Myocardial Infarction Clinical Trial
Official title:
Fractional Flow Reserve Guided Primary Multivessel Percutaneous Coronary Intervention to Improve Guideline Indexed Actual Standard of Care for Treatment of ST-elevation Myocardial Infarction in Patients With Multivessel Coronary Disease
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.
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
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