PRECISE Demonstrates Accuracy of CCTA With HeartFlow’s FFRCT Analysis for Suspected CAD

November 6, 2022—HeartFlow, Inc. announced new trial results showing that evaluating patients with suspected coronary artery disease (CAD) by applying advanced artificial intelligence (AI) to coronary CTA (CCTA) allows for more accurate noninvasive diagnosis, reduces unnecessary testing, and offers higher confidence in identifying patients needing treatment.

The results from PRECISE were presented as late-breaking clinical data at the American Heart Association (AHA) Scientific Sessions 2022, held November 5-7 in Chicago, Illinois.

According to HeartFlow, PRECISE is a global randomized controlled trial enrolling 2,103 participants at 65 sites. The trial compared a noninvasive “Precision Pathway to Traditional Testing,” which includes stress testing or invasive cardiac catheterization. The Precision Pathway is consistent with the AHA/American College of Cardiology (ACC) guideline–recognized approach that defers testing for low-risk patients and tests all others with CCTA ± HeartFlow fractional flow reserve CT (FFRCT; ± indicates that FFRCT was used in those lesions that were 30%-90% stenosed).

The company noted that its FFRCT analysis uses AI coupled with highly trained analysts to create an interactive three-dimensional computer model of the heart that quantifies and displays blood flow and blockages.

The trial confirmed that the CCTA ± FFRCT–centered strategy, recognized by the AHA/ACC guidelines, is the superior diagnostic pathway for patients with suspected CAD.

HeartFlow stated that compared to traditional testing, the PRECISE trial showed that the Precision Pathway:

• Allows for more accurate noninvasive diagnosis, significantly lowering the rates of false negatives and false positives compared to traditional testing in patients with CAD
• Reduces unnecessary tests, providing a better patient experience, with a 4x reduction in unnecessary invasive catheterization and necessitating fewer initial diagnostic tests overall
• Provides confidence in treating the right patients and is 75% more likely to identify patients in need of intervention

The PRECISE study Chair is Pamela Douglas, MD, the Ursula Geller Professor for Research in Cardiovascular Disease at Duke University School of Medicine in Durham, North Carolina.

“This is the strongest level of scientific evidence yet to support the approach professional guidelines recommend that physicians use to diagnose stable chest pain patients,” commented Dr. Douglas in HeartFlow’s press release. “Combining multiple steps into a Precision Pathway provides a clear path forward for clinicians.”