Last updated 3 months ago
The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
754 patients around the world
Available in Spain, Brazil, United States
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.
Sunnybrook Health Sciences Centre
1Research sites
754Patients around the world
This study is for people with
Cardiomyopathy
Ischemic cardiomyopathy
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- 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.
- 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.Failure to provide informed consent.
Sites
Instituto de Cardiologia
Recruiting
SponsorSunnybrook Health Sciences Centre
Study typeInterventional
Conditions
Ischemic cardiomyopathy
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT05427370
