Ffr-gUidance for compLete Non-cuLprit REVASCularization

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

Randomization and data collection in the registries - the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) and corresponding registries in other countries (or electronic data capture) - will ensure low bias, high inclusion rate and excellent follow-up of events at a low cost. Adjudication of clinical events and collection of data from other registries including death cause registries is also planned.

Significance: If this study shows that FFR-guided PCI of non-culprit lesions in STEMI/very high risk NSTEMI improves clinical outcome compared to conventional management this will change practise in how we should best manage these patients. Therefore a study of this size will definitely be of great importance in determining future guidelines for this large patient group to reduce both morbidity and mortality.

Conditions

• Coronary Artery Disease
• ST-elevation Myocardial Infarction

Interventions

PROCEDURE

FFR Treatment Arm

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

OTHER

Conservative Treatment Arm

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

Sponsors & Collaborators

• Uppsala University

  collaborator OTHER

• The Swedish Research Council

  collaborator OTHER_GOV

• Swedish Heart Lung Foundation

  collaborator OTHER

• Abbott

  collaborator INDUSTRY

• Boston Scientific Corporation

  collaborator INDUSTRY

• Felix Bohm

  lead OTHER

Principal Investigators

• Felix Bohm, MD, PhD · Karolinska Institutet

• Stefan James, Professor · Uppsala University, Sweden

• Andreas Rück, MD, PhD · Karolinska University Hospital

• Thomas Engstrøm, MD, PhD · Rigshospitalet, Denmark

• Mika Laine, MD, PhD · Helsinki University Hospital, Finland

• Andrejs Erglis, Professor · Riga, Latvia

• Goran Stankovic, Professor · Belgrade, Serbia

• Carl Schultz, Professor · Perth, Australia

• Madhav Menon, MD, PhD · Hamilton, New Zealand

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-08-08

Primary Completion

2023-07-17

Completion

2023-07-17

Countries

• Sweden

Study Locations