March 16, 2019
ADVANCE Study Supports HeartFlow Analysis to Identify Lower-Risk Patients
March 17, 2019—HeartFlow, Inc. announced that results from the ADVANCE trial of the HeartFlow fractional flow reserve computed tomography (FFRct) analysis technology were presented at the ACC's 68th Annual Scientific Session, being held March 16–18 in New Orleans, Louisiana. The study was simultaneously published online by Manesh Patel, MD, et al in Journal of the American College of Cardiology: Cardiovascular Imaging.
The company stated that the study confirms that the HeartFlow FFRct analysis enables physicians to efficiently identify which patients have a low risk of adverse cardiovascular events, despite symptoms suggestive of coronary artery disease, and can safely avoid invasive testing out to 1 year.
The HeartFlow analysis technology starts with a standard coronary CTA to create a digital, personalized, three-dimensional model of the heart and provides FFRct values along the coronary arteries. The HeartFlow FFRct analysis is commercially available in the United States, Canada, Europe, and Japan.
In the study, investigators used FFRct values from the HeartFlow analysis to help determine patients’ risk of adverse cardiovascular events and decide on management plans.
The ADVANCE registry was composed of more that 5,000 patients from the United States, Japan, Europe, and Canada who underwent a coronary CTA, and when additional information was needed, a HeartFlow analysis was ordered. The added information contained in the HeartFlow analysis led physicians to reconsider and change management plans for two-thirds of their patients. Some patients who were originally scheduled to undergo coronary artery stenting or bypass operation were safely able to avoid the procedure and be treated with medications alone. Conversely, other patients who would have received medications were redirected to stenting or bypass surgery.
According to HeartFlow, the vast majority of the patients who had a negative HeartFlow analysis received medical therapy and did not receive invasive testing or treatment. At 1 year, patients in this group had a significantly low rate (0.2%) of cardiovascular death or myocardial infarction (MI).
In comparison, the rate of cardiovascular death or MI was four times higher in patients with a positive HeartFlow analysis, many of whom required invasive management. These results demonstrate that patients identified as lower risk for adverse events may be safely treated with medications alone and avoid invasive management. These patients had low rates of revascularization through 90 days and a negligible need for revascularization thereafter.
Dr. Patel commented in the company's announcement, “These findings provide reassurance regarding the safety of patient management utilizing a FFRct-guided decision pathway, particularly in lower-risk patients who did not undergo an invasive evaluation. By adding the HeartFlow FFRct to our available resources for diagnosing stable coronary disease, we are able to provide patients with better care as we efficiently evaluate risk in patients getting a coronary CTA, more precisely stratify patients, and improve efficiency in the cath lab.”