
patients. Our technology is reflective of our Silicon Valley roots and
incorporates decades of scientific evidence with the latest advances in
artificial intelligence. The HeartFlow FFRct Analysis is commercially
available in the United States, Canada, Europe and Japan. For more
information, visit www.heartflow.com.

1 Driessen, R. et al. PACIFIC FFRct Substudy. Presented at
EuroPCR 2018.

2 Douglas PS, DeBruyne B, Pontone G., Patel MR, et al.
One-year outcomes of FFRCT-guided care in patients with suspected
coronary disease: The PLATFORM Study. J Am Coll Cardiol.


Jennie Kim


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