Clinical trial NCT01881555: Functional Testing Underlying Coronary Revascularisation
Official title: FUnctional Testing Underlying Coronary REvascularisation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multivessel Coronary Artery Disease
Vessel Disease
Stable Angina
Unstable Angina or Stabilized Non-ST Elevated Myocardial Infarction
Patients With ST-elevated Myocardial Infarction
Revascularization of Culprit Coronary Artery
Keywords: fractional flow reserve
multivessel coronary artery disease
angiography
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2013-06-19
Enrollment: 941
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this trial is to compare the clinical outcomes and cost-effectiveness of 2 therapeutic strategies, one based on coronary angiography guidance and the other based on coronary angiography with fractional flow reserve (FFR) in multivessel coronary artery disease patients.

The trial is a prospective, multicenter, French, randomized clinical trial including men and women ≥ 18 years presenting with significant multivessel disease defined by coronary angiography as coronary narrowing \> 50% diameter stenosis in at least 2 major epicardic vessels. The patients who give their informed consent will be randomly assigned to a therapeutic strategy based upon coronary angiography or angiography with FFR testing. In the FFR group, a significant coronary stenosis will be defined by a FFR ≤ 0.8. Based upon this multivessel evaluation (angiography or FFR), the investigator will choose the best therapeutic strategy to his discretion (medical optimal treatment, coronary stenting, coronary artery bypass graft surgery). The aim of revascularization procedures will be to obtain complete revascularization. In the FFR group, only stenosis with FFR≤0.8 will be treated.

The primary end point of the trial is a composite of major cardiovascular events including death from any cause, myocardial infarction, any hospitalization for coronary revascularization performed in addition to initial treatment and stroke at 1 year of follow-up.

Secondary end points will include adverse events, individual major cardiovascular events, stent thrombosis, bleeding events, occlusion of coronary artery bypass graft, patient's quality of life and cost-effectiveness and 30-day, 6 month, 2-year and 5-year outcomes.


Eligibility criteria: Inclusion Criteria:

* age \> 18
* referred to the cardiologist for one of the following medical condition :

  * ST segment elevation myocardial infarction evolving for more than 7 days after revascularization of culprit coronary artery or
  * no ST elevation acute coronary syndrome with or without troponin (T or I) elevation and medically stabilized for at least 12 hours or
  * stable angina (CCS I, II or III) or
  * chest pain diagnosis with suspicion of CAD or with ischemia certificated by non invasive tests.
  * patients with at least 2 vessel disease (≥50% stenosis on angiography) including the left anterior descending coronary artery or with single vessel disease on left main coronary artery
* Patient willing and able to provide informed, written consent
* Patient not under legal protection
* Patient benefiting from the French Health Insurance

Exclusion Criteria:

* Pregnancy, childbearing, absence of effective contraception
* Previous coronary bypass surgery
* Planned associated valvular surgery
* Life expectancy \< 2 years

Primary outcomes:
measure: composite endpoint that includes the rate of major cardiovascular events defined as a composite of death from any cause, myocardial infarction, any hospitalization leading to additional coronary revascularization, stroke.
timeFrame: 1 year.
measure: Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
timeFrame: 1 year
Secondary outcomes:
measure: Major cardiovascular events in all patients, in diabetic patients, by revascularization strategy (angioplasty, coronary artery bypass graft surgery, medical optimal treatment).
timeFrame: 1 year
measure: The effect of our therapeutic strategy will be assessed upon each category of cardiovascular event individually.
timeFrame: 1 year
measure: Major cardiovascular events in all patients.
timeFrame: 2 years, 3 years, 4 years and 5 years
measure: Stent thrombosis.
timeFrame: 1 year
measure: Bleeding events.
timeFrame: 1 year
measure: Patient's quality of life
timeFrame: 1 year
measure: Cost-effectiveness of each therapeutic strategy
timeFrame: 1 year
measure: Bypass graft patency assessed in all CABG patients at one year by coronary multidetector computed tomography .
timeFrame: 1 year
Other outcomes:
Locations:
city: Lyon
country: France
facility: HOSPICES
Study officials:
References:
citation: Rioufol G, Derimay F, Roubille F, Perret T, Motreff P, Angoulvant D, Cottin Y, Meunier L, Cetran L, Cayla G, Harbaoui B, Wiedemann JY, Van Belle E, Pouillot C, Noirclerc N, Morelle JF, Soto FX, Caussin C, Bertrand B, Lefevre T, Dupouy P, Lesault PF, Albert F, Barthelemy O, Koning R, Leborgne L, Barnay P, Chapon P, Armero S, Lafont A, Piot C, Amaz C, Vaz B, Benyahya L, Varillon Y, Ovize M, Mewton N, Finet G; FUTURE Trial Investigators. Fractional Flow Reserve to Guide Treatment of Patients With Multivessel Coronary Artery Disease. J Am Coll Cardiol. 2021 Nov 9;78(19):1875-1885. doi: 10.1016/j.jacc.2021.08.061.