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Randomized Controlled Trial
. 2025 Sep 23;152(12):846-858.
doi: 10.1161/CIRCULATIONAHA.125.073591. Epub 2025 Sep 5.

Health Status Outcomes With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in ISCHEMIA

Chetan P Huded  1   2 , John A Spertus  1   2 , Philip G Jones  1   2 , Sean M O'Brien  3 , Daniel B Mark  3 , Sripal Bangalore  4 , Gregg W Stone  5 , David O Williams  6 , Harvey D White  7 , William E Boden  8   9 , Harmony R Reynolds  4 , Judith S Hochman  4 , David J Maron  10 ; ISCHEMIA Research Group
Collaborators, Affiliations
Randomized Controlled Trial

Health Status Outcomes With Percutaneous Coronary Intervention and Coronary Artery Bypass Grafting in ISCHEMIA

Chetan P Huded et al. Circulation. .

Abstract

Background: In ISCHEMIA (International Study of Comparative Health Effectiveness With Medical and Invasive Approaches), an invasive strategy demonstrated better health status outcomes than a conservative strategy in patients with chronic coronary disease (CCD). Some previous studies have shown greater health status benefits with coronary artery bypass grafting (CABG) than percutaneous coronary intervention (PCI). Whether the health status benefits of invasive management in ISCHEMIA were driven primarily by participants treated with CABG is unknown.

Methods: The aim of this analysis was to describe the health status outcomes of participants treated with a conservative strategy (n=2232) compared with invasively managed participants treated with PCI (n=1198) or CABG (n=340) in ISCHEMIA. The Seattle Angina Questionnaire-7 summary score (SAQ-SS) and angina frequency score (SAQ-AF) were the primary outcomes, with higher scores indicating better health status. Proportional odds models comparing 1- and 3-year outcomes were fit, adjusting for demographic, clinical, and angiographic characteristics.

Results: SAQ-SS in the conservative, PCI, and CABG groups increased by 9.9±18.1, 15.7±19.3, and 16.1±19.1 points at 1 year and 11.5±20.2, 16.5±21.8, and 15.0±19.4 points at 3 years, respectively. Freedom from angina in the conservative, PCI, and CABG groups was noted in 61.4%, 73.3%, and 82.4% at 1 year and 70.4%, 76.1%, 81.4% at 3 years, respectively. In risk-adjusted analyses, PCI and CABG were each associated with a higher SAQ-SS and SAQ-AF at 1 and 3 years compared with conservative management. SAQ-AF was higher with CABG than PCI at 1 year (odds ratio, 1.54 [95% CI, 1.03, 2.31]), but no differences between CABG and PCI were observed in SAQ-SS (odds ratio, 1.11 [95% CI, 0.78, 1.57]) or SAQ-AF (odds ratio, 0.94 [95% CI, 0.58, 1.54]) at 3 years.

Conclusions: In ISCHEMIA, both PCI and CABG were associated with better 3-year health status than conservative management. Better angina relief with CABG than PCI was seen at 1, but not 3, years.

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

Keywords: coronary artery bypass; coronary disease; health status; myocardial ischemia; percutaneous coronary intervention; quality of life.

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Conflict of interest statement

