Clinical trial NCT05427370: The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Official title: The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Heart Failure Systolic
Keywords: Left ventricular dysfunction
CABG
PCI
MACCE
Lead sponsor: Sunnybrook Health Sciences Centre
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
name: Weill Medical College of Cornell University
First posted: 2022-06-22
Enrollment: 754
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The STICH3C trial is a prospective, unblinded, international multi-center randomized trial of comparing revascularization by PCI vs. CABG in patients with multivessel/LM CAD and reduced LVEF.
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
timeFrame: Median follow-up of 5 years.
Secondary outcomes:
measure: Death
timeFrame: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
measure: Myocardial Infarction (MI)
timeFrame: At 30 days and through study completion with a median follow-up of 5 years.
measure: Number of participants with Stroke
timeFrame: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
measure: Repeat Revascularization (RR)
timeFrame: At 30 days , 90 days and through study completion with a median follow-up of 5 years.
measure: Hospitalizations
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Composite of death/stroke/spontaneous MI
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Composite of death/stroke/spontaneous MI/RR
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Composite of death or cardiac hospitalization
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Coronary composite endpoint
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Heart Failure endpoint
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Hierarchal Heart Failure outcome
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Number of participants with advanced Heart failure therapies
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Major Adverse Events
timeFrame: 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.
Other outcomes:
measure: Kansas City Cardiomyopathy Questionnaire-12
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Seattle Angina Questionnaire-7
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Short Form 12 Questionnaire
timeFrame: Through study completion with a median follow-up of 5 years.
measure: EuroQol-5D (EQ-5D)
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Through study completion with a median follow-up of 5 years.
measure: Composite of severe stroke/ventilator dependance/new onset or worsening heart failure/ nursing home admission/ or new onset dialysis
timeFrame: Reported at 1 and 5 years and as a cumulative incidence.
measure: Composite of stroke, nursing home admission and 3 or more non-elective admissions per 12 months
timeFrame: Reported at 1 and 5 years and as a cumulative incidence.
measure: Length of stay outcomes
timeFrame: Reported at 90 days, 1 year and 5 years - this is only for DAOH.
measure: Cumulative costs
timeFrame: 4 years.
measure: Cost-effectiveness
timeFrame: 4 years.
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai
state: California
city: Louisville
country: United States
facility: UofL Health, Inc
state: Kentucky
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Vienna
country: Austria
facility: Medical University of Vienna
city: São Paulo
country: Brazil
facility: Heart Institute, Medical School of the University of Sao Paulo_INCOR
city: Calgary
country: Canada
facility: University of Calgary; Libin Cardiovascular Institute
state: Alberta
city: Edmonton
country: Canada
facility: Mackenzie Health Sciences Center
state: Alberta
city: New Westminster
country: Canada
facility: Fraser Health; Royal Columbian Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Providence Health
state: British Columbia
city: Halifax
country: Canada
facility: Queen Elizabeth II Hospital
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton General Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Center, University Hospital
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional HC
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Center
state: Ontario
city: Toronto
country: Canada
facility: St. Michael's
state: Ontario
city: Toronto
country: Canada
facility: Toronto General Hospital
state: Ontario
city: Montréal
country: Canada
facility: Center Hospitalier Universitaire de Montreal
state: Quebec
city: Montréal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montréal
country: Canada
facility: Hospital Sacre-Coeur
state: Quebec
city: Québec
country: Canada
facility: Institut de Cardiologie Quebec (QC) - Laval
state: Quebec
city: Jilin
country: China
facility: Jilin Heart Hospital
state: Changchun
city: Shanghai
country: China
facility: Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
city: Sušak
country: Croatia
facility: Clinical Hospital Dubrava
state: Zagreb
city: Düsseldorf
country: Germany
facility: University Hospital Dusseldorf
city: Palayam
country: India
facility: G Kuppuswamy Naidu Memorial Hospital (GKNM)
state: Tamil Nadu
city: Roma
country: Italy
facility: European Hospital, Via Portuense
state: RM
city: Ciudad de México
country: Mexico
facility: Instituto Mexicano del Seguro Social (IMSS)
city: Katowice
country: Poland
facility: Medical University of Silesia
city: Lisboa
country: Portugal
facility: Unidade Local de Saude Lisboa Ocidental (ULSLO)
city: Belgrade
country: Serbia
facility: Dedinje Cardiovascular Institute
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona (ICCV)
state: L'Eixample
city: Alicante
country: Spain
facility: Hospital del Vinalopó
city: Pamplona
country: Spain
facility: Hospital Universitario de Navarra
Study officials:
affiliation: Sunnybrook Health Sciences Center, Toronto, Canada
name: Stephen Fremes, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
affiliation: Weill Medical College of Cornell University, USA
name: Mario Gaudino, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute, QC Canada
name: Jean L Rouleau, MD,PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montreal Heart Institute, QC Canada
name: Guillaume Maquis-Gravel, MD,MSc
role: PRINCIPAL_INVESTIGATOR
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