The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
- Conditions
- Coronary Artery DiseaseHeart Failure Systolic
- Interventions
- Procedure: Revascularization by PCIProcedure: Revascularization by CABG
- Registration Number
- NCT05427370
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy (STICH3C) trial is a prospective, unblinded, international multi-center randomized trial of 754 subjects enrolled in approximately 45 centers comparing revascularization by percutaneous coronary intervention (PCI) vs. coronary artery bypass grafting (CABG) in patients with multivessel/left main (LM) coronary artery disease (CAD) and reduced left ventricular ejection fraction (LVEF).
The primary objective is to determine whether CABG compared to PCI is associated with a reduction in all-cause death, stroke, spontaneous myocardial infarction (MI), urgent repeat revascularization (RR), or heart failure (HF) readmission over a median follow-up of 5 years in patients with multivessel/LM CAD and ischemic left ventricular dysfunction (iLVSD).
Eligible patients are considered by the local Heart Team appropriate and amenable for non-emergent revascularization by both modes of revascularization.
The secondary objectives are to describe the early risks of both procedures, and a comprehensive set of patient-reported outcomes longitudinally.
- Detailed Description
The evidence comparing PCI and CABG with medical therapy in patients with iLVSD has been the subject of multiple systematic reviews/meta-analyses of observational studies with inconsistent results. There is a current lack of evidence from properly powered randomized trials comparing contemporary state-of-the-art PCI vs. CABG to guide the clinical management in the vulnerable population of patients with iLVSD. Understanding the relative impact of both revascularization strategies on clinical outcomes in this prevalent population would have important clinical implications.
The overarching aim of the STICH3C trial is to compare the clinical efficacy and safety of contemporary PCI and CABG to treat patients with multivessel/left main (LM) CAD and iLVSD.
Participants will be allocated in a 1:1 ratio to either study arm using permuted block randomization stratified for study center and acute coronary syndrome (ACS) presentation through a centrally controlled, automated, web system. Eligible patients who provide informed consent can be enrolled. It is expected that initial revascularization will take place within 2 weeks of randomization. Staged PCI is expected to take place within 90 days of randomization. The recruitment will occur over 3 years, with a total study duration of 7 years, and a median duration of follow-up of 5 years.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 754
- Age >18 years;
- LVEF ≤40% quantified by either echocardiography, SPECT ventriculography, or magnetic resonance within 2 months of randomization;
- 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;
- 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;
- Signed informed consent.
- 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;
- Recent (<4 weeks) ST-elevation MI;
- Concomitant severe valvular disease or other condition such as left ventricular aneurysm requiring surgical repair or replacement;
- Planned major concomitant surgical procedures (LAAO and AF ablation surgical procedures permitted);
- Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs contributing to the primary outcome);
- Prior cardiac surgery;
- Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;
- Circumstances likely to lead to poor treatment adherence;
- Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure, cancer) that reduces life expectancy to less than 5 years;
- Current pregnancy;
- Patient not amenable to both CABG or PCI according to the Heart Team;
- Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Revascularization by PCI Revascularization by PCI Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>2.0 mm for PCI. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon. Revascularization by CABG Revascularization by CABG Revascularization will be attempted on/for significant lesions in major coronary vessels/side branches as planned by the local Heart Team, with the general recommendation of stenotic/occluded vessels with diameter \>1.5 mm for CABG. The Heart Team consists of a minimum of one heart failure cardiologist, one interventional cardiologist and one cardiac surgeon
- Primary Outcome Measures
Name Time Method The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission. Median follow-up of 5 years. Time to event outcome measured as the time from randomization to the occurence of the first event.
- Secondary Outcome Measures
Name Time Method Myocardial Infarction (MI) At 30 days and through study completion with a median follow-up of 5 years. Periprocedural/perioperative MI is defined as \<48 hours from revascularization. Spontaneous MI is defined as \> or = 48 hours post revascularization
Death At 30 days , 90 days and through study completion with a median follow-up of 5 years. Death will be reported at 30 days. Death over the entire duration of study will be reported as a time to event outcome. Death will be adjudicated as cardiovascular, non-cardiovascular and unknown.
Coronary composite endpoint Through study completion with a median follow-up of 5 years. Coronary heart disease death, non-fatal MI, and coronary revascularization procedure. Measured as time-to-event outcome.
Number of participants with advanced Heart failure therapies Through study completion with a median follow-up of 5 years. This includes - ICD/CRT implantation,Mitral valve repair (transcatheter/surgical),Ventricular Assist Device and Heart Transplant
Number of participants with Stroke At 30 days , 90 days and through study completion with a median follow-up of 5 years. Strokes will be classified as ischemic, hemorrhagic or uncertain.
Composite of death/stroke/spontaneous MI Through study completion with a median follow-up of 5 years. Measured as a time-to-event.
