FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease (SLIM)
Coronary Artery Disease, NSTEMI - Non-ST Segment Elevation MI, Fractional Flow Reserve, Myocardial
About this trial
This is an interventional treatment trial for Coronary Artery Disease
Eligibility Criteria
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
Sites / Locations
- Brno University HospitalRecruiting
- Gottsegen György Országos Kardiológiai IntézetRecruiting
- Bacs-Kiskun Teaching HospitalRecruiting
- Szeged UniversityRecruiting
- Jeroen Bosch ZiekenhuisRecruiting
- Zuyderland MCRecruiting
- Maastricht University Medical CentreRecruiting
- Viecuri Medisch CentrumRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ischemia driven revascularization
Usual care group
In the ischemia driven complete revascularisation strategy group all flow limiting (FFR ≤ 0.80) lesions will receive treatment by PCI and stenting. The non-IRA PCI should be performed during the same intervention. Exceptions can be made for complex lesions where the operator estimates that the revascularisation procedure will require significant contrast overload, which may lead to deterioration of cardiac and renal function of the patient.
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.