Clinical trial NCT06159231: FAME II-10-year Follow-Up
Official title: Fractional Flow Reserve-guided Percutaneous Coronary Intervention Plus Optimal Medical Treatment Versus Optimal Medical Treatment Alone in Patients with Stable Coronary Artery Disease - FAME II, a 10-year Follow-up Study.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Lead sponsor: CoreAalst BV
Sponsor class: INDUSTRY
Collaborators: name: Abbott Medical Devices
First posted: 2023-12-06
Enrollment: 888
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that were enrolled in the original FAME2 study, i.e. consecutive patients with stable clinical condition and angiographically defined one-, two, or three-vessel coronary artery disease and amenable for PCI

Brief summary: The FAME-II trial was a prospective, multicenter, multinational, multi-continental, randomized clinical trial with an 'all comers' design.

The overall purpose of the FAME-II trial was to compare the clinical outcomes, safety and cost-effectiveness of FFR-guided PCI plus optimal medical treatment (OMT) versus OMT alone in patients with stable coronary artery disease and in whom both PCI and medical treatment can be considered on the basis of the presently existing scientific evidence.

FAME-II was conducted from 2009 to 2012 and 1-year, 2-year and 5-year results have been published.

The purpose of this 10-Year Follow-up is to evaluate the 10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).

Patients will have to sign a specific informed consent for the present 10-year follow-up.

This study will be conducted for about approximately 6 months.


Eligibility criteria: Inclusion Criteria:

1. Patients with

   1. stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3)
   2. or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
   3. atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
2. In whom at least one stenosis was present of at least 50% in one major native epicardial coronary artery with a diameter of at least 2.5 mm and supplying viable myocardium
3. Eligible for PCI
4. Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.

Exclusion Criteria:

1. Patients in whom the preferred treatment is CABG
2. Patients with left main coronary artery disease requiring revascularization
3. Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
4. Prior CABG
5. Contra-indication to dual antiplatelet therapy
6. LVEF \< 30%
7. Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
8. Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
9. Extremely tortuous or calcified coronary arteries precluding FFR measurements
10. A life expectancy of less than 2 years
11. Age under 21
12. Pregnancy or intention to become pregnant during the course of the trial
13. Refusal or inability to sign an informed consent. Mental condition (psychiatric or organ cerebral disease) rendering the subject unable to understand the nature, scope, and possible consequences of the trial or mental retardation or language barrier such that the patient is unable to give informed consent
14. Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
15. Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed

Primary outcomes:
measure: The rate of major adverse cardiac events after 10 years of follow-up
timeFrame: 10 years
Secondary outcomes:
measure: Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
timeFrame: 10 years
measure: Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
timeFrame: 10 years
measure: Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).
timeFrame: 10 years
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Decatur
country: United States
facility: Atlanta VA Medical Center
state: Georgia
city: Bangor
country: United States
facility: Northern Light Eastern Maine Medical Center
state: Maine
city: Aalst
country: Belgium
facility: Cardiovascular Center Aalst
city: Brno
country: Czechia
facility: Masaryk University - