The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSunnybrook Health Sciences Centre
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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);
Trial design
Design model
Parallel
Treatments tested in this trial
Revascularization by PCI
Procedure/SurgeryContemporary, "State-of-the-art" PCI techniques will be encouraged in STICH3C, based on the most recent evidence and clinical practice guidelines recommendations. The best practices to be followed include the use of physiological and intravascular guidance, new-generation drug-eluting stents or scaffolds, rotational or orbital atherectomy for extensive calcifications, recommended bifurcation techniques, chronic total occlusion for viable segments by experienced operators, and trans-radial access.Planned temporary ventricular support is permitted by experienced operators when deemed indicated.
Revascularization by CABG
Procedure/SurgeryThe surgical revascularization strategy will be tailored according to the individual patient's coronary anatomy, left ventricular remodeling, aortic atherosclerosis, co-morbidities, local expertise, and surgical judgement. An internal thoracic artery will be used to graft the left anterior descending in all cases. Multi-arterial grafting may be considered in patients without significant co-morbidities and with expected limited vasopressor use, or in patients without saphenous conduits. Choice of on- vs. off-pump surgery is influenced by LV size, associated valvular disease, and aortic atherosclerosis, as well as surgeon experience, but on-pump surgery is recommended routinely. The use of adjunctive intra-aortic balloon support or other cardiac support is not routinely recommended in stable patients; the intra-aortic balloon support is the first line mechanical support.
Treatment groups
754 Participants
are divided into 2 treatment groupsGroup A: Revascularization by PCIExperimental treatment 1 intervention
Group B: Revascularization by CABGExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The Primary outcome is a Composite of all-cause mortality, stroke, spontaneous myocardial infarction, urgent repeat revascularization or heart failure readmission.
Time to event outcome measured as the time from randomization to the occurence of the first event.
Time frame
Median follow-up of 5 years.Secondary outcomes
1
Death
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.
Time frame
At 30 days , 90 days and through study completion with a median follow-up of 5 years.2
Myocardial Infarction (MI)
Periprocedural/perioperative MI is defined as \<48 hours from revascularization. Spontaneous MI is defined as \> or = 48 hours post revascularization
Time frame
At 30 days and through study completion with a median follow-up of 5 years.3
Number of participants with Stroke
Strokes will be classified as ischemic, hemorrhagic or uncertain.
Time frame
At 30 days , 90 days and through study completion with a median follow-up of 5 years.4
Repeat Revascularization (RR)
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.
Time frame
At 30 days , 90 days and through study completion with a median follow-up of 5 years.Other outcomes
1
Kansas City Cardiomyopathy Questionnaire-12
The scores range from 0-100 with higher scores indicating higher quality of life. The scores are classified as 0 to 24: very poor to poor; 25 to 49: poor to fair; 50 to 74: fair to good; and 75 to 100: good to excellent.
Time frame
Through study completion with a median follow-up of 5 years.2
Seattle Angina Questionnaire-7
It generates a summary score (scale 0-100, 100 = full health, 0 = worst health).
Time frame
Through study completion with a median follow-up of 5 years.3
Short Form 12 Questionnaire
Scores range from 0 to 100, with higher scores indicating better physical and mental health functioning.
Time frame
Through study completion with a median follow-up of 5 years.4
EuroQol-5D (EQ-5D)
Each dimension in the EQ-5D-5L has five response levels: no problems (Level 1); slight; moderate; severe; and extreme problems (Level 5). The EQ-5D index score is anchored at 1 (full health) and 0 (death).
Time frame
Through study completion with a median follow-up of 5 years.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Sunnybrook Health Sciences Centre
Lead sponsor
Canadian Institutes of Health Research (CIHR)
Collaborator
Weill Medical College of Cornell University
Collaborator
Source ClinicalTrials.gov