Ffr-gUidance for compLete Non-cuLprit REVASCularization

NCT02862119 | Completed DMC

• 1 other identifier: FULL REVASC
• Study Type: interventional
• Target: 1,542
• Locations: 1 country
• Sites: 1

Brief Summary

Background: The best strategy for ST-elevation myocardial infarction (STEMI) patients with multi-vessel disease, who undergo primary percutaneous coronary intervention (PCI) of the infarct-related artery (IRA) in the acute phase with remaining multivessel disease, is still not well established. Current guidelines recommend PCI of only the infarct related artery (IRA). However, recent small scale randomised controlled trials indicate that full revascularization of these non-infarct related arteries during the index procedure is superior to initial conservative treatment. Fractional flow reserve (FFR), a method used to determine ischemia-inducing lesions, has been shown to be superior to angiography-guided PCI in stable angina. Objective and methods: To test the hypothesis that a strategy of systematic complete revascularization with FFR-guided PCI following STEMI/very high risk NSTEMI leads to improved clinical outcomes compared to initial conservative management of non-culprit lesions. The trial is a prospective international multicentre registry-based randomized controlled trial with combined primary endpoint of all-cause mortality, or non-fatal MI, or unplanned revascularization at a minimum follow-up of 2-3 years. The first key secondary endpoint is the combined endpoint of all-cause mortality or myocardial infarction. The second key secondary endpoint is unplanned revascularization. 1542 patients with acute STEMI/very high risk NSTEMI with multi-vessel disease in Sweden, Denmark, Serbia, Finland, Latvia, Australia and New Zealand will be randomized into 2 arms:

1. 1.FFR-guided PCI of non-culprit lesions during index hospital admission or
2. 2.Initial conservative management following acute PCI of the culprit lesion(s) or

Conditions

Coronary Artery Disease; ST-elevation Myocardial Infarction

Keywords

percutaneous coronary intervention; fractional flow reserve; all cause mortality; myocardial infarction; registry-based randomized clinical trial

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of all-cause mortality, or myocardial infarction, or unplanned revascularization.

  Combined endpoint of all-cause mortality, or myocardial infarction, or unplanned revascularization during a minimum follow-up of 2-3 years.

  Minimum 2-3 years

Secondary Outcomes (15)

• Combined endpoint of all-cause mortality, or myocardial infarction.

  Minimum 2-3 years.

• Number of patients with unplanned revascularization (PCI/CABG) of the coronary arteries

  Minimum 2-3 years.

• Combined end point of all-cause mortality, MI, and unplanned revascularization (PCI/CABG) at a minimum follow-up of 2-3 years in pre-specified subgroups

  Minimum 2-3 years.

• All-cause mortality

  Minimum 2-3 years.

• Myocardial infarction (fatal and non-fatal)

  Minimum 2-3 years.

Other Outcomes (7)

• Contrast volume

  1 month

• X-ray duration

  1 month

• Neurological complications

  1 month

Study Arms (2)

FFR Treatment Arm

EXPERIMENTAL

Following PCI of the infarct related artery it is up to the PCI operator to perform FFR-guided PCI of non-infarct related lesion(s) during the index procedure or later during the index hospital admission. For stenosis grade 90-99% FFR is not mandatory (but recommended). An FFR value of ≤0.80 is to be considered significant for ischemia with a recommendation that non-culprit PCI is performed. It is up to the operator to decide whether to use intra-venous or intracoronary adenosine during FFR. An FFR of \>0.80 is to be considered non-significant for ischemia with a recommendation that medical management is pursued. Pressure wires: Only Fractional Flow Reserve pressure wires from St Jude Medical or Boston Scientific can be used in this study.

Procedure: FFR Treatment Arm

Conservative Treatment Arm

ACTIVE COMPARATOR

Only the infarct-related artery will be treated with PCI in this treatment arm during the index hospital admission. Medical therapy for angina pectoris is at the investigators discretion. Clinical follow-up of symptoms is recommended, but it is also acceptable to make a plan at hospital discharge for a later outpatient non-invasive stress-test. It is not acceptable to plan for an elective PCI in this treatment arm without signs of ischemia or symptoms.

