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

NCT03562572 | Active Not Recruiting DMC

• 2 other identifiers: 17-T-14228708
• Study Type: interventional
• Target: 476
• Locations: 3 countries
• Sites: 9

Brief Summary

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• The incidence of MACE in subgroups at 12 and 24 months.

  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

Study Arms (2)

Ischemia driven revascularization

EXPERIMENTAL

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

Usual care group

ACTIVE COMPARATOR

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

Interventions

Ischemia driven revascularization PROCEDURE

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

Ischemia driven revascularization

Usual care group OTHER

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.

Usual care group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead
• Maastricht University Medical Center: collaborator
• Radboud University Medical Center: collaborator
• Jeroen Bosch Ziekenhuis: collaborator
• VieCuri Medical Centre: collaborator
• Gottsegen György Országos Kardiológiai Intézet: collaborator
• Bács-Kiskun County Teaching Hospital: collaborator
• Brno University Hospital: collaborator
• Szeged University: collaborator

Study Sites (9)

Brno University Hospital

Brno, Czechia

Location

Gottsegen György Országos Kardiológiai Intézet

Budapest, Hungary

Location

Bacs-Kiskun Teaching Hospital

Kecskemét, Hungary

Location

Szeged University

Szeged, Hungary

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, Netherlands

Location

Zuyderland MC

Heerlen, Netherlands

Location

Maastricht University Medical Centre

Maastricht, Netherlands

Location

Radboud University Medical Centre

Nijmegen, Netherlands

Location

Viecuri Medisch Centrum

Venlo, Netherlands

Location

Related Publications (1)

• Pustjens TFS, Veenstra L, Camaro C, Ruiters AW, Lux A, Ruzsa Z, Piroth Z, Ilhan M, Vainer J, Gho B, Winkler PJC, Stein M, Theunissen RALJ, Kala P, Polad J, Berta B, Gabrio A, van Royen N, van 't Hof AWJ, Rasoul S. Fractional Flow Reserve-Guided Complete vs Culprit-Only Revascularization in Non-ST-Elevation Myocardial Infarction and Multivessel Disease: The SLIM Randomized Clinical Trial. JAMA. 2025 Nov 11;334(18):1628-1637. doi: 10.1001/jama.2025.16189.

  PMID: 40886310 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Study Officials

• Saman Rasoul, Dr.

  Zuyderland MC

  PRINCIPAL INVESTIGATOR

• Arnoud van 't Hof, Prof. Dr.

  Zuyderland MC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: It concerns an investigator initiated prospective 1:1 randomised clinical trial in non-STEMI patients with multivessel coronary artery disease amenable to treatment with PCI.

Study Record Dates

• First Submitted: May 23, 2018
• First Posted: June 19, 2018
• Study Start: June 7, 2018
• Primary Completion: July 21, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: August 15, 2025

Record last verified: 2025-08

Locations

HU (3); CZ (1); NL (5)