Acute Myocardial Infarction, Coronary Artery Disease
Conditions
Keywords
STEMI, ticagrelor, multi-vessel disease, culprit lesion
Brief summary
To determine whether, on a background of optimal medical therapy, including ticagrelor, opening of all suitable narrowings or blockages found at the time of primary PCI for an acute heart attack is better than treating only the culprit lesion in patients with multi-vessel disease.
Detailed description
To determine if a strategy of multivessel revascularization involving PCI of all suitable non-infarct related artery lesions plus optimal medical therapy is superior to a strategy of optimal medical therapy alone in reducing (1) the composite outcome of cardiovascular (CV) death or new myocardial infarction (MI), or (2) the composite of CV death, new MI or ischemia driven revascularization (IDR) in patients with multivessel disease who have undergone early successful culprit lesion PCI for STEMI.
Interventions
PROCEDUREComplete Revascularization Strategy
Staged PCI using second generation drug eluting stents (Promus Element Plus drug-eluting stent or newer version in this series is strongly recommended) of all suitable non-culprit lesions plus optimal medical therapy.
Sponsors
Population Health Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Men and women within 72 hours after successful PCI (preferably using a drug eluting stent) to the culprit lesion for STEMI. PCI for STEMI can be either primary PCI or rescue PCI for failed fibrinolysis or a combination strategy where PCI is performed routinely 3-12 hours after fibrinolysis AND 2. Multi-vessel disease defined as at least 1 additional non-infarct related coronary artery lesion that is at least 2.5 mm in diameter that has not been stented as part of the primary PCI and that is amenable to successful treatment with PCI and has: * At least 70% diameter stenosis (visual estimation) or * At least 50% diameter stenosis (visual estimation) with fractional flow reserve (FFR) ≤ 0.80
Exclusion criteria
1. Planned revascularization of non-culprit lesion 2. Planned surgical revascularization 3. Non-cardiovascular co-morbidity reducing life expectancy to \< 5 years 4. Any factor precluding 5 year follow-up 5. Prior Coronary Artery Bypass Graft (CABG) Surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of Cardiovascular death or new myocardial Infarction | over duration of follow-up (average of approximately 4 years) | Co-primary outcome: CV death or new MI |
| Composite of cardiovascular death, new myocardial infarction or ischemia-driven revascularization | over duration of follow-up (average of approximately 4 years) | Co-primary outcome: CV death, new MI or IDR |
Secondary
| Measure | Time frame |
|---|---|
| Composite of CV death, new MI, ischemia-driven revascularization or hospitalization for unstable angina or heart failure | Over duration of follow-up (average of approximately 4 years) |
Other
| Measure | Time frame |
|---|---|
| Major Bleeding | Over duration of follow-up (average of approximately 4 years) |
Countries
Canada
Outcome results
None listed