Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

Odense University Hospital100 enrolled

Overview

The FARGO trial is a prospective, randomized (1:1), multicenter study. The aim of the study is to assess the importance of fractional flow reserve (FFR) assessment prior to coronary artery bypass grafting (CABG) with respect to planning and guiding the revascularization strategy. The study compares an FFR-guided strategy to an angiography-guided strategy in patients planned for surgical revascularization.

FFR measurements are made on all patients that enters the study. FFR measurements on coronary arteries with intermediate stenoses, that are planned for grafting, are done before CABG is performed. Patients are randomized to either an FFR-guided CABG or an Angiography guided CABG.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

100

Conditions

Coronary Artery Disease Coronary Disease Myocardial Ischemia Arteriosclerosis

Interventions

Fractional flow reserve-guided CABGPROCEDURE

Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting and where FFR-measurements are made, only receive grafting if FFR-value is ≤ 0,8. Arteries with FFR-values \> 0,8 are deferred.

Angiography-guided CABGPROCEDURE

Coronary arteries with angiographical significant stenoses, that are planned for grafting at the heart team meeting all receive grafting. FFR-measurements are still made, but not used for guidance of grafting.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Stable angina or unstable angina / NSTEMI (Non ST segment elevation myocardial infarction) candidate to CABG * At least one study lesion, which is an intermediate lesion planned for grafting at the Heart Team Meeting.(Definition of Study lesions: ≥ 50% stenosis of a major epicardiel artery (where the proximal reference segment has a diameter\> 2.5 mm), which can be passed with a FFR-wire without significant risk. Study Lesions can be drawn from all coronary arteries.) * Signed informed consent form Exclusion Criteria: * Significant valvular disease with indication to surgical treatment * Previous open-heart-surgery * Left main lesion without other intermediate lesions * Treatment with Persantin Retard * One vessel disease * Renal impairment (creatinine ≥ 150 umol / l)

Locations (3)

Department of Cardiology and Cardiothoracic surgery, Aarhus University Hospital, Skejby Sygehus

Aarhus, Aarhus N, Denmark

Anne Langhoff Thuesen

Odense, Odense C, Denmark

Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital

Aalborg, Denmark

Outcomes

Primary Outcomes

Percentage open grafts of all grafts

Open graft definition: graft with TIMI III flow with no anastomosis stenosis (TIMI flow grades based on results of the Thrombolysis In Myocardial Infarction trial)

Time frame: 6 months

Secondary Outcomes

Graft stenosis (shaft and anastomoses)

Time frame: 6 months

Change in CCS class from index to follow-up (FU)

CCS class (Canadian Cardiovascular Society grading of angina)

Time frame: 6 months

Change in Quality of life (EQ-5D) from index to FU

Time frame: 6 months

MACCE (Major Adverse Cardiac and Cerebrovascular event: death, myocardial infarction, stroke, new revascularization by CABG or PCI (Percutaneous coronary intervention)

Time frame: 6 months

Procedural maximum Troponin I (cTnI), Troponin T (TnT) or creatinine kinase MB (CKMB) values depending on local conditions.

Time frame: The first 24 hours after the operation

Procedure time

Time frame: During surgery (minutes)