Ffr-gUidance for compLete Non-cuLprit REVASCularization (FULL REVASC)
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|ClinicalTrials.gov Identifier: NCT02862119|
Recruitment Status : Active, not recruiting
First Posted : August 10, 2016
Last Update Posted : October 14, 2021
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 at one year 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 and non-fatal MI at one year. Key secondary endpoint is unplanned revascularization. 1545 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:
- FFR-guided PCI of non-culprit lesions during index hospital admission or
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Coronary Artery Disease ST-elevation Myocardial Infarction||Procedure: FFR Treatment Arm Other: Conservative Treatment Arm||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||4052 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ffr-gUidance for compLete Non-cuLprit REVASCularization - a Registry-based Randomized Clinical Trial|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||October 2022|
|Estimated Study Completion Date :||June 2030|
Experimental: FFR Treatment Arm
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
Fractional Flow Reserve-guided PCI of non-culprit lesions during index hospital admission
Active Comparator: Conservative Treatment Arm
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
Initial Conservative management of non-culprit lesions during index hospital admission
- Combined endpoint of all-cause mortality and myocardial infarction [ Time Frame: 1 year ]Combined endpoint of all-cause mortality and myocardial infarction during follow-up of minimum 1 year (all events when the last patient has been followed for 1 year).
- Number of patients with unplanned revascularization (PCI/CABG) of the coronary arteries [ Time Frame: 1 year ]Key Secondary Endpoint is unplanned revascularization (PCI/CABG) during follow-up of minimum 1 year (all events when the last patient has been followed for 1 year). All revascularizations will be adjudicated.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02862119
|Karolinska University Hospital|
|Stockholm, Sweden, S-171 76|
|Principal Investigator:||Felix Bohm, MD, PhD||Karolinska Institutet|
|Study Chair:||Stefan James, Professor||Uppsala University, Sweden|
|Study Director:||Andreas Rück, MD, PhD||Karolinska University Hospital|
|Study Director:||Eigil Fossum, MD, PhD||OUS Ullevål, Oslo, Norway|
|Study Director:||Thomas Engstrøm, MD, PhD||Rigshospitalet, Denmark|
|Study Director:||Thorarinn Gudnasson, MD, PhD||Landspitali, Reykjavik, Iceland|
|Study Director:||Mika Laine, MD, PhD||Helsinki University Hospital, Finland|
|Study Director:||Dariusz Dudek, Professor||Krakow, Poland|
|Study Director:||Andrejs Erglis, Professor||Riga, Latvia|