Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected...

Area of Science:

• Cardiology
• Diagnostic Imaging
• Clinical Trials

Background:

• Current guidelines recommend initial coronary computed tomography angiography (cCTA) for stable chest pain, but concerns exist regarding overtesting and unnecessary catheterizations.
• A modified cCTA strategy aims to enhance clinical efficiency compared to usual testing (UT).

Purpose of the Study:

• To evaluate a precision strategy (PS) incorporating risk stratification and cCTA with selective CT-derived fractional flow reserve (FFR-CT) against usual testing (UT) for stable chest pain.
• To assess the impact of this modified cCTA strategy on clinical efficiency and patient safety.

Main Methods:

• A pragmatic randomized clinical trial involved 2103 patients with stable chest pain across 65 North American and European sites.
• Patients were randomized to either the precision strategy (PS) or usual testing (UT).
• The PS group used the PROMISE minimal risk score for deferred testing in low-risk patients, with others undergoing cCTA and selective FFR-CT. UT involved site-selected stress testing or catheterization.

Main Results:

• The primary endpoint (clinical efficiency and safety composite) occurred in 4.2% of the PS group versus 11.3% in the UT group (HR, 0.35).
• Clinical efficiency was significantly higher in the PS group, with substantially lower rates of catheterization without obstructive coronary artery disease (2.6% vs 10.2%).
• The composite safety endpoint of death or myocardial infarction (MI) was similar between groups, though nonfatal MI rates were higher in the PS group (1.2% vs 0.5%).

Conclusions:

• An initial diagnostic approach using quantitative risk stratification, deferred testing for minimal-risk patients, and cCTA with selective FFR-CT for others significantly improved clinical efficiency in stable chest pain patients.
• While the strategy demonstrated higher clinical efficiency, further randomized trials are needed to confirm these findings, particularly regarding safety outcomes.
• Increased use of lipid-lowering and antiplatelet medications was observed in the PS group at one year.