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

Ischemia (FFR) Driven Complete Revascularization Versus Usual Care in Patients With Non-ST Elevation Myocardial Infarction and Multivessel Diseases: The South Limburg Myocardial Infarction Study Group The SLIM Study

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Percutaneous Coronary Intervention; NSTEMI - Non-ST Segment Elevation MI; Myocardial Revascularization; Fractional Flow Reserve, Myocardial
• Intervention / Treatment: Procedure: Ischemia driven revascularization; Other: Usual care group

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 476
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Czechia
  • Brno, Czechia
    • Brno University Hospital
• Hungary
  • Budapest, Hungary
    • Gottsegen György Országos Kardiológiai Intézet
  • Kecskemét, Hungary
    • Bacs-Kiskun Teaching Hospital
  • Szeged, Hungary
    • Szeged University
• Netherlands
  • Den Bosch, Netherlands
    • Jeroen Bosch Ziekenhuis
  • Heerlen, Netherlands
    • Zuyderland MC
  • Maastricht, Netherlands
    • Maastricht University Medical Centre
  • Nijmegen, Netherlands
    • Radboud University Medical Centre
  • Venlo, Netherlands
    • VieCuri Medisch Centrum

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ischemia driven revascularization; 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.	Procedure: Ischemia driven revascularization; 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
Active Comparator: Usual care group; 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.	Other: Usual care group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The incidence of MACE in subgroups at 12 and 24 months.	Prespecified subgroup analyses of primary outcomes will be performed for: Diabetic patients versus non-diabetic patients; Elderly (≥ 75 years) versus young patients (< 75 years); Male versus Female gender; High versus low risk patients according to GRACE Risk Score; 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.	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.		12, 24 and 36 months
Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.		12, 24 and 36 months
All-cause mortality or Myocardial infarction at 12, 24 and 36 months.		12, 24 and 36 months
Any revascularisation at 12, 24 and 36 months.		12, 24 and 36 months
Stent thrombosis at 12, 24 and 36 months.		12, 24 and 36 months
Bleeding (major and minor) at 48 hours and 12 months.		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.	12, 24 and 36 months
Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).		12, 24 and 36 months

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum
• Collaborators: Radboud University Medical Center; Maastricht University Medical Center; Brno University Hospital; Szeged University; VieCuri Medical Centre; Jeroen Bosch Ziekenhuis; Bács-Kiskun County Teaching Hospital; Gottsegen György Országos Kardiológiai Intézet
• Investigators: Principal Investigator: Saman Rasoul, Dr., Zuyderland MC; Study Director: Arnoud van 't Hof, Prof. Dr., Zuyderland MC

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2018
• Primary Completion (Actual): July 21, 2025
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: May 23, 2018
• First Submitted That Met QC Criteria: June 7, 2018
• First Posted (Actual): June 19, 2018

Study Record Updates

• Last Update Posted (Estimated): August 15, 2025
• Last Update Submitted That Met QC Criteria: August 11, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Myocardial Infarction; Ischemia; Non-ST Elevated Myocardial Infarction; Coronary Artery Disease
• Other Study ID Numbers: 17-T-142; 28708 (Other Identifier: NTR)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No