Major Adverse Events Results will be reported at 30 days and 90 days after index procedure (and 30 days after any planned staged PCI, allowed up to 90 days after randomization) as cardiac surgical hospitalizations maybe prolonged. These will be reported as the composite and individually: new renal replacement therapy, major bleeding (Bleeding Academic Research Consortium (BARC) 3-5), major vascular complication (according to VARC-2 criteria), unplanned RR, other reoperation, surgical site complication, intubation \>48 hours, cardiac arrest, advanced cardiac life support, stroke and death.
Composite of death or cardiac hospitalization Through study completion with a median follow-up of 5 years. Measured as a time-to-event.
Heart Failure endpoint Through study completion with a median follow-up of 5 years. Heart Failure Event (composite of heart failure death, heart failure hospitalization or revascularization for HF). Measured as time-to-event outcome.
Repeat Revascularization (RR) At 30 days , 90 days and through study completion with a median follow-up of 5 years. Only urgent clinically driven unplanned repeat revascularizations by either PCI or CABG count towards primary ouctome. RR will be classified according to type (CABG vs. PCI), by location (target vessel vs. target lesion vs. graft vs. other), and whether clinically vs. non-clinically driven. Stent thrombosis (ARC defined) and graft thrombosis/ occlusion will be reported.
Hospitalizations Through study completion with a median follow-up of 5 years. Hospitalizations will be defined as cardiac or non-cardiac. Hospitalizations will be reported as the number of participants with hospitalizations and as a count.
Composite of death/stroke/spontaneous MI/RR Through study completion with a median follow-up of 5 years. Measured as a time-to-event.
Hierarchal Heart Failure outcome Through study completion with a median follow-up of 5 years. The key hierarchal outcome of time to death and frequency of HF rehospitalizations will be tested using a win ratio
Trial Locations
- Locations (37)
Cedars-Sinai
🇺🇸Los Angeles, California, United States
UofL Health, Inc
🇺🇸Louisville, Kentucky, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
Medical University of Vienna
🇦🇹Vienna, Austria
Institute of Cardiology
🇧🇷Porto Alegre, Brazil
Heart Institute, Medical School of the University of Sao Paulo_INCOR
🇧🇷São Paulo, Brazil
University of Calgary; Libin Cardiovascular Institute
🇨🇦Calgary, Alberta, Canada
Mackenzie Health Sciences Center
🇨🇦Edmonton, Alberta, Canada
Fraser Health; Royal Columbian Hospital
🇨🇦New Westminster, British Columbia, Canada
Providence Health
🇨🇦Vancouver, British Columbia, Canada
Queen Elizabeth II Hospital
🇨🇦Halifax, Nova Scotia, Canada
Hamilton General Hospital
🇨🇦Hamilton, Ontario, Canada
London Health Sciences Center, University Hospital
🇨🇦London, Ontario, Canada
Southlake Regional HC
🇨🇦Newmarket, Ontario, Canada
Ottawa Heart Institute
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Center
🇨🇦Toronto, Ontario, Canada
St. Michael's
🇨🇦Toronto, Ontario, Canada
Toronto General Hospital
🇨🇦Toronto, Ontario, Canada
Center Hospitalier Universitaire de Montreal
🇨🇦Montréal, Quebec, Canada
Montreal Heart Institute
🇨🇦Montréal, Quebec, Canada
Jewish General Hospital
🇨🇦Montréal, Quebec, Canada
Hospital Sacre-Coeur
🇨🇦Montréal, Quebec, Canada
Institut de Cardiologie Quebec (QC) - Laval
🇨🇦Québec, Quebec, Canada
Jilin Heart Hospital
🇨🇳Jilin, Changchun, China
Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
🇨🇳Shanghai, China
Clinical Hospital Dubrava
🇭🇷Sušak, Zagreb, Croatia
University Hospital Dusseldorf
🇩🇪Düsseldorf, Germany
G Kuppuswamy Naidu Memorial Hospital (GKNM)
🇮🇳Palayam, Tamil Nadu, India
European Hospital, Via Portuense
🇮🇹Roma, RM, Italy
Instituto Mexicano del Seguro Social (IMSS)
🇲🇽Ciudad de México, Mexico
Medical University of Silesia
🇵🇱Katowice, Poland
Unidade Local de Saude Lisboa Ocidental (ULSLO)
🇵🇹Lisboa, Portugal
Dedinje Cardiovascular Institute
🇷🇸Belgrade, Serbia
Hospital Clinic de Barcelona (ICCV)
🇪🇸Barcelona, L'Eixample, Spain
Hospital del Vinalopó
🇪🇸Alicante, Spain
Hospital Universitario de Navarra
🇪🇸Pamplona, Spain