HeartFlow has completed enrollment for the PRECISE Trial.
The 2,100 patient trial, with centers all around the world, is designed to compare a “Usual Care” 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 coupled with the HeartFlow FFRct Analysis, when indicated.
The PRECISE trial will evaluate whether the new “Precision Evaluation Strategy” can improve the accuracy, outcomes, efficiency, and cost of diagnosing and caring for patients with suspected coronary artery disease (CAD).
The Redwood City, CA-based company said patients enrolled in the PRECISE trial were randomized to either the “Usual Care” or “Precision Evaluation Strategy” arm.
Patients in the “Precision Evaluation Strategy” arm were assessed using the PROMISE Minimal Risk Score and placed in either a low /no risk group or the intermediate /high risk group. Patients in the low/no risk group were treated with medications and lifestyle modifications but no immediate planned testing.
Patients in the intermediate /high risk group underwent a coronary CTA, and when additional information was needed, a HeartFlow FFRct Analysis was conducted. The primary endpoint of the PRECISE trial is the rate of major adverse cardiac events comprised of death, heart attack (myocardial infarction) or invasive coronary angiography without obstructive disease at 1 year.
The move comes on the heels of some other big news in the cardiovascular space - Elucid receiving $8 million to help commercialize its artificial intelligence software solution to detect cardiovascular disease.