Myocardial Infarction
Conditions
Keywords
non-STEMI, immediate, delayed, PCI
Brief summary
In patients with acute myocardial infarction without ST-segment elevation on ECG (non-STEMI), previous studies have indicated that routine invasive treatment confers more benefit as compared to selective invasive approach. The benefits of routine invasive coronary intervention have been the most evident in patients with higher baseline risk profile. However, the question of optimal timing of routine invasive intervention remains unsolved. Immediate invasive intervention early after admission for non-STEMI may limit myocardial necrosis by securing the patency of the culprit coronary artery. Nevertheless, several previous studies reported higher levels of biomarkers of myocardial injury in patients undergoing early PCI. The question of earlier versus delayed procedure in non-STEMI patients may thus amount to whether the risk of intervening on an unstable plaque is greater than the risk of new ischemic events while waiting for the invasive procedure. The purpose of the present study is to compare effects of immediate coronary intervention, within 2 hours of admission, versus delayed intervention, within 2-72 hours after admission, in patients witn non-STEMI.
Interventions
PROCEDUREImmediate invasive intervention
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery as soon as possible and/or within 2 hours of admission
PROCEDUREDelayed invasive intervention
Invasive coronary angiography followed by either percutaneous coronary intervention (PCI) and/or coronary artery bypass graft (CABG) surgery during the hospitalization and/or within 2-72 hours of admission
DEVICECoronary artery stenting
Implantation of coronary stents
Sponsors
Clinical Centre of Serbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. episode of chest pain occurring no longer than 24 hours prior to admission 2. elevation of cardiac troponin I above the upper limit of normal (ULN) 3. new ST-segment depression at least 1 millivolt (mV) and/or T-wave inversion or transient ST-segment elevation in ≥ 2 contiguous leads
Exclusion criteria
1. age \< 18 years 2. persistent ST-segment elevation 3. hemodynamic instability 4. cardiogenic shock on admission 5. life-threatening ventricular arrhythmias on admission 6. refractory angina on admission 7. active bleeding 8. any contraindication for the use of dual antiplatelet therapy (DAPT) 9. presence of comorbidities with life expectancy \< 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of all-cause death or myocardial reinfarction | within 30 days of randomization |
Secondary
| Measure | Time frame |
|---|---|
| All-cause mortality | within 30 days, 1, 3 and 5 years after randomization |
| Myocardial reinfarction | within 30 days, 1, 3 and 5 years after randomization |
| Stroke | within 30 days, 1, 3 and 5 years after randomization |
| Composite of all-cause death, myocardial reinfarction or recurrent ischemia | within 30 days of randomization |
| Major bleeding | within 30 days, 1, 3 and 5 years after randomization |
| Duration of index hospitalization | at 30-day follow-up, the duration of hospital stay is assessed |
| Recurrent ischemia | within 30 days of randomization |
Countries
Serbia
Outcome results
None listed