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

Overview

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 1, 2022

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.

Interventions

  • 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
  • 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.

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The incidence of MACE at 12 months
    • Time Frame: 12 months
    • MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.

Secondary Measures

  • The incidence of MACE in subgroups at 12 and 24 months.
    • Time Frame: 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.
  • 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.
    • Time Frame: 12, 24 and 36 months
  • Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.
    • Time Frame: 12, 24 and 36 months
  • All-cause mortality or Myocardial infarction at 12, 24 and 36 months.
    • Time Frame: 12, 24 and 36 months
  • Any revascularisation at 12, 24 and 36 months.
    • Time Frame: 12, 24 and 36 months
  • Stent thrombosis at 12, 24 and 36 months.
    • Time Frame: 12, 24 and 36 months
  • Bleeding (major and minor) at 48 hours and 12 months.
    • Time Frame: 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.
    • Time Frame: 12, 24 and 36 months
    • MACE = The composite endpoint of all cause death, non-fatal Myocardial Infarction, any revascularisation and stroke at 12 months.
  • Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).
    • Time Frame: 12, 24 and 36 months

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 85 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Zuyderland Medisch Centrum
  • Collaborator
    • Maastricht University Medical Center
  • Provider of Information About this Clinical Study
    • Principal Investigator: Saman Rasoul, Principal Investigator – Zuyderland Medisch Centrum
  • Overall Official(s)
    • Saman Rasoul, Dr., Principal Investigator, Zuyderland MC
    • Arnoud van ‘t Hof, Prof. Dr., Study Director, Zuyderland MC
  • Overall Contact(s)
    • Tobias Pustjens, Drs., +31884597777, t.pustjens@gmail.com

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