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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
650
Aalborg University Hospital
Aalborg, Denmark
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark
All cause death, myocardial infarction or revascularization
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
Time frame: 1 year
Cardiac death or myocardial infarction
Time frame: 1 year
Hospitalization for acute coronary syndrome or acute heart failure
Time frame: 1 year
Angina status and quality of life
Time frame: 1 year
Infarct size in relation to area at risk as determined by MRI
Time frame: 3 months
Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions
Time frame: 2 years
Wall motion index (WMI) determined by echocardiography
Time frame: 1 year
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