Clinical trial NCT03562572: FFR Driven Complete Revascularization Versus Usual Care in NSTEMI Patients and Multivessel Disease
Official title: 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: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
NSTEMI - Non-ST Segment Elevation MI
Fractional Flow Reserve, Myocardial
Myocardial Revascularization
Percutaneous Coronary Intervention
Lead sponsor: Zuyderland Medisch Centrum
Sponsor class: OTHER
Collaborators: name: Maastricht University Medical Center
name: Radboud University Medical Center
name: Jeroen Bosch Ziekenhuis
name: VieCuri Medical Centre
name: Gottsegen György Országos Kardiológiai Intézet
name: Bács-Kiskun County Teaching Hospital
name: Brno University Hospital
name: Szeged University
First posted: 2018-06-19
Enrollment: 476
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The incidence of MACE at 12 months
timeFrame: 12 months
Secondary outcomes:
measure: The incidence of MACE in subgroups at 12 and 24 months.
timeFrame: 12 and 24 months
measure: 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.
timeFrame: 12, 24 and 36 months
measure: Composite endpoint hospitalisation for heart failure and unstable angina pectoris at 12, 24 and 36 months.
timeFrame: 12, 24 and 36 months
measure: All-cause mortality or Myocardial infarction at 12, 24 and 36 months.
timeFrame: 12, 24 and 36 months
measure: Any revascularisation at 12, 24 and 36 months.
timeFrame: 12, 24 and 36 months
measure: Stent thrombosis at 12, 24 and 36 months.
timeFrame: 12, 24 and 36 months
measure: Bleeding (major and minor) at 48 hours and 12 months.
timeFrame: 48 hours and 12 months
measure: The incidence of MACE at 36 months as well as outcomes of each component of MACE at 12 and 24 and 36 months.
timeFrame: 12, 24 and 36 months
measure: Left ventricular ejection fraction at 12 and 24 and 36 month (MIBI scan, MRI or Echocardiography).
timeFrame: 12, 24 and 36 months
Other outcomes:
Locations:
city: Brno
country: Czechia
facility: Brno University Hospital
city: Budapest
country: Hungary
facility: Gottsegen György Országos Kardiológiai Intézet
city: Kecskemét
country: Hungary
facility: Bacs-Kiskun Teaching Hospital
city: Szeged
country: Hungary
facility: Szeged University
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland MC
city: Maastricht
country: Netherlands
facility: Maastricht University Medical Centre
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Centre
city: Venlo
country: Netherlands
facility: Viecuri Medisch Centrum
Study officials:
affiliation: Zuyderland MC
name: Saman Rasoul, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Zuyderland MC
name: Arnoud van 't Hof, Prof. Dr.
role: STUDY_DIRECTOR
References: