All truths are easy to understand once they are discovered; the point is to discover them.
– Galileo Galilei
Discovery drives clinical research. Whether we are testing a potential breakthrough therapy or the impact of a long-standing care practice, the chance to chart a path toward better heart health is why substantial effort and resources are regularly invested in cardiovascular trials.
The search for a better path is what motivated the PRECISE trial, presented at AHA 2022. This randomized trial delivered strong evidence that a diagnostic pathway centered on coronary CTA + FFRCT, which was recommended in the 2021 AHA/ACC Chest Pain Guideline for the Evaluation and Diagnosis of Chest Pain, provides clinicians and patients with a better pathway for assessing and managing coronary artery disease (CAD).
This global RCT enrolled 2,103 stable symptomatic patients with suspected CAD who were randomized between two pathways:
- Precision Pathway: Risk scoring (using the PROMISE Minimal Risk Score) to defer testing in the lowest-risk patients, and coronary CTA with selective FFRCT for elevated risk patients or low-risk patients if necessary after initial deferral
- Traditional Testing: Functional stress testing or invasive coronary angiography (ICA)
At one year, a 70% reduction in the primary composite endpoint (all-cause death, non-fatal MI, or ICA without obstructive CAD) was found in the Precision Pathway arm, as compared to the Traditional Testing arm.
Moreover, PRECISE allows us to better understand the signals observed in previous trials. Specifically, PRECISE clarifies that, when compared to traditional testing, a diagnostic pathway centered on coronary CTA + FFRCT leads to:
↓ Total ICAs (see PLATFORM)
↓ Negative ICAs (see PLATFORM, FORECAST)
↑ Preventive medical therapies (see SCOT-HEART)
↑ Cath lab efficiency (PCI-to-ICA ratio) (see PLATFORM, FORECAST)
↑ Identification of patients requiring revasc (see Parikh, et al. VA FFR study)
↔ Comparable safety (see FORECAST)
In an effort to better understand the PRECISE trial, I spoke with Dr. James Udelson, the chief of cardiology at Tufts Medical Center and a lead investigator in the PRECISE trial. He shared his perspective, both as a practicing cardiologist and as a clinical trialist.
You can watch this video (7 minutes) of our discussion or you can click on any of the discussed topics below.
- Design & Purpose - “a precision strategy … built on guidelines” (55 seconds)
- Results & Learnings - “strongly in favor of the precision strategy” (30 seconds)
- Surprises - “it’s often surprising when something comes out like you predicted” (30 seconds)
- AHA/ACC Chest Pain Guidelines viewed via PRECISE - “the guidelines are strengthened [with] more evidence to back up those particular recommendations” (60 seconds)
- Use of revascularization in the PRECISE trial - “With an individual patient, [revascularization is] a decision you share with them” (75 seconds)
- Use of preventive medication in the PRECISE trial - “[With coronary CTA] clinicians are seeing more non-obstructive coronary artery disease and … putting people on lipid therapy” (45 seconds)
- Impact on clinical practice - “more accumulating evidence that [coronary CTA + FFRCT] is a very good pathway” (45 seconds)
PRECISE confirms that a better path exists for our patients. And from Dr. Udelson’s comments, it is clear that in the coming months and years this trial will provide more discoveries to inform our daily clinical decisions.
