Comparing heart surgery options for patients with severe coronary artery disease
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
This study is testing which heart surgery option, either bypass surgery or a less invasive procedure, works better for people with severe coronary artery disease and weakened heart function.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 754 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sunnybrook Health Sciences Centre Academic / other |
| Locations | 43 sites (Los Angeles, California and 42 other locations) |
| Trial ID | NCT05427370 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with significant multivessel coronary artery disease and reduced left ventricular ejection fraction.
Not a fit: Patients with single-vessel coronary artery disease or those who are not candidates for revascularization may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide clearer guidance on the best surgical approach for patients with severe coronary artery disease and heart dysfunction, potentially improving survival and quality of life.
How similar studies have performed: Previous studies have shown mixed results regarding the comparison of PCI and CABG, making this trial a significant effort to provide more definitive evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Los Angeles, California and 42 other locations
- 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)
- Mayo Clinic — Rochester, Minnesota, United States (Withdrawn)
- University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States (Recruiting)
- Medical University of Vienna — Vienna, Austria (Active_not_recruiting)
- Heart Institute, Medical School of the University of Sao Paulo_INCOR — São Paulo, Brazil (Recruiting)
- University of Calgary; Libin Cardiovascular Institute — Calgary, Alberta, Canada (Recruiting)
- Mackenzie Health Sciences Center — Edmonton, Alberta, Canada (Recruiting)
- Fraser Health; Royal Columbian Hospital — New Westminster, British Columbia, Canada (Withdrawn)
- Providence Health — Vancouver, British Columbia, Canada (Recruiting)
- The University of Manitoba and St. Boniface Hospital Inc. — Winnipeg, Manitoba, Canada (Recruiting)
- Queen Elizabeth II Hospital — Halifax, Nova Scotia, Canada (Recruiting)
- Hamilton General Hospital — Hamilton, Ontario, Canada (Recruiting)
- London Health Sciences Center, University Hospital — London, Ontario, Canada (Recruiting)
- Southlake Regional HC — Newmarket, Ontario, Canada (Recruiting)
- Ottawa Heart Institute — Ottawa, Ontario, Canada (Recruiting)
- Sunnybrook Health Sciences Center — Toronto, Ontario, Canada (Recruiting)
- St. Michael's — Toronto, Ontario, Canada (Recruiting)
- Toronto General Hospital — Toronto, Ontario, Canada (Recruiting)
- Center Hospitalier Universitaire de Montreal — Montreal, Quebec, Canada (Recruiting)
- Montreal Heart Institute — Montreal, Quebec, Canada (Recruiting)
- Hospital Sacre-Coeur — Montreal, Quebec, Canada (Recruiting)
- Institut de Cardiologie Quebec (QC) - Laval — Québec, Quebec, Canada (Recruiting)
- Jilin Heart Hospital — Jilin, Changchun, China (Recruiting)
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine — Shanghai, China (Recruiting)
- Clinical Hospital Dubrava — Sušak, Zagreb, Croatia (Recruiting)
- Al Nas Hospital — Cairo, Qalyubia Governorate, Egypt (Recruiting)
- University Hospital Dusseldorf — Düsseldorf, Germany (Recruiting)
- Leipzig Heart Center — Leipzig, Germany (Recruiting)
- G Kuppuswamy Naidu Memorial Hospital (GKNM) — Palayam, Tamil Nadu, India (Recruiting)
- European Hospital, Via Portuense — Roma, Rm, Italy (Recruiting)
- Instituto Mexicano del Seguro Social (IMSS) — Mexico City, Mexico (Recruiting)
- Medical University Bialystok — Bialystok, Poland (Recruiting)
- Medical University of Silesia — Katowice, Poland (Active_not_recruiting)
- Unidade Local de Saude Lisboa Ocidental (ULSLO) — Lisbon, Portugal (Recruiting)
- Centro Hospitalar e Universitário Sao João — Porto, Portugal (Recruiting)
- Dedinje Cardiovascular Institute — Belgrade, Serbia (Recruiting)
- Hospital Clinic de Barcelona (ICCV) — Barcelona, L'Eixample, Spain (Recruiting)
- Hospital Clínico Universitario Virgen de la Arrixaca — El Palmar, Murcia, Spain (Recruiting)
- Hospital del Vinalopó — Alicante, Spain (Recruiting)
- Hospital Universitario de Navarra — Pamplona, Spain (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.