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Evaluating the Appropriate Use Criteria for Coronary Revascularization in Stable Ischemic Heart Disease Using
James Slater1, David J Maron2, Philip G Jones3
1NYU Grossman School of Medicine, New York, NY (J.S., S.B., H.R.R., J.S.H.).
Insights
For stable ischemic heart disease, an invasive strategy offers better health status than a conservative one, especially for symptomatic patients. Baseline symptoms and antianginal therapy are key factors influencing invasive treatment benefits.
Area of Science:
- Cardiology
- Interventional Cardiology
- Clinical Trials
Background:
- Appropriate Use Criteria (AUC) for revascularization in stable ischemic heart disease (SIHD) lacked evaluation using randomized trial data.
- The ISCHEMIA trial provided a unique dataset to assess health status benefits of invasive vs. conservative strategies within AUC scenarios.
Purpose of the Study:
- To evaluate the health status benefits of an invasive revascularization strategy compared to a conservative approach in patients with SIHD, stratified by AUC scenarios.
- To determine if patient characteristics used in AUC effectively predict improved health status outcomes with invasive treatment.
Main Methods:
- Utilized data from the randomized ISCHEMIA trial (N=1833) across 36 AUC scenarios.
- Assessed 1-year health status using the Seattle Angina Questionnaire-7 (SAQ-7) and analyzed treatment effects via Bayesian hierarchical proportional odds models.
- Coronary anatomy and SYNTAX scores were evaluated using coronary computed tomography angiography.
Main Results:
- Most scenarios favored an invasive strategy for improved 1-year health status.
- Benefits on angina frequency (SAQ-7) were reduced in asymptomatic patients and those not on antianginal medications.
- Patient factors like diabetes, multivessel disease, and SYNTAX score did not reliably predict better health status outcomes with invasive treatment.
Conclusions:
- Baseline symptoms and antianginal therapy are the primary determinants of health status benefits from invasive management in SIHD patients within AUC.
- Simplifying patient characteristic collection for AUC ratings may enhance future data collection feasibility.
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.
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