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
REDWOOD CITY, Calif. - December 6, 2018 -
today announced the start of the
andomized Trial of the Optimal
vascularization (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 patients.”
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 tests
. 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.
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,
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Driessen, R. et al. PACIFIC FFRct Substudy. Presented at EuroPCR 2018.
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