Ischemia (FFR) Driven Complete Revascularization versus Usual Care in Patients with Non-ST Elevation Myocardial Infarction and Multivessel Diseases. The South Limburg Myocardial Infarction Study Group

Authors
Category Primary study
JournalOverview of Medical Research in the Netherlands
Year 2018
INTERVENTION: Patients will be enrolled and randomised in a 1:1 fashion between the ischemia driven (FFR) revascularisation strategy, versus usual care, after completion of a successful culprit lesion PCI. All patients who present at least with one lesion with a stenosis of approximately 50% or more in a non‐IRA with a diameter of = 2.0 mm and fulfil the inclusion and exclusion criteria will be enrolled. CONDITION: Coronary artery disease, Coronary artery disease, Non ST‐Elevation Acute Coronary Syndrome (NSTE‐ACS), Myocardial infarction , Multivessel Diseases ; ; PRIMARY OUTCOME: Primary study endpoints are defined as the incidence of MACE (Composite endpoint of all cause death, non‐fatal Myocardial Infarction, any revascularisation and stroke) at 12 months. SECONDARY OUTCOME: • Primary endpoint in subgroups at 12 and 24 months in the subgroup of patients. ; ; • Composite endpoint of Net Adverse Clinical Events (NACE) defined as composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and major bleeding at 12, 24 and 36 months. ; ; • Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months. ; ; • All‐cause mortality or Myocardial infarction at 12, 24 and 36 months.. ; ; • Any revascularisation at 12, 24 and 36 months. ; ; • Stent thrombosis at 12, 24 and 36 months. ; ; • Bleeding (major and minor) at 48 hr and 12 months ; ; • Primary endpoint at 36 months as well as outcomes of each component of the primary endpoint at 12 and 24 and 36 months. ; ; • Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography) ; INCLUSION CRITERIA: • Patients aged between 18‐85 years presenting with non‐STEMI according to current guidelines, who will be treated with PCI of the culprit and have at least one stenosis of >50% in a non‐IRA on QCA or visual estimation of baseline angiography and judged feasible for treatment with PCI by the operator. • Non‐IRA stenosis amenable for PCI treatment (operator’s decision) • Signed informed consent
Epistemonikos ID: c35d306de23368512f3512b923ca6bb1de4c05a2
First added on: Aug 24, 2024