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Randomized Controlled Trial
. 2025 Mar;18(3):e010849.
doi: 10.1161/CIRCOUTCOMES.124.010849. Epub 2025 Feb 26.

Evaluating the Appropriate Use Criteria for Coronary Revascularization in Stable Ischemic Heart Disease Using Randomized Data From the ISCHEMIA Trial

James Slater  1 , David J Maron  2 , Philip G Jones  3 , Sripal Bangalore  1 , Harmony R Reynolds  1 , Zhuxuan Fu  3 , Gregg W Stone  4 , Ruth Kirby  5 , Judith S Hochman  1 , John A Spertus  3 ; ISCHEMIA Research Group
Collaborators, Affiliations
Randomized Controlled Trial

Evaluating the Appropriate Use Criteria for Coronary Revascularization in Stable Ischemic Heart Disease Using Randomized Data From the ISCHEMIA Trial

James Slater et al. Circ Cardiovasc Qual Outcomes. 2025 Mar.

Abstract

Background: The appropriate use criteria for revascularization of stable ischemic heart disease have not been evaluated using randomized data. Using data from the randomized ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches; July 2012 to January 2018, 37 countries), the health status benefits of an invasive strategy over a conservative one were examined within appropriate use criteria scenarios.

Methods: Among 1833 participants mapped to 36 appropriate use criteria scenarios, symptom status was assessed using the Seattle Angina Questionnaire-7 at 1 year for each scenario and for each of the 6 patient characteristics used to define the scenarios. Coronary anatomy and SYNTAX(Synergy between percutaneous coronary intervention with Taxus and cardiac surgery) scores were measured using coronary computed tomography angiography. Treatment effects are expressed as an odds ratio for a better health status outcome with an invasive versus conservative treatment strategy using Bayesian hierarchical proportional odds models. Differences in the primary clinical outcome were similarly examined.

Results: The mean age was 63 years, 81% were male, and 71% were White. Diabetes was present in 28% and multivessel disease in 51%. Most clinical scenarios favored invasive for better 1-year health status. The benefit of an invasive strategy on Seattle Angina Questionnaire angina frequency scores was reduced for asymptomatic patients (odds ratio [95% credible interval], 1.16 [0.66-1.71] versus 2.26 [1.75-2.80]), as well as for those on no antianginal medications. Diabetes, number of diseased vessels, proximal left anterior descending coronary artery location, and SYNTAX score did not effectively identify patients with better health status after invasive treatment, and minimal differences in clinical events were observed.

Conclusions: Applying the randomization scheme from the ISCHEMIA trial to appropriate clinical scenarios revealed baseline symptoms and antianginal therapy to be the primary drivers of health status benefits from invasive management. Consideration should be given to reducing the patient characteristics collected to generate appropriateness ratings to improve the feasibility of future data collection.

Registration: URL: https://www.clinicaltrials.gov; Unique identifier: NCT01471522.

Keywords: Bayes theorem; computed tomography angiography; conservative treatment; coronary vessels; myocardial ischemia; questionnaires; random allocation.

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Conflict of interest statement

Dr Maron reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study. Dr Bangalore reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study, grants and personal fees from Abbott Vascular, personal fees from Biotronik, Pfizer, Amgen, and Reata outside of the submitted work. Dr Reynolds reports grants from National Heart, Lung, and Blood Institute; during the conduct of the study, she receives in-kind support for unrelated research from Abbott Vascular, Philips, Scandinavian HealthTelemedicine, and Siemens. Dr Stone reports grants and personal fees from the National Heart, Lung, and Blood Institute during the conduct of the study; speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Apollo Therapeutics, Cardiomech, Gore, Robocath, Miracor, Vectorious, Abiomed, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Elucid Bio, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, Cardiac Success, HighLife; equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Stone’s daughter is an employee at IQVIA. Dr Hochman was the PI for the ISCHEMIA trial (International Study of Comparative Health Effectiveness with Medical and Invasive Approaches) for which, in addition to support by the National Heart, Lung, and Blood Institute grant, devices and medications were provided by Abbott Vascular; Medtronic Inc.; Abbott Laboratories (formerly St. Jude Medical Inc); Royal Philips NV (formerly Volcano Corporation); Arbor Pharmaceuticals LLC; AstraZeneca Pharmaceuticals, LP; Merck Sharp & Dohme Corp.; Omron Healthcare Inc, and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP. She is PI for ISCHEMIA-EXTEND. Dr Spertus reports grants from the National Heart, Lung, and Blood Institute during the conduct of the study and from the American College of Cardiology; personal fees from Bayer, Novartis, AstraZeneca, Amgen, Janssen, United Healthcare, and Blue Cross Blue Shield of Kansas City, outside the submitted work; in addition, Dr Spertus has a patent copyright to the Seattle Angina Questionnaire with royalties paid and Equity in Health Outcomes Sciences. The other authors report no conflicts.

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References

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