Other: Conservative Treatment Arm

Interventions

FFR Treatment Arm PROCEDURE

Fractional Flow Reserve-guided PCI of non-culprit lesions during index hospital admission

FFR Treatment Arm

Conservative Treatment Arm OTHER

Initial Conservative management of non-culprit lesions during index hospital admission

Conservative Treatment Arm

Eligibility Criteria

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

You may qualify if:

• The following specific criteria must be fulfilled:
• Symptoms indicating acute myocardial ischemia with a duration \>30 min and occurring ≤ 24 h prior to randomization or presentation.
• One of the following:
• STEMI: ST elevation above the J-point of ≥0.1 millivolt in ≥ two contiguous leads or left bundle branch block
• Rescue PCI
• Risk evaluation following successful thrombolysis
• Very high risk NSTEMI: dynamic ECG changes or ongoing chest pain or acute heart failure or hemodynamic instability independent of ECG changes or life-threatening ventricular arrhythmias.
• PCI performed of infarct-related artery.
• One or more non-culprit lesions at least 2.5 mm on angiogram (visually assessed as 50-99%) amenable for PCI.
• Age \>18 years.
• Ability to provide informed consent.

You may not qualify if:

• Previous CABG.
• Left main disease of \>50% stenosis requiring intervention.
• Cardiogenic shock necessitating therapy in addition to revascularization. (LV support device or vasopressors).

Sponsors & Collaborators

• Felix Bohm: lead
• Uppsala University: collaborator
• The Swedish Research Council: collaborator
• Swedish Heart Lung Foundation: collaborator
• Abbott: collaborator
• Boston Scientific Corporation: collaborator

Study Sites (1)

Karolinska University Hospital

Stockholm, S-171 76, Sweden

Location

Related Publications (3)

• Bohm F, Mogensen B, Engstrom T, Stankovic G, Srdanovic I, Lonborg J, Zwackman S, Hamid M, Kellerth T, Lauermann J, Kajander OA, Andersson J, Linder R, Angeras O, Renlund H, Erglis A, Menon M, Schultz C, Laine M, Held C, Ruck A, Ostlund O, James S; FULL REVASC Trial Investigators. FFR-Guided Complete or Culprit-Only PCI in Patients with Myocardial Infarction. N Engl J Med. 2024 Apr 25;390(16):1481-1492. doi: 10.1056/NEJMoa2314149. Epub 2024 Apr 8.

  PMID: 38587995 DERIVED

• Ong P, Martinez Pereyra V, Sechtem U, Bekeredjian R. Management of patients with ST-segment myocardial infarction and multivessel disease: what are the options in 2022? Coron Artery Dis. 2022 Sep 1;33(6):485-489. doi: 10.1097/MCA.0000000000001157. Epub 2022 Jul 11.

  PMID: 35811565 DERIVED

• Bohm F, Mogensen B, Ostlund O, Engstrom T, Fossum E, Stankovic G, Angeras O, Erglis A, Menon M, Schultz C, Berry C, Liebetrau C, Laine M, Held C, Ruck A, James SK. The Full Revasc (Ffr-gUidance for compLete non-cuLprit REVASCularization) Registry-based randomized clinical trial. Am Heart J. 2021 Nov;241:92-100. doi: 10.1016/j.ahj.2021.07.007. Epub 2021 Jul 24.

  PMID: 34310907 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; ST Elevation Myocardial Infarction; Myocardial Infarction

Condition Hierarchy (Ancestors)

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

Study Officials

• Felix Bohm, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

• Stefan James, Professor

  Uppsala University, Sweden

  STUDY CHAIR

• Andreas Rück, MD, PhD

  Karolinska University Hospital

  STUDY DIRECTOR

• Thomas Engstrøm, MD, PhD

  Rigshospitalet, Denmark

  STUDY DIRECTOR

• Mika Laine, MD, PhD

  Helsinki University Hospital, Finland

  STUDY DIRECTOR

• Andrejs Erglis, Professor

  Riga, Latvia

  STUDY DIRECTOR

• Goran Stankovic, Professor

  Belgrade, Serbia

  STUDY DIRECTOR

• Carl Schultz, Professor

  Perth, Australia

  STUDY DIRECTOR

• Madhav Menon, MD, PhD

  Hamilton, New Zealand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD, PhD, Interventional Cardiologist

Study Record Dates

• First Submitted: August 1, 2016
• First Posted: August 10, 2016
• Study Start: August 8, 2016
• Primary Completion: July 17, 2023
• Study Completion: July 17, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)