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

NCT ID: NCT03562572

Last Updated: 2025-08-15

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 476 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-07
• Study Completion Date: 2027-07-31

Brief Summary

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

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ischemia driven revascularization

Intervention Type: 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

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.

Group Type: ACTIVE_COMPARATOR

Usual care group

Intervention Type: 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.

Interventions

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

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maastricht University Medical Center

OTHER

Sponsor Role: collaborator

Radboud University Medical Center

OTHER

Sponsor Role: collaborator

Jeroen Bosch Ziekenhuis

OTHER

Sponsor Role: collaborator

VieCuri Medical Centre

OTHER

Sponsor Role: collaborator

Gottsegen György Országos Kardiológiai Intézet

UNKNOWN

Sponsor Role: collaborator

Bács-Kiskun County Teaching Hospital

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: collaborator

Szeged University

OTHER

Sponsor Role: collaborator

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Saman Rasoul

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saman Rasoul, Dr.

Role: PRINCIPAL_INVESTIGATOR

Zuyderland MC

Arnoud van 't Hof, Prof. Dr.

Role: STUDY_DIRECTOR

Zuyderland MC

Locations

Brno University Hospital

Brno, , Czechia

Gottsegen György Országos Kardiológiai Intézet

Budapest, , Hungary

Bacs-Kiskun Teaching Hospital

Kecskemét, , Hungary

Szeged University

Szeged, , Hungary

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

Zuyderland MC

Heerlen, , Netherlands

Maastricht University Medical Centre

Maastricht, , Netherlands

Radboud University Medical Centre

Nijmegen, , Netherlands

Viecuri Medisch Centrum

Venlo, , Netherlands

Countries

Czechia; Hungary; Netherlands

References

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 Aug 31:e2516189. doi: 10.1001/jama.2025.16189. Online ahead of print.

Reference Type: DERIVED

PMID: 40886310 (View on PubMed)

Other Identifiers

28708

Identifier Type: OTHER

Identifier Source: secondary_id

17-T-142

Identifier Type: -

Identifier Source: org_study_id