학술논문
Comparison of an Initial Risk-Based Testing Strategy vs Usual Testing in Stable Symptomatic Patients With Suspected Coronary Artery Disease: The PRECISE Randomized Clinical Trial.
Document Type
Academic Journal
Author
Douglas PS; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Nanna MG; Section of Cardiovascular Medicine, Yale University School of Medicine, New Haven, Connecticut.; Kelsey MD; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Yow E; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Mark DB; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Patel MR; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.; Rogers C; HeartFlow Inc, Mountain View, California.; Udelson JE; Division of Cardiology and the CardioVascular Center, Tufts Medical Center, Boston, Massachusetts.; Fordyce CB; Division of Cardiology, Department of Medicine, Centre for Cardiovascular Innovation, University of British Columbia, Vancouver, British Columbia, Canada.; Curzen N; Faculty of Medicine, University of Southampton, Cardiothoracic Unit, University Hospital Southampton, Southampton, United Kingdom.; Pontone G; Department of Perioperative Cardiology and Cardiovascular Imaging, Centro Cardiologico Monzino Instituto di Ricovero e Cura a Carattere Scientifico, Milan, Italy.; Department of Biomedical, Surgical and Dental Sciences, University of Milan, Milan, Italy.; Maurovich-Horvat P; MTA-SE Cardiovascular Imaging Research Group, Heart and Vascular Center, Medical Imaging Centre, Semmelweis University, Budapest, Hungary.; De Bruyne B; Cardiovascular Center Aalst, Onze Lieve Vrouwziekenhuis Clinic, Aalst, Belgium.; Department of Cardiology, Lausanne University Hospital, Lausanne, Switzerland.; Greenwood JP; Leeds Institute of Cardiovascular and Metabolic Medicine, University of Leeds, Leeds Teaching Hospitals NHS Trust, United Kingdom.; Marinescu V; Midwest Cardiovascular Institute, Chicago Medical School, Edward-Elmhurst Health, Naperville, Illinois.; Leipsic J; Departments of Radiology and Medicine (Cardiology), University of British Columbia, Vancouver, British Columbia, Canada.; Stone GW; The Zena and Michael A. Wiener Cardiovascular Institute, Icahn School of Medicine at Mount Sinai, New York, New York.; Ben-Yehuda O; University of California San Diego, La Jolla.; Berry C; British Heart Foundation Glasgow Cardiovascular Research Centre, University of Glasgow, United Kingdom.; Hogan SE; CPC Clinical Research, University of Colorado School of Medicine, Aurora.; Redfors B; Cardiovascular Research Foundation, New York, New York.; Department of Cardiology, Sahlgrenska University Hospital, Gothenburg, Sweden.; Ali ZA; St Francis Hospital & Heart Center, Roslyn, New York.; Byrne RA; Department of Cardiology, Cardiovascular Research Institute Dublin, Mater Private Network, Dublin, Ireland.; School of Pharmacy and Biomolecular Sciences, Royal College of Surgeons in Ireland, University of Medicine and Health Sciences, Dublin, Ireland.; Kramer CM; Cardiovascular Medicine, University of Virginia Health, Charlottesville.; Yeh RW; Richard A. and Susan F. Smith Center for Outcomes Research, Beth Israel Deaconess Medical Center, Boston, Massachusetts.; Martinez B; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Mullen S; HeartFlow Inc, Mountain View, California.; Huey W; HeartFlow Inc, Mountain View, California.; Anstrom KJ; University of North Carolina, Chapel Hill.; Al-Khalidi HR; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Department of Biostatistics and Bioinformatics, Duke University School of Medicine, Durham, North Carolina.; Vemulapalli S; Duke Clinical Research Institute, Duke University School of Medicine, Durham, North Carolina.; Division of Cardiology, Duke University School of Medicine, Durham, North Carolina.
Source
Publisher: American Medical Association Country of Publication: United States NLM ID: 101676033 Publication Model: Print Cited Medium: Internet ISSN: 2380-6591 (Electronic) NLM ISO Abbreviation: JAMA Cardiol Subsets: MEDLINE
Subject
Language
English
Abstract
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 < .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.
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 < .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.