REvascularization CHoices Among Under-Represented Groups Evaluation: The RECHARGE Trial - Women

Prior treatment

• Prior PCI within 1 year or any in-stent restenosis with diameter stenosis ≥50% or any prior cardiac surgery
• 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
• Current participation in another investigational drug or device study that has not reached its primary endpoint
• Life-expectancy less than 3 years due to concomitant non-cardiac conditions

Other illness

• Planned single vessel revascularization (other than isolated left main disease)
• 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
• 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
• 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.)

Other

• ST-segment elevation MI within 3 days
• Cardiogenic shock
• Planned hybrid revascularization (PCI after CABG or CABG after PCI)

• 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.