Comparison Between FFR Guided Revascularization Versus Conventional Strategy in Acute STEMI Patients With MVD.
Condition: Myocardial Infarction; Multivessel Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Infarction; Infarction
Study type: Interventional

Summary: 
      The Compare-Acute trial is a prospective randomised trial in patients with multivessel
      disease, who are admitted into hospital with a ST-elevation Myocardial Infarction. The
      purpose of the study is to compare a FFR guided multivessel PCI taking place during the
      primary PCI with a primary PCI of the culprit vessel only.

      Patients will be enrolled after successful revascularisation of the culprit vessel. Patients
      that have at least one lesion with a diameter of stenosis of more than 50% on visual
      estimation, feasible (operators judgement) for treatment with PCI in a non-infarct related
      artery, will be randomised either to the FFR guided complete revascularisation arm or staged
      revascularisation by proven ischemia or persistence of symptoms of angina.

      Approximately 885 patients will be entered in the study.

      Study hypothesis: 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.
    

Detailed description: 
      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
    

Intervention name(s): FFR-guided revascularisation strategy; randomised to guidelines group
Intervention type(s): Procedure; Procedure
Intervention description(s): FFR-guided revascularisation strategy; Staged revascularisation by proven ischemia or persistence of symptoms of angina
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCI FFR STEMI MVD; FFR guided PCI in acute STEMI patients with MVD