Comparison of a Precision Care Strategy With Usual Testing to Guide Management of Stable Patients With Suspected Coronary Artery Disease: The Precise Randomized Trial

Presented at the AHA Scientific Sessions 2022 by: Prof. Pamela S. Douglas, MD - Durham, NC, USA

Introduction and methods

The AHA/ACC, ESC, and NICE practice guidelines recommend evaluation goals to ensure proper assessment and management of patients with new-onset stable chest pain. These goals include reduction of unnecessary testing by risk stratification and deferred testing, improvement of diagnostic yield of testing and catheterization, and reduction of complications and costs by serving as a gatekeeper to invasive testing. To determine the best care pathway to meet these goals, the PRECISE (Prospective Randomized Trial of the Optimal Evaluation of Cardiac Symptoms and Revascularization) study was conducted.

In this RCT, 2103 patients with stable, nonacute chest pain (or equivalent) who required testing for suspected CAD were randomized to a precision strategy or usual testing. Inclusion criteria were no history of obstructive CAD and no CAD testing <1 year ago. The precision strategy consisted of a care pathway that incorporated a set of actions based on guideline recommendations. In the precision strategy arm, testing was prioritized by the PROMISE (Prospective Multicenter Imaging Study for Evaluation of Chest Pain) Minimal Risk Score: (1) patients with a low risk score were assigned to deferred testing; and (2) patients with an elevated risk score underwent coronary CT angiography with selective fractional flow reserve. In the usual testing arm, the site clinician selected the testing (i.e., functional testing or direct catheterization). For both study arms, the site clinician made all subsequent care and testing decisions; guideline-directed medical management was recommended but not required.

The primary endpoint was a composite outcome of all-cause mortality, nonfatal MI, or catheterization without obstructive CAD after 1 year. Secondary effectiveness endpoints included the percentage of positive tests, the number of diagnostic catheterizations, and the use of lipid-lowering, antiplatelet, or antihypertensive medication.

Main results

• After a median follow-up duration of 11.8 months, 4.2% of the patients in the precision strategy group and 11.3% of those in the usual testing group met the primary endpoint (hazard ratio (HR): 0.35; 95%CI: 0.25–0.50). After adjusting for age, sex, CAD equivalent, and intended first test, the HR was 0.29 (95%CI: 0.20–0.41; P<0.001).
• This decrease in occurrence of the primary endpoint was driven by a reduction in catheterization without obstructive CAD in the precision strategy group (2.6% vs. 10.2%; adjusted HR: 0.18; 95%CI: 0.12–0.30); the incidence rates of all-cause mortality and nonfatal MI were not significantly different between the 2 groups.
• Of note, there were no deaths or MI events in the precision strategy group that underwent deferred testing.
• Analyses of subgroups (stratified by, among others, age, gender, or 10-year ASCVD event risk score) showed results that mostly favored the precision strategy.
• In the precision strategy group, less tests were performed than in the usual testing group and more tests were positive (18.3% vs. 13.3%; P<0.01).
• Patients in the precision strategy group underwent fewer diagnostic catheterizations than those in the usual testing group (135 vs. 177), were less likely to have undergone catheterization without obstructive CAD (20% vs. 60%), and were less likely to have undergone catheterization without revascularization (28% vs. 70%).
• Compared with the usual testing group, a larger percentage of patients in the precision strategy group were taking lipid-lowering medication (P<0.001) or antiplatelet medication (P<0.001) at the end of follow-up.

Conclusion

In stable, symptomatic patients with suspected CAD, a precision strategy based on clinical guideline recommendations resulted in a 70%-reduction in all-cause mortality, nonfatal MI, or catheterization without obstructive CAD after 1 year compared with a strategy of usual testing.

• Our reporting is based on the information provided at the AHA Scientific Sessions -

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