Patients enrolled in the PRECISE trial were randomised to either the “Usual Care” or “Precision Evaluation Strategy” arm


HeartFlow announces completion of patient enrollment in the PRECISE trial. (Credit: StockSnap from Pixabay)

HeartFlow, Inc., a leader in revolutionizing precision heartcare, today announced the completion of patient enrollment in the Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization (PRECISE) randomized controlled trial. Physicians from more than 50 hospitals around the world successfully enrolled 2,100 patients.

“With the PRECISE trial, we aim to demonstrate that a coronary-CTA led diagnostic pathway tailored to patient risk will offer greater precision in the diagnosis and management of patients with suspected CAD, while reducing the number, risks, and costs of unnecessary tests and procedures,” said Pamela Douglas, M.D., MACC, FASE, FAHA, the Ursula Geller Professor for Research in Cardiovascular Disease, Duke University School of Medicine and study chair of the PRECISE trial. “The pace of enrollment in the PRECISE trial was outstanding, despite the global pandemic, reinforcing that coronary artery disease remains one of the most important health issues we face as a society.”

The PRECISE trial 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).

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.

“We want to thank all of the patients, physicians, and research teams participating in the PRECISE trial for sharing our vision of advancing the scientific evidence for improving the diagnostic pathway for patients with CAD,” said Campbell Rogers, MD, FACC, Chief Medical Officer, HeartFlow. “HeartFlow is committed to providing the highest quality and most clinically relevant data to providers and patients, and we look forward to the results from the PRECISE trial being presented in the future.”