Coronary artery disease (CAD), disease of the major blood vessels that supply the heart, is the most common cause of death in the United States. The RECHARGE Trial is a research study in women and minorities to compare the effectiveness of two procedures to restore blood flow to the arteries of the heart. One is a procedure where the blockages are ballooned and then stented with a small wire mesh tube through a small incision in the wrist or the groin) and the other is an open-heart operation where healthy blood vessels from inside the chest, leg, and/or forearm are used to "bypass" the blockages, like a detour). Effectiveness will be measured by comparing survival and improvement in quality-of-life 3-5 years after treatment, and then as long as 10 years after treatment.

Click here to view the detailed project summary on the PCORI website.

Compare length of life and quality of life for 600 women + 600 black and Hispanic patients with coronary artery disease (CAD) who have been under-represented in prior studies and are treated with percutaneous coronary intervention (PCI) compared to coronary artery bypass surgery (CABG).

Clinical Trial Information

The RECHARGE program is integrated by two separately powered multicenter, 1:1 patient randomized, open-label superiority trials, RECHARGE:Women and RECHARGE:Minorities.

Inclusion Criteria

1. Female sex (RECHARGE:Women) and/or Black race or Hispanic ethnicity) and/or Black race or Hispanic/ Hispanic ethnicity (RECHARGE:Minorities)
2. Patient is at least 18 years old
3. Multivessel or left main CAD is present for which revascularization is indicated by the local Heart Team and for which there is equipoise between CABG and PCI
4. Ability to provide written informed consent and comply with all follow-up procedures, including QOL questionnaires

1. ST-segment elevation MI within 3 days
2. Cardiogenic shock
3. Prior PCI within 1 year or any prior CABG
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
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.)

Primary Outcome Measure:

1. 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.
   
   [Time Frame: 5 years]

Secondary Outcome Measure:

2. 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 Frame: 5 years]

Other Pre-specified Outcome Measures:

3. Additional endpoints at various time points
   1. Time-averaged changes in QOL scores, PROMIS-29, EQ5D-VAS, PHQ, and MoCA scores at 1 month, 3months, 6months, 12months and annually after procedure.
   2. Number of days alive and out of hospital after procedure.
   3. Time to: death (all, CV, non-CV), MI, stroke/TIA, hospitalizations, unplanned revasc,AFib/fl utter, composite events VT/VF, heart block, bleeding, vascular complications, heart failure, LVAD/OHT, infections, AKI/CKD, composite events at 1 month, 3months, 6months, 12months and annually after procedure.
   4. Complete and reasonably complete revascularization in the post-procedural period
   5. Change in blood lipids, hemoglobin, LVEF at 12months post-procedure
      
      [Time Frame: 5 years]

*This website was funded through a Patient-Centered Outcomes Research Institute® (PCORI®) Award (PLACER-2022C3-30048).

The views presented on this website are solely the responsibility of the author(s) and do not necessarily represent the views of the other organizations participating in, collaborating with, or funding PCORnet® or of PCORI or other participants in PCORnet. The Patient-Centered Outcomes Research InstituteR (PCORI®) is an independent, nonprofit organization authorized by federal law. Its mission is to fund research that will provide patients, their caregivers, and clinicians with the evidence-based information needed to make better-informed healthcare decisions. PCORI is committed to continually seeking input from a broad range of stakeholders to guide its work.