Comparing heart surgery options for patients with severe 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

The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy trial compares the effectiveness of two revascularization methods—coronary artery bypass grafting (CABG) and percutaneous coronary intervention (PCI)—in patients with multivessel coronary artery disease and reduced heart function. This international, multi-center trial will enroll 754 participants and aims to determine which method leads to better outcomes in terms of survival and heart health over a median follow-up of five years. Participants will be randomly assigned to one of the two treatment groups, and the study will gather data on various health outcomes, including death, heart attacks, and hospital readmissions for heart failure.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age \>18 years;
2. LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
3. Prognostically important multivessel CAD (triple vessel CAD or double vessel disease including the left anterior descending (LAD) or LM). Significant coronary stenosis is defined as ≥ 70% based on coronary angiography, and/or fractional flow reserve (FFR) ≤0.80 or instantaneous wave-free ratio (iFR) ≤0.89. For LM disease, significant coronary stenosis is defined as \>50% based on coronary angiography, intravascular ultrasound (IVUS) minimal luminal area (MLA) ≤6.0 mm2 (\<4.5 mm2 Asian descent), or equivalent optical coherence tomography (OCT) measurements;
4. The institutional Heart Team agrees that guideline-directed medical therapy (GDMT) has been initiated for ≥1 month in prevalent and newly diagnosed cases. In patients hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome (ACS)) requiring revascularization before discharge, GDMT needs to be initiated, when possible in-hospital before randomization, with the expectation that it will be titrated to maximally tolerated doses after revascularization;
5. Signed informed consent.

Exclusion Criteria:

1. Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive ventilation or intra-aortic balloon pump/ventricular assist device therapy less than 48 hours prior to randomization;
2. Recent (\<4 weeks) ST-elevation MI;
3. Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
6. Prior cardiac surgery;
7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
8. Circumstances likely to lead to poor treatment adherence;
9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
10. Current pregnancy;
11. Patient not amenable to both CABG or PCI according to the Heart Team;
12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.

Where it's running

• Cedars-Sinai
  Los Angeles, California, United States Recruiting
• Yale University
  New Haven, Connecticut, United States Recruiting
• UofL Health, Inc
  Louisville, Kentucky, United States Recruiting
• John Hopkins Hospital
  Baltimore, Maryland, United States Recruiting
• University Hospitals Cleveland Medical Center
  Cleveland, Ohio, United States Recruiting
• Heart Institute, Medical School of the University of Sao Paulo_INCOR
  São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Stephen Fremes, MD,MSc,FRCSC — Sunnybrook Health Sciences Center, Toronto, Canada
• Study coordinator: Stephen Fremes, MD,MSc,FRCSC
• Email: stephen.fremes@sunnybrook.ca
• Phone: 416-480-6100

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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.