Arteriosclerosis, Cardiovascular Diseases, Coronary Artery Disease, Coronary Disease, Myocardial Ischemia
Conditions
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.
Detailed description
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.
Interventions
PROCEDUREFractional flow reserve-guided CABG
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.
PROCEDUREAngiography-guided CABG
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.
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage open grafts of all grafts | 6 months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure time | During surgery (minutes) | — |
| Graft stenosis (shaft and anastomoses) | 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 | — |
| 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 | — |
| Change in CCS class from index to follow-up (FU) | 6 months | CCS class (Canadian Cardiovascular Society grading of angina) |
Countries
Denmark
Outcome results
None listed