This is a research study in women to compare the outcomes of two procedures that restore blood flow to the arteries of the heart. In one procedure the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin. The other procedure is an open-heart operation in which healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages (like a detour). Outcomes will be measured by comparing survival and improvement in quality-of-life.
Female sex
Patient is at least 18 years old.
Multivessel or left main CAD is present for which revascularization is intended and for which there is equipoise between CABG and PCI according to local Heart Team assessment.
Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.
ST-segment elevation MI within 3 days
Cardiogenic shock
Prior PCI within 1 year or any in-stent restenosis with diameter stenosis ≥50% or any prior cardiac surgery
Planned hybrid revascularization (PCI after CABG or CABG after PCI)
Parallel
Coronary artery bypass grafting (CABG)
Procedure/SurgeryCoronary artery bypass grafting (CABG), also called heart bypass surgery, is a medical procedure to improve blood flow to the heart.
Percutaneous coronary intervention (PCI)
Procedure/SurgeryPercutaneous coronary intervention (PCI) is a non-surgical procedure used to treat the blockages in a coronary artery; it opens up narrowed or blocked sections of the artery, restoring blood flow to the heart
Hierarchical composite of all-cause death and time-averaged change from baseline in generic quality of life using the SF-12v2
Generic quality of life (QOL) will be assessed by utilizing the 12-item Short Form Survey (SF-12v2). The score ranges from 1-100, with higher scores indicating a better health status. The win ratio method will be utilized
Time averaged change from baseline in disease-specific quality of life using the SAQ-OS
Disease-specific quality of life (QOL) will be assessed by utilizing the Seattle Angina Questionnaire overall summary (SAQ-OS) score. The score ranges from 1-100, with higher scores indicating a better health status.
Time-averaged changes in PROMIS-29 Scores
The PROMIS-29 instrument measures pain intensity on a scale of 0-10 plus 7 health domains: pain interference, fatigue, sleep disturbance, depressive symptoms, anxiety, physical function, and ability to participate in social roles. Each of the 7 domains is scored separately, with the lowest score for an individual domain being 4 and the highest being 20. Pain intensity is scored on the scale from 1-10. A mean of 50 and a standard deviation of 10 represent the general US population. A T-score rescales the raw scores to standardized scores. For most measures, higher T-scores indicate more of the concept being measured, except for physical function, which is reverse-scored (lower scores indicate worse function).
Time-averaged changes in EQ5D-VAS Scores
The EQ5D-VAS records self-rated health status on a graduated visual analog scale (VAS) from 0-100, with higher scores for higher health-related quality of life. It also includes the EQ-5D descriptive system, which comprises 5 dimensions of health: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Time-averaged changes in PHQ Scores
The Patient Health Questionnaire (PHQ-8) is an 8-item questionnaire used to diagnose and quantify the severity of depressive symptoms. It is designed to evaluate the overall QOL of the individual and questions are based on the diagnostic criteria for Major Depressive Disorder outlined in the Diagnostic and Statistical Manual, 5th Edition (DSM-5). The lowest score is 0 and the highest score is 24. Scores ≥10 suggest a substantial burden of depressive symptoms.
Time-averaged changes in MoCA scores
The telephone Montreal Cognitive Assessment (MoCA Blind or T-MoCA) is a tool to assess mild cognitive impairment. The MoCA BlindT-MoCA consists of 15 non-visual items that assesses different cognitive domains, including attention and concentration, memory, language, conceptual thinking, calculations, and orientation. The maximum score is 22 points with a score of 18 or below signifying mild cognitive dysfunction.
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Weill Medical College of Cornell University
Lead sponsor
Patient-Centered Outcomes Research Institute
Collaborator
Icahn School of Medicine at Mount Sinai
Collaborator
