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Randomized Controlled Trial
. 2024 Apr 16;83(15):1353-1366.
doi: 10.1016/j.jacc.2024.02.019.

Variation in Health Status With Invasive vs Conservative Management of Chronic Coronary Disease

Suzanne V Arnold  1 , Philip G Jones  2 , David J Maron  3 , David J Cohen  4 , Daniel B Mark  5 , Harmony R Reynolds  6 , Sripal Bangalore  6 , Jiyan Chen  7 , Jonathan D Newman  6 , Robert A Harrington  3 , Gregg W Stone  8 , Judith S Hochman  6 , John A Spertus  2 ; ISCHEMIA Research Group
Affiliations
Randomized Controlled Trial

Variation in Health Status With Invasive vs Conservative Management of Chronic Coronary Disease

Suzanne V Arnold et al. J Am Coll Cardiol. .

Abstract

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).

Keywords: chronic coronary disease; coronary artery disease; quality of life; stable angina.

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Conflict of interest statement

Funding Support and Author Disclosures The research reported in this paper was funded through grants from National Institutes of Health/National Heart, Lung, and Blood Institute grants U01HL105907, U01HL105462, U01HL105561, and U01HL105565, Arbor Pharmaceuticals, AstraZeneca Pharmaceuticals, and Clinical and Translational Science Awards from the National Center for Advancing Translational Sciences (11UL1 TR001445 and UL1 TR002243). Devices or medications were provided by Abbott Vascular, Medtronic, St Jude Medical, Volcano, Amgen, Arbor Pharmaceuticals, AstraZeneca Pharmaceuticals, Espero Pharmaceuticals, Merck Sharp & Dohme, Omron Healthcare, and Sunovion Pharmaceuticals. Contents of this paper are solely the responsibility of the authors and do not necessarily represent official views of the National Heart, Lung, and Blood Institute, the National Institutes of Health, or the Department of Health and Human Services. Dr Cohen has received research grant support from Abbott, Boston Scientific, Edwards Lifesciences, Philips, CathWorks, Zoll Medical, and I-Rhythm; and has received consulting income from Abbott, Boston Scientific, Edwards Lifesciences, and Medtronic. Dr Reynolds has received in-kind support for unrelated research from Abbott Vascular, Siemens, and BioTelemetry. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has been a 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, and HighLife; holds equity/options from Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Cardiac Success, Valfix, and Xenter; and receives institutional research grants from Abbott, Abiomed, Bioventrix, Cardiovascular Systems Inc, Phillips, Biosense Webster, Shockwave, Vascular Dynamics, Pulnovo, and V-wave. Dr Spertus owns the copyright to the Seattle Angina Questionnaire; has received consulting income from Janssen, Bayer, AstraZeneca, Novartis, and Merck; serves on the cardiovascular scientific advisory board of United Healthcare; is on the board of directors for Blue Cross Blue Shield of Kansas City; and holds equity interest in Health Outcomes Sciences. All other authors have reported that they have no relationships relevant to the contents of this paper to disclose.

Figures

Figure 1.
Figure 1.. Effects of Invasive Strategy on 1-Year SAQ by Patient Factors.
A. SAQ Summary Score. B. SAQ Angina Frequency Score. C. SAQ Physical Limitations Score. D. SAQ Quality of Life Score. Odds of having a higher SAQ score at 1 year with invasive versus conservative treatment. Continuous variables were included in the models as continuous variables but are displayed in the figures with ORs at particular values, for illustration purposes. P-value indicates the interaction of treatment strategy by that particular variable, in a model that also included all other variables as main effects. SAQ, Seattle Angina Questionnaire; SS, Summary Score; AF, Angina Frequency; PL, Physical Limitations; QL, Quality of Life
Figure 1.
Figure 1.. Effects of Invasive Strategy on 1-Year SAQ by Patient Factors.
A. SAQ Summary Score. B. SAQ Angina Frequency Score. C. SAQ Physical Limitations Score. D. SAQ Quality of Life Score. Odds of having a higher SAQ score at 1 year with invasive versus conservative treatment. Continuous variables were included in the models as continuous variables but are displayed in the figures with ORs at particular values, for illustration purposes. P-value indicates the interaction of treatment strategy by that particular variable, in a model that also included all other variables as main effects. SAQ, Seattle Angina Questionnaire; SS, Summary Score; AF, Angina Frequency; PL, Physical Limitations; QL, Quality of Life
Figure 1.
Figure 1.. Effects of Invasive Strategy on 1-Year SAQ by Patient Factors.
A. SAQ Summary Score. B. SAQ Angina Frequency Score. C. SAQ Physical Limitations Score. D. SAQ Quality of Life Score. Odds of having a higher SAQ score at 1 year with invasive versus conservative treatment. Continuous variables were included in the models as continuous variables but are displayed in the figures with ORs at particular values, for illustration purposes. P-value indicates the interaction of treatment strategy by that particular variable, in a model that also included all other variables as main effects. SAQ, Seattle Angina Questionnaire; SS, Summary Score; AF, Angina Frequency; PL, Physical Limitations; QL, Quality of Life
Figure 1.
Figure 1.. Effects of Invasive Strategy on 1-Year SAQ by Patient Factors.
A. SAQ Summary Score. B. SAQ Angina Frequency Score. C. SAQ Physical Limitations Score. D. SAQ Quality of Life Score. Odds of having a higher SAQ score at 1 year with invasive versus conservative treatment. Continuous variables were included in the models as continuous variables but are displayed in the figures with ORs at particular values, for illustration purposes. P-value indicates the interaction of treatment strategy by that particular variable, in a model that also included all other variables as main effects. SAQ, Seattle Angina Questionnaire; SS, Summary Score; AF, Angina Frequency; PL, Physical Limitations; QL, Quality of Life
FIGURE 2.
FIGURE 2.. Example output of models for shared decision-making.
A. Example patient #2: 58 year old female from North America with diabetes, ejection fraction 60%, serum creatinine 1 mg/dL, on 2 anti-anginal medications, moderate ischemia on stress testing, no multivessel disease by coronary CT angiography, and SAQ7-summary score=52. B. Example patient #3: 71 year old male from North America with no diabetes, ejection fraction 60%, serum creatinine 1 mg/dL, on 0 anti-anginal medications, severe ischemia on stress testing, no multivessel disease by coronary CT angiography, and SAQ7-summary score=90.
FIGURE 2.
FIGURE 2.. Example output of models for shared decision-making.
A. Example patient #2: 58 year old female from North America with diabetes, ejection fraction 60%, serum creatinine 1 mg/dL, on 2 anti-anginal medications, moderate ischemia on stress testing, no multivessel disease by coronary CT angiography, and SAQ7-summary score=52. B. Example patient #3: 71 year old male from North America with no diabetes, ejection fraction 60%, serum creatinine 1 mg/dL, on 0 anti-anginal medications, severe ischemia on stress testing, no multivessel disease by coronary CT angiography, and SAQ7-summary score=90.
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