Dr Huded reports receiving consulting fees from Medtronic and Boston Scientific. Dr Spertus has provided consultative services on patient-reported outcomes and evidence evaluation to Alnylam, AstraZeneca, Bayer, Janssen, Bristol Meyers Squibb, Terumo, Cytokinetics, BridgeBio, VentricHealth, and Imbria; holds research grants from the National Institutes of Health, the Patient-Centered Outcomes Research Institute, the American College of Cardiology Foundation, Lexicon, Imbria, and Janssen; owns the copyright to the Seattle Angina Questionnaire, Kansas City Cardiomyopathy Questionnaire, and Peripheral Artery Questionnaire; and serves on the Board of Directors for Blue Cross Blue Shield of Kansas City. P.G. Jones has nothing to report. Dr O’Brien reports grants from the NHLBI during the conduct of the study. Dr Mark reports grants from the NHLBI during the conduct of the study; grants from HeartFlow, Merck, and Novo Nordisk, outside the submitted work; consulting fees from CeleCor, Boehringer, and Novartis, outside the submitted work; honoraria from Elsevier, outside the submitted work; and a leadership position with the American Heart Association. Dr Bangalore reports grants from the NHLBI during the conduct of the study; grants and personal fees from Abbott Vascular; and personal fees from Biotronik, Pfizer, Amgen, and Reata, outside the submitted work. Dr Williams reports grants from the NHLBI during the conduct of the study. Dr White has received grant support paid to the institution and fees for serving on steering committees from Sanofi-Aventis, Regeneron Pharmaceuticals, Eli Lilly, Omthera Pharmaceuticals, American Regent, Eisai Inc, DalCor Pharma UK Inc, CSL Behring, Sanofi-Aventis Australia Pty Ltd, Esperion Therapeutics Inc, Janssen Pharmaceuticals, and the National Institutes of Health; and was on advisory boards for Genentech Inc and VERVE. Dr Stone has received speaker honoraria from Medtronic, Pulnovo, Infraredx, Abiomed, Amgen, and Boehringer Ingelheim; has served as a consultant to Abbott, Daiichi Sankyo, Ablative Solutions, CorFlow, Cardiomech, Robocath, Miracor, Vectorious, Apollo Therapeutics, Elucid Bio, Cardiac Success, Valfix, TherOx, HeartFlow, Neovasc, Ancora, Occlutech, Impulse Dynamics, Adona Medical, Millennia Biopharma, Oxitope, HighLife, Elixir, Remote Cardiac Enablement, and Aria; and has equity or options from Cardiac Success, Ancora, Cagent, Applied Therapeutics, Biostar family of funds, SpectraWave, Orchestra Biomed, Aria, Valfix, and Xenter. Dr Stone’s employer, Mount Sinai Hospital, receives research grants from Shockwave, Abbott, Abiomed, BioVentrix, Cardiovascular Systems Inc, Phillips, Biosense-Webster, Vascular Dynamics, Pulnovo, and V-wave. Dr Boden reports grants from the NHLBI during the conduct of the study; grants from AbbVie, Amarin, and Amgen; and personal fees from Amgen, Cleveland Clinic Clinical Coordinating Center, and Janssen, outside the submitted work. Dr Reynolds reports grants from the NHLBI during the conduct of the study and nonfinancial support from Abbott Vascular, Philips, SHL Telemedicine, and Siemens, outside the submitted work. Dr Hochman was the principal investigator for ISCHEMIA, for which, in addition to support by an NHLBI 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, and Omron Healthcare Inc, and financial donations from Arbor Pharmaceuticals LLC and AstraZeneca Pharmaceuticals LP; and is principal investigator for ISCHEMIA-EXTEND. Dr Maron reports grants from the NHLBI during the conduct of the study; consulting fees from HeartFlow, Abiomed, Scilex, and Regeneron; lecture honorarium from Mount Sinai Hospital, outside the submitted work; support for attending meetings or travel from ISCHEMIA and Cleerly Inc; stock options from Ablative Solutions, outside the submitted work; and participation on the Executive Board of the American Society for Preventive Cardiology.

Figures

Figure 1 –
Figure 1 –. Study Groups
CABG = coronary artery bypass grafting. CON = conservative strategy. INV = invasive strategy. PCI = percutaneous coronary intervention. QOL = quality of life.
Figure 2 –
Figure 2 –. Propensity Score Distributions
For each pairwise comparison of treatment groups, propensity score distributions for the probability of undergoing one treatment vs. the other is shown, with different colors indicating patients receiving a specific treatment. Propensity scores were constructed using socio-demographics, geographic region, comorbidities, core lab-assessed degree of ischemia, and baseline SAQ, Rose Dyspnea Scale, and EQ-5D scores. For the comparison of PCI and CABG, we additionally included variables obtained from the invasive coronary angiogram: Duke Jeopardy Score, SYNTAX score, left main disease, left anterior descending (LAD) disease, proximal LAD disease, left circumflex disease, right coronary artery disease, number of chronic total occlusion lesions, number of calcified lesions and number of tortuous lesions. CABG = coronary artery bypass grafting. CON = conservative strategy. INV = invasive strategy. PCI = percutaneous coronary intervention.
Figure 3 -
Figure 3 -. Seattle Angina Questionnaire Scores by Revascularization Method
CABG = coronary artery bypass grafting. CON = conservative strategy. PCI = percutaneous coronary intervention. SAQ = Seattle Angina Questionnaire.
Figure 4 –
Figure 4 –. Rose Dyspnea Scale and EQ-5D Scores by Revascularization Method
CABG = coronary artery bypass grafting. CON = conservative strategy. EQ-5D = European Quality of Life 5 Dimensions. PCI = percutaneous coronary intervention.
Figure 5 -
Figure 5 -. Adjusted Odds Ratios for Health Status at 1 Year by Revascularization Method
CABG = coronary artery bypass grafting. CON = conservative strategy. EQ-5D = European Quality of Life 5 Dimensions. PCI = percutaneous coronary intervention. SAQ = Seattle Angina Questionnaire.
Figure 6 -
Figure 6 -. Adjusted Odds Ratios for Health Status at 3 Years by Revascularization Method
CABG = coronary artery bypass grafting. CON = conservative strategy. EQ-5D = European Quality of Life 5 Dimensions. PCI = percutaneous coronary intervention. SAQ = Seattle Angina Questionnaire.
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