Key result
Invasive strategy yields greater 1-year angina relief in younger patients and those with worse baseline symptoms.
Why the study?
The ISCHEMIA trial found that an invasive strategy improved population-level health status compared with a conservative strategy in chronic coronary disease, but translating these results to individual patients remained unclear.
Does an invasive management strategy compared with a conservative strategy differentially improve 1-year angina-related health status (SAQ Summary Score) across specific baseline patient characteristics in patients with chronic coronary disease and moderate-to-severe ischemia?
RCT (n=4,617)
Open-label (patients were unblinded to treatment assignment; blinded coronary computed tomography angiography was performed at baseline)
Randomized to invasive or conservative strategy before angiography
Yes
Does an invasive management strategy compared with a conservative strategy differentially improve 1-year angina-related health status (SAQ Summary Score) across specific baseline patient characteristics in patients with chronic coronary disease and moderate-to-severe ischemia?
In patients with chronic coronary disease and moderate-to-severe ischemia, younger patients and those with worse baseline angina burden derive the greatest 1-year health status benefit from invasive management, which can be estimated individually using a newly developed clinical prediction tool to support shared decision-making.
Answers are grounded in this paper and cite their sources.
Younger patients and those with worse baseline angina gain more health status benefit from invasive strategy; extends ISCHEMIA by identifying treatment effect modifiers for shared decisions.
Background The ISCHEMIA trial found that patients with chronic coronary disease randomized to invasive strategy had better health status than those randomized to conservative strategy. It is unclear how best to translate these population-level results to individual patients. Objectives The authors sought to identify patient characteristics associated with health status from invasive and conservative strategies, and develop a prediction algorithm for shared decision-making. Methods One-year disease-specific health status was assessed in ISCHEMIA with the Seattle Angina Questionnaire (SAQ) Summary Score (SAQ SS) and Angina Frequency, Physical Limitations (PL), and Quality of Life (QL) domains (range 0-100, higher = less angina/better health status). Results Among 4,617 patients from 320 sites in 37 countries, mean SAQ SS was 74.1 ± 18.9 at baseline and 85.7 ± 15.6 at 1 year. Lower baseline SAQ SS and younger age were associated with better 1-year health status with invasive strategy (P interaction = 0.009 and P interaction = 0.004, respectively). For the individual domains, there were significant treatment interactions for baseline SAQ score (Angina Frequency, PL), age (PL, QL), anterior ischemia (PL), and number of baseline antianginal medications (QL), with more benefit of invasive in patients with worse baseline health status, younger age, anterior ischemia, and on more antianginal medications. Parsimonious prediction models were developed for 1-year SAQ domains with invasive or conservative strategies to support shared decision-making. Conclusions In the management of chronic coronary disease, individual patient characteristics are associated with 1-year health status, with younger age and poorer angina-related health status showing greater benefit from invasive management. This prediction algorithm can support the translation of the ISCHEMIA trial results to individual patients. (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches [ISCHEMIA]; NCT01471522).
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Arnold et al. (2024) conducted an RCT in Chronic coronary disease with moderate-to-severe ischemia (n=4,617). Invasive management strategy (coronary angiography and revascularization with PCI or CABG plus medical therapy) vs. Conservative management strategy (guideline-directed medical therapy alone, with angiography reserved for medical therapy failure or suspected acute ischemic event) was evaluated on 1-year Seattle Angina Questionnaire Summary Score (SAQ SS) (p=0.009 for interaction with baseline SAQ SS; 0.004 for interaction with age). Invasive strategy yielded greater 1-year SAQ Summary Score improvements in patients with lower baseline scores (P interaction=0.009) and younger age (P interaction=0.004) vs conservative care.
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