To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.
Background: Patients with non-ST elevation myocardial infarction (non-STEMI), as compared with STEMI patients, have a higher risk profile, more often MVD and less favourable outcome. Recent studies showed that complete revascularization in STEMI patients is feasible and effective. However, there is no clear evidence regarding the role of complete coronary revascularization by PCI in patients with non-STEMI with MVD. Objective: To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease. Design: Prospective, multicentre, 1:1 randomized, investigator initiated study. Hypothesis: FFR guided complete percutaneous revascularisation of all significant stenosis in the non-culprit lesion performed within the index PCI procedure will improve clinical outcomes compared to the usual care, guided by discretion of the physician.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
476
In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting during the index intervention
In the randomised to usual care group the procedure will stop after the PCI of the culprit artery and the patient will be referred to his treating cardiologist and/ or heart team who will decide whether a staged PCI of the non- IRA artery should take place. If the treating cardiologist (after advise of the heart team) decides to perform the non-IRA PCI revascularisation, than such treatment should take place within six weeks from the primary PCI in order to count as a scheduled staged PCI procedure.
Brno University Hospital
Brno, Czechia
Gottsegen György Országos Kardiológiai Intézet
Budapest, Hungary
Bacs-Kiskun Teaching Hospital
Kecskemét, Hungary
Szeged University
Szeged, Hungary
The incidence of MACE at 12 months
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
Time frame: 12 months
The incidence of MACE in subgroups at 12 and 24 months.
Prespecified subgroup analyses of primary outcomes will be performed for: 1. Diabetic patients versus non-diabetic patients 2. Elderly (≥ 75 years) versus young patients (\< 75 years) 3. Male versus Female gender 4. High versus low risk patients according to GRACE Risk Score 5. Patients previous myocardial infarction versus patients with no previous myocardial infarction The Global Registry of Acute Coronary Events (GRACE) score estimates the admission 6 month mortality for patients with acute coronary syndrome. The GRACE score ranges from 0 to \> 285. A higher GRACE represents a higher mortality risk, ranging from 0-2% when the GRACE is between 0 and 87, to 99% when the GRACE exceeds 285.
Time frame: 12 and 24 months
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.
Time frame: 12, 24 and 36 months
Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.
Time frame: 12, 24 and 36 months
All-cause mortality or Myocardial infarction at 12, 24 and 36 months.
Time frame: 12, 24 and 36 months
Any revascularisation at 12, 24 and 36 months.
Time frame: 12, 24 and 36 months
Stent thrombosis at 12, 24 and 36 months.
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Jeroen Bosch Ziekenhuis
's-Hertogenbosch, Netherlands
Zuyderland MC
Heerlen, Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands
Radboud University Medical Centre
Nijmegen, Netherlands
Viecuri Medisch Centrum
Venlo, Netherlands
Time frame: 12, 24 and 36 months
Bleeding (major and minor) at 48 hours and 12 months.
Time frame: 48 hours and 12 months
The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months.
MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
Time frame: 12, 24 and 36 months
Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).
Time frame: 12, 24 and 36 months