Revascularization StrategIes for ST Elevation Myocardial Infarction Trial
- Conditions
- Primary AngioplastyCoronary StentingST Elevation Myocardial Infarction
- Interventions
- Procedure: Same sitting PCI with complete revascularizationProcedure: Staged PCI with complete revsacularization >48 hours pf primary PCI
- Registration Number
- NCT03263468
- Lead Sponsor
- Unity Health Toronto
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 3520
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Same sitting complete revascularization Same sitting PCI with 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). Staged non-IRA PCI Staged PCI with complete revsacularization >48 hours pf primary 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.
- Primary Outcome Measures
Name Time Method Major adverse clinical events 90 days Composite of all-cause mortality, myocardial infarction, heart failure and unplanned revascularization
- Secondary Outcome Measures
Name Time Method 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 Heart failure 90 days