Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Unity Health Toronto
- Enrollment
- 3,520
- Primary Endpoint
- Major adverse clinical events
Study Overview
Brief Summary
This study is being conducted in patients with a major heart attack caused by a blocked artery undergoing Percutaneous Coronary Intervention (PCI) to open up the blockage. Up to 50% of people with an heart attack are found to have one or more additional narrowings that did not cause the heart attack. At present the best way to manage these additional blockages is not known. Many cardiologist recommend opening these blockages at at a later time after the heart attack. The present study is examining if PCI of all blockages at the same time as the PCI for the artery that caused the major heart attack (SS-PCI) will reduce the amount of heart damage compared to performing PCI of additional blockages 2-45 days later (IRA-PCI). Clinical follow up will be completed at 3, 12 and 24 months to determine heart function and monitor adverse events.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •ST elevation myocardial infarction evidenced by new ST elevation at the J point in at least 2 contiguous leads of ≥ 2 mm (0.2mV) in men or ≥ 1.5mm (0.15mV) in women in leads V2-V3 and/or ≥ 1mm (0.1mV) in other contiguous chest leads or limb leads.
- •MVD as evidenced by > one significant (>70% by visual assessment or FFR < 0.80 for 50-70% stenosis) stenosis in the non-IRA >2mm in diameter.
- •Successful IRA-PCI with <30% residual angiographic stenosis and TIMI III flow
- •Written informed consent
Exclusion Criteria
- •Age ≤ 18 years
- •Prior coronary artery bypass graft (CABG) surgery
- •Administration of thrombolytic therapy.
- •Hemodynamic instability as evidenced by SBP<90 mmHg, Killip class ≥3, and/or need for inotropes/vasopressors.
- •Known renal insufficiency (estimated GFR < 30 ml/min/1.73m2)
- •Non-IRA stenosis is a chronic total occlusion (CTO)
- •Plan by treating physician to treat non-IRA stenosis with coronary artery bypass surgery
Arms & Interventions
Same sitting complete revascularization
After treatment of the IRA, subjects will undergo PCI of all suitable significant non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm).
Intervention: Same sitting PCI with complete revascularization (Procedure)
Staged non-IRA PCI
Only the IRA will be intervened upon during the index primary PCI procedure. Staging of the non-IRA lesions will be performed 48 hours to 45 days after the primary PCI procedure. All suitable non-IRA lesions (≥70% by visual assessment or FFR<0.80 in 50-70% lesions with vessel diameter >2mm) will be treated with PCI irrespective of whether there are clinical symptoms or evidence of ischemia.
Intervention: Staged PCI with complete revsacularization >48 hours pf primary PCI (Procedure)
Outcomes
Primary Outcomes
Major adverse clinical events
Time Frame: 90 days
Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
Secondary Outcomes
- Heart failure(90 days)
- Major bleeding(90 days)
- Stroke(90 days)
- Contrast nephropathy(90 days)
- Major vascular complication(90 days)
- EQ-5D quality of life assessment(90 days)
- Myocardial infarction(90 days)
- All cause mortality(90 days)
- Unplanned revascularization(90 days)
- Incremental Cost-Effectiveness Ratio (ICER)(90 days)