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

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

The ISCHEMIA-HF trial will randomize participants with multivessel coronary artery disease (CAD) with ejection fraction (EF) ≤40% in a 1:2:2 fashion to guideline-directed medical therapy (GDMT):coronary artery bypass grafting (CABG):percutaneous coronary intervention (PCI).

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)