ST-elevation Myocardial Infarction, Multi Vessel Disease
Conditions
Keywords
STEMI, MVD, Full revascularization, Culprit lesion revascularization only, Primary PCI
Brief summary
In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.
Detailed description
STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR). Eligible coronary arteries must be \>2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses \> 50% can be randomized. All randomized lesions with diameter stenosis \> 50% and \< 90% are evaluated by FFR and a FFR value \< 0.80 is considered significant and treated. Stenoses \>90% are treated without prior FFR. Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.
Interventions
PROCEDUREPercutaneous coronary intervention
PROCEDUREFFR
Sponsors
Aalborg University Hospital
Rigshospitalet, Denmark
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Acute onset of chest pain of \< 12 hours' duration. * ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block. * Culprit lesion in a major native vessel. * MVD (non-culprit vessels with angiographic stenosis \>50%) * Successful primary PCI
Exclusion criteria
* Pregnancy. * Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast. * Inability to understand information or to provide informed consent. * Haemorrhagic diathesis or known coagulopathy. * Stent thrombosis * Significant left main stem stenosis * Cardiogenic shock at admittance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All cause death, myocardial infarction or revascularization | 1 year | Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure |
Secondary
| Measure | Time frame |
|---|---|
| Hospitalization for acute coronary syndrome or acute heart failure | 1 year |
| Angina status and quality of life | 1 year |
| Cardiac death or myocardial infarction | 1 year |
| Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions | 2 years |
| Wall motion index (WMI) determined by echocardiography | 1 year |
| Infarct size in relation to area at risk as determined by MRI | 3 months |
Countries
Denmark
Outcome results
None listed