International Study of Comparative Health Effectiveness With Medical and Invasive Approaches-Left Ventricular Dysfunction Trial

• Guideline-directed medical therapy (GDMT) (Procedure): Participants receive guideline-directed medical therapy (GDMT).
• Coronary artery bypass grafting (CABG) (Procedure): Participants receive coronary artery bypass grafting (CABG).
• Percutaneous coronary intervention (PCI). (Procedure): Participants receive percutaneous coronary intervention (PCI).

Primary outcomes

• Composite Cognitive Score [Month 12]: A composite score of various cognitive measures. Note that the total score range, calculation and interpretation to be updated upon submission of study protocol/materials to NYU Grossman School of Medicine IRB.
• Kansas City Cardiomyopathy Questionnaire (KCCQ) Score [Month 12]: The KCCQ is an 8-item assessment of heart failure (HF)-related health status. The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges, where scores represent health status as follows: 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
• Composite Number of: Death, Nonfatal Myocardial infarction (MI), Stroke, and Hospitalization for HF [Month 12]: Composite calculation of the number participants who experience death, nonfatal MI, stroke, or hospitalization for HF in each arm.

Secondary outcomes

• Composite Number of: Mild Cognitive Impairment (MCI), Probable Dementia or Persistent Disability [Month 12]: Composite calculation of the number of participants with MCI, probable dementia or persistent disability in each arm.
• Composite Number of: Death or Hospitalization for HF [Month 12]: Composite calculation of the number of participants who die or are hospitalized for HF in each arm.
• Composite Number of: Death or Hospitalization for Cardiovascular (CV) Cause [Month 12]: Composite calculation of the number of participants who die or are hospitalized due to CV-related causes in each arm.
• Seattle Angina Questionnaire (SAQ) Physical Limitations and Quality of Life Domain Score [Month 12]: The SAQ Physical Limitations and Quality of Life domain comprises 2 items of the SAQ corresponding with angina-related physical limitations and quality of life (QOL). The raw score is calculated using the response to each item; the total score transforms the raw score to a standardized score scaled from 0 to 100 and summarized in 25-point ranges where: 0 to 24 represents poor health status, 25 to 49 represents fair status, 50 to 74 represents good status, and 75 to 100 represents excellent status.
• Self-Care of Heart Failure Index (SCHFI) [Month 12]: The SCHFI is a 39-item questionnaire assessing HF patients' performance of self-care activities related to HF, including how often they complete self-care, how likely they are to perform certain activities, and how confident they feel in performing the activities. Each item is rated on a scale from 1-5; the total score is the sum of responses and ranges from 39-195. Higher scores indicate greater overall performance of self-care activities related to HF.

Sex: All, ages: 55 Years to any

Inclusion Criteria:

* Left ventricular ejection fraction (LVEF) ≤ 40% within prior 6 months (any local measurement, made within the past 6 months using echocardiography, multigated acquisition (MUGA), computed tomography (CT) scanning, magnetic resonance imaging (MRI), or ventricular angiography is acceptable, provided no subsequent measurement above 40%)
* Participants with multivessel CAD (defined as severe 3 vessel disease or 2 vessel disease including left anterior descending (LAD) artery disease) on coronary CT angiography (CCTA) or invasive coronary angiography
* CAD amenable to either PCI or CABG as determined by the local heart team
* Participant is willing to comply with all aspects of the protocol, including adherence to the assigned strategy, medical therapy and follow-up visits
* Participant is able and willing to give written informed consent

Exclusion Criteria:

* Decompensated heart failure or cardiogenic shock in the past 48 hours prior to randomization
* Concomitant significant valvular heart disease requiring surgery
* Prior cardiac surgery
* Dementia with loss of capacity to consent (clinically evident or previously diagnosed)
* Stroke within the previous 6 months or spontaneous intracranial hemorrhage at any time
* History of noncompliance with medical therapy
* Life expectancy less than the duration of the trial due to non-cardiovascular comorbidity
* Pregnancy (known to be pregnant; to be confirmed before randomization, if applicable)

• S. Bangalore, MD, Principal investigator, NYU Langone Health