FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and 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.

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

Exclusion criteria

• Left main disease (stenosis > 50%)
• Chronic total occlusion of a non-IRA
• Indication for or previous coronary artery bypass grafting
• Uncertain culprit lesion
• Complicated IRA treatment, e.g. extravasation, permanent no re-flow after IRA treatment (TIMI flow 0-1) and inability to implant a stent
• Known severe cardiac valve dysfunction that will require surgery or TAVI in the follow-up period.
• Killip class III or IV during the completion of culprit lesion treatment.
• Life expectancy of < 1 year.
• Intolerance to Aspirin, Clopidogrel, Prasugrel, Ticagrelor or Heparin.
• Gastrointestinal or genitourinary bleeding within the prior 3 months.
• Planned elective surgical procedure necessitating interruption of thienopyridines during the first 6 months post enrolment.
• Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
• Pregnancy