Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD. (CompareAcute)

• Composite endpoint of MACCE [ Time Frame: 12 months ]
  Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Cerebrovascular Events (MACCE) at 12 months between groups
  
  

• Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ]
  Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged or acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients with FFR positive lesion that received optimal medical treatment.
  
  
• Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ]
  Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving acute PCI treatment for FFR positive lesions in the non-IRA vs the subgroup of patients receiving staged PCI treatment for FFR positive lesions in the non-IRA
  
  
• Primary endpoint in subgroups [ Time Frame: 12, 24 and 36 months ]
  Primary endpoint rates at 12, 24 and 36 months in the subgroup of patients receiving staged PCI treatment for FFR negative lesions in the non-IRA vs the subgroup of patients not receiving PCI treatment for FFR negative lesions in the non-IRA.
  
  
• Composite endpoint of NACE [ Time Frame: 12, 24 and 36 months ]
  Composite endpoint of Cardiac death, Myocardial Infarction, any Revascularisation, Stroke and Major bleeding at 12, 24 and 36 months (NACE i.e. Net Adverse Clinical Events)
  
  
• Composite endpoint hospitalisation HF and UAP [ Time Frame: 12, 24 and 36 months ]
  A composite of hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months
  
  
• All cause mortality and MI [ Time Frame: 12, 24 and 36 months ]
  All cause mortality or Myocardial infarction at 12, 24 and 36 months
  
  
• Revascularisation [ Time Frame: 12, 24 and 36 months ]
  Any revascularisation at 12, 24 and 36 months
  
  
• Stent thrombosis [ Time Frame: 12, 24 and 36 months ]
  Stent thrombosis at 12, 24 and 36 months
  
  
• Bleeding [ Time Frame: 48 hour and 12 months ]
  Bleeding at 48 hr and 12 months
  
  
• Treatment costs [ Time Frame: 12, 24 and 36 months ]
  Treatment costs 12, 24 and 36 months
  
  
• Primary endpoint at 24 and 36 [ Time Frame: 12, 24 and 36 months ]
  Primary endpoint at 24 and 36 months as well as outcomes of each component of the primary endpoint at 12, 24 and 36 months.
  
  

Background of the study: At the moment the general opinion is divided over the way the non culprit lesions in patients presenting with STEMI should be treated. While the previous guidelines stead that these lesions should be treated in a second time ( ie not during the primary intervention) the actual guidelines do not touch this argument. The reason is that the studies where the previous guidelines were based are old. Meanwhile small sized randomised trials from EU region have proven favourable outcomes with NON infarct related artery during the primary procedure while registers (non randomised trials) from USA still recommend the staged treatment. For this reason we have decided to perform a randomised study to address this issue incorporating the state of the art diagnosis and treatment, as well as the new medical therapy and PCI techniques.

Objective of the study: FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Study design: Prospective, 1: 2 randomisation. FFR guided revascularisation during primary PCI (1) versus following actual guidelines (2)

Study population: All STEMI patients between 18-85 years who will be treated with primary PCI in < 12 h (more than 12 hr if persisting pain allowed) after the onset of symptoms and have at least one stenosis of >50% in a non-IRA judged feasible for treatment with PCI.

Intervention (if applicable): FFR-guided complete percutaneous revascularisation of all flow-limiting stenoses in the non-IRA performed within the same procedure as the primary PCI or within the same hospitalisation will improve clinical outcomes compared to the staged revascularisation, guided by prove of ischemia or clinical judgment, as recommended from the guidelines

Primary study parameters/outcome of the study: Composite endpoint of all cause mortality non-fatal Myocardial Infarction, any Revascularisation and Stroke (MACCE) at 12 months