The Canadian CABG or PCI in Patients With Ischemic Cardiomyopathy Trial (STICH3C)
- Conditions
- Coronary Artery DiseaseHeart Failure Systolic
- Registration Number
- NCT05427370
- Lead Sponsor
- Sunnybrook Health Sciences Centre
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 754
Inclusion Criteria:<br><br> 1. Age >18 years;<br><br> 2. LVEF =40% quantified by either echocardiography, SPECT ventriculography, or magnetic<br> resonance within 2 months of randomization;<br><br> 3. Prognostically important multivessel CAD (triple vessel CAD or double vessel disease<br> including the left anterior descending (LAD) or LM). Significant coronary stenosis<br> is defined as = 70% based on coronary angiography, and/or fractional flow reserve<br> (FFR) =0.80 or instantaneous wave-free ratio (iFR) =0.89. For LM disease,<br> significant coronary stenosis is defined as >50% based on coronary angiography,<br> intravascular ultrasound (IVUS) minimal luminal area (MLA) =6.0 mm2 (<4.5 mm2 Asian<br> descent), or equivalent optical coherence tomography (OCT) measurements;<br><br> 4. The institutional Heart Team agrees that guideline-directed medical therapy (GDMT)<br> has been initiated for =1 month in prevalent and newly diagnosed cases. In patients<br> hospitalized with newly diagnosed iLVSD (with or without acute coronary syndrome<br> (ACS)) requiring revascularization before discharge, GDMT needs to be initiated,<br> when possible in-hospital before randomization, with the expectation that it will be<br> titrated to maximally tolerated doses after revascularization.<br><br>Exclusion Criteria:<br><br> 1. Decompensated HF requiring inotropic/adrenergic support, invasive or non-invasive<br> ventilation or intra-aortic balloon pump/ventricular assist device therapy less than<br> 48 hours prior to randomization;<br><br> 2. Recent (<4 weeks) ST-elevation MI;<br><br> 3. Concomitant severe valvular disease or other condition such as left ventricular<br> aneurysm requiring surgical repair or replacement;<br><br> 4. Planned major concomitant surgical procedures (LAAO and AF ablation surgical<br> procedures permitted);<br><br> 5. Prior PCI within the past 12 months (to reduce restenosis events from prior PCIs<br> contributing to the primary outcome);<br><br> 6. Prior cardiac surgery;<br><br> 7. Prohibitive bleeding risk mandating avoidance of dual antiplatelet therapy;<br><br> 8. Circumstances likely to lead to poor treatment adherence;<br><br> 9. Severe end-organ dysfunction (such as dialysis, liver failure, respiratory failure,<br> cancer) that reduces life expectancy to less than 5 years;<br><br> 10. Current pregnancy;<br><br> 11. Patient not amenable to both CABG or PCI according to the Heart Team;<br><br> 12. Takotsubo/Takotsubo Cardiomyopathy/Broken Heart Syndrome;<br><br> 13. Failure to provide informed consent.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- 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.
- Secondary Outcome Measures
Name Time Method Heart Failure endpoint;Death;Myocardial Infarction (MI);Number of participants with Stroke;Repeat Revascularization (RR);Hospitalizations;Composite of death/stroke/spontaneous MI;Composite of death/stroke/spontaneous MI/RR;Composite of death or cardiac hospitalization;Coronary composite endpoint;Hierarchal Heart Failure outcome;Number of participants with advanced Heart failure therapies;Major Adverse Events