Comparing heart procedures for women with coronary artery disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This trial evaluates two procedures for restoring blood flow in women with coronary artery disease: percutaneous coronary intervention (PCI), which involves ballooning and stenting blockages, and coronary artery bypass grafting (CABG), an open-heart surgery that uses healthy blood vessels to bypass blockages. It is a multicenter, randomized trial where participants will be followed for 5-10 years to assess survival rates and quality of life improvements. The study aims to provide insights into the best revascularization options for women, a group often underrepresented in cardiovascular research.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Female sex
2. Patient is at least 18 years old.
3. 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.
4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires.

Exclusion Criteria:

1. ST-segment elevation MI within 3 days
2. Cardiogenic shock
3. Prior PCI within 1 year or any in-stent restenosis with diameter stenosis ≥50% or any prior cardiac surgery
4. Planned hybrid revascularization (PCI after CABG or CABG after PCI)
5. Planned single vessel revascularization (other than isolated left main disease)
6. Need for any cardiac surgical or interventional procedure other than coronary revascularization at the present time or anticipated within 3 years, with the exception that surgical or interventional left atrial appendage ligation or occlusion and/or atrial fibrillation ablation may be performed at site discretion either during or subsequent to the index revascularization procedure
7. Pregnancy (women of child-bearing potential must have a negative pregnancy test within 1 week before randomization) or intent to become pregnant within 1 year after randomization
8. Unable to tolerate, obtain or comply with dual antiplatelet therapy for at least 3 months if presentation with stable CAD or 6 months if presentation with a troponin-positive acute coronary syndrome
9. Current participation in another investigational drug or device study that has not reached its primary endpoint
10. Life-expectancy less than 3 years due to concomitant non-cardiac conditions
11. Any condition(s) are present that are likely to interfere with the study protocol procedures including medication adherence and follow-up through 10 years (e.g. mental disability, substance abuse, anticipated international relocation, etc.)

Where it's running

• Adventist Health Glendale
  Glendale, California, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Ascension St. Vincent Cardiovascular Research Institute
  Carmel, Indiana, United States Recruiting
• Baptist Health Lexington
  Lexington, Kentucky, United States Recruiting
• Baptist Health Louisville
  Louisville, Kentucky, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC — Weill Medical College of Cornell University
• Study coordinator: Mario Gaudino, MD, PhD, MSCE, FEBCTS, FACC
• Email: mfg9004@med.cornell.edu
• Phone: 212.746.1812

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.