FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease (SLIM)

Zuyderland Medisch Centrum

Status: Active, not recruiting

Conditions: Coronary Artery Disease; NSTEMI - Non-ST Segment Elevation MI; Percutaneous Coronary Intervention; Myocardial Revascularization; Fractional Flow Reserve, Myocardial

Treatments: Other: Usual care group; Procedure: Ischemia driven revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT03562572

28708 (Other Identifier)

17-T-142

Details and patient eligibility

About

To compare FFR guided complete revascularization during the index procedure with usual care in non-STEMI patients with multivessel disease.

Full description

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.

Enrollment: 476 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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476 participants in 2 patient groups

Ischemia driven revascularization

Experimental group

Description:

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.

Treatment:

Procedure: Ischemia driven revascularization

Usual care group

Active Comparator group

Description:

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.

Treatment:

Other: Usual care group