Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease
Authors: Douglas Pamela S. , Nanna Michael G. , Kelsey Michelle D. , Yow Eric , Mark Daniel B. , Patel Manesh R. , Rogers Campbell , Udelson James E. , Fordyce Christopher B. , Curzen Nick , Pontone Gianluca , Maurovich-Horvat Pál , De Bruyne Bernard , Greenwood John P. , Marinescu Victor , Leipsic Jonathon , Stone Gregg W. , Ben-Yehuda Ori , Berry Colin , Hogan Shea E. , Redfors Bjorn , Ali Ziad A. , Byrne Robert A. , Kramer Christopher M. , Yeh Robert W. , Martinez Beth , Mullen Sarah , Huey Whitney , Anstrom Kevin J. , Al-Khalidi Hussein R. , Vemulapalli Sreekanth ,   PRECISE Investigators, DeMaria Anthony N , Kahn Andrew , Pelberg Robert A. , Pocock Stuart J. , Shah Binita , Issever Ozgu M. , Bonaca Marc , Engel David J. , Jones W. Schuyler , Chow Derek , Cowper Patricia , Daniels Melanie , Li Yanhong , Xing Weibing , Barry Michael , Bloom Stephen , Buck David , Cao Jane , Carstens Jeffrey , Carter Justin , Chow Benjamin , Chrysant George , Cole Jason , Connolly Derek , Daly Ryan , Danciu Sorin , Daubert Melissa , Deano Roderick , Fail Peter , Fairbairn Timothy , Ferencik Maros , Hauser Thomas , Haworth Peter , Hojjati Mohammad , Hoye Angela , Ibrahim Mark , Jan Fuad , Kadalie Clemens , Kalra Dinesh , Karlsberg Ronald , Kindsvater Steven , Kobayashi John , Landers David , Lee James , Litmanovich Diana , Matson Scott , McAllister David , McCann Gerald , Meier Mark , Mejevoi Nicolai , Merkely Bela , Moloo Jamaluddin , Morris Michael , Murphy Darra , Nallamothu Nasar , Narezkina Anna , Nelson Katarina , Nguyen Tuan , Nieman Koen , Nijjar Prabhjot , O'Kane Peter , Patel Amit , Patel Hena , Phiambolis Thomas , Pursnani Amit , Rabbat Mark , Raible Steven , Resnic Frederic , Salerno Michael , Sauri Daniel , Schoepf Uwe O.P.J. , Shah Moneal , Sorrell Vincent , Turner Michael , Walls Michael , Weir-McCall Jonathan , Welt Frederick , Zurick Andrew 
Published: August 2023

Importance

Trials showing equivalent or better outcomes with initial evaluation using coronary computed tomography angiography (cCTA) compared with stress testing in patients with stable chest pain have informed guidelines but raise questions about overtesting and excess catheterization.

Objective

To test a modified initial cCTA strategy designed to improve clinical efficiency vs usual testing (UT).

Design, Setting, and Participants

This was a pragmatic randomized clinical trial enrolling participants from December 3, 2018, to May 18, 2021, with a median of 11.8 months of follow-up. Patients from 65 North American and European sites with stable symptoms of suspected coronary artery disease (CAD) and no prior testing were randomly assigned 1:1 to precision strategy (PS) or UT.

Interventions

PS incorporated the Prospective Multicenter Imaging Study for the Evaluation of Chest Pain (PROMISE) minimal risk score to quantitatively select minimal-risk participants for deferred testing, assigning all others to cCTA with selective CT-derived fractional flow reserve (FFR-CT). UT included site-selected stress testing or catheterization. Site clinicians determined subsequent care.

Main Outcomes and Measures

Outcomes were clinical efficiency (invasive catheterization without obstructive CAD) and safety (death or nonfatal myocardial infarction [MI]) combined into a composite primary end point. Secondary end points included safety components of the primary outcome and medication use.

Results

A total of 2103 participants (mean [SD] age, 58.4 [11.5] years; 1056 male [50.2%]) were included in the study, and 422 [20.1%] were classified as minimal risk. The primary end point occurred in 44 of 1057 participants (4.2%) in the PS group and in 118 of 1046 participants (11.3%) in the UT group (hazard ratio [HR], 0.35; 95% CI, 0.25-0.50). Clinical efficiency was higher with PS, with lower rates of catheterization without obstructive disease (27 [2.6%]) vs UT participants (107 [10.2%]; HR, 0.24; 95% CI, 0.16-0.36). The safety composite of death/MI was similar (HR, 1.52; 95% CI, 0.73-3.15). Death occurred in 5 individuals (0.5%) in the PS group vs 7 (0.7%) in the UT group (HR, 0.71; 95% CI, 0.23-2.23), and nonfatal MI occurred in 13 individuals (1.2%) in the PS group vs 5 (0.5%) in the UT group (HR, 2.65; 95% CI, 0.96-7.36). Use of lipid-lowering (450 of 900 [50.0%] vs 365 of 873 [41.8%]) and antiplatelet (321 of 900 [35.7%] vs 237 of 873 [27.1%]) medications at 1 year was higher in the PS group compared with the UT group (both P &amp;lt; .001).

Conclusions and Relevance

An initial diagnostic approach to stable chest pain starting with quantitative risk stratification and deferred testing for minimal-risk patients and cCTA with selective FFR-CT in all others increased clinical efficiency relative to UT at 1 year. Additional randomized clinical trials are needed to verify these findings, including safety.

Trial Registration

ClinicalTrials.gov Identifier: NCT03702244