Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization Trial

NCT02477371 | Completed

• 1 other identifier: S-20130050
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Cardiovascular Diseases

Outcome Measures

Primary Outcomes (1)

• 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)

  6 months

Secondary Outcomes (6)

• Graft stenosis (shaft and anastomoses)

  6 months

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

  6 months

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

  6 months

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

  6 months

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

  The first 24 hours after the operation

Study Arms (2)

Fractional flow reserve-guided CABG

EXPERIMENTAL

Patients are randomized to an FFR-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan form the heart team meeting are changed by the study investigator according to the FFR-measurements and randomization, so that coronary arteries with FFR ≤ 0,8 receive grafting and coronary arteries with FFR \> 0,8 are deferred.

Procedure: Fractional flow reserve-guided CABG

Angiography-guided CABG

ACTIVE COMPARATOR

Patients are randomized to an angiography-guided CABG. FFR-measurements are made on coronary arteries with intermediate stenoses, that are planned for grafting. The FFR-values are blinded for both the operator, the patient and the heart team meeting. The graft plan are based on the coronary angiography.

Procedure: Angiography-guided CABG

Interventions

Fractional flow reserve-guided CABG PROCEDURE

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.

Fractional flow reserve-guided CABG

Angiography-guided CABG PROCEDURE

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.

Angiography-guided CABG

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (3)

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

Aarhus, Aarhus N, 8200, Denmark

Location

Anne Langhoff Thuesen

Odense, Odense C, 5000, Denmark

Location

Department of Cardiology and Cardiothoracic surgery, Aalborg University Hospital

Aalborg, 9100, Denmark

Location

Related Publications (2)

• Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Borregaard B, Junker A, Mortensen PE, Jensen LO. Health-Related Quality of Life and Angina in Fractional Flow Reserve- Versus Angiography-Guided Coronary Artery Bypass Grafting: FARGO Trial (Fractional Flow Reserve Versus Angiography Randomization for Graft Optimization). Circ Cardiovasc Qual Outcomes. 2021 Jun;14(6):e007302. doi: 10.1161/CIRCOUTCOMES.120.007302. Epub 2021 Jun 3.

  PMID: 34078097 DERIVED

• Thuesen AL, Riber LP, Veien KT, Christiansen EH, Jensen SE, Modrau I, Andreasen JJ, Junker A, Mortensen PE, Jensen LO. Fractional Flow Reserve Versus Angiographically-Guided Coronary Artery Bypass Grafting. J Am Coll Cardiol. 2018 Dec 4;72(22):2732-2743. doi: 10.1016/j.jacc.2018.09.043.

  PMID: 30497559 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Heart Diseases; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Anne Langhoff Thuesen, MD

  Department of Cardio-thoracic surgery, Odense University Hospital

  PRINCIPAL INVESTIGATOR

• Lisette Okkels Jensen, MD,PhD,DMSc

  Department of Cardiology, Odense University Hospital

  STUDY DIRECTOR

• Per Thayssen, MD, DMSc

  Department of Cardiology, Odense University Hospital

  STUDY CHAIR

• Poul Erik Mortensen, MD

  Department of Cardio-thoracic surgery, Odense University Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: January 19, 2015
• First Posted: June 22, 2015
• Study Start: June 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: October 18, 2018

Record last verified: 2018-10

Locations

DK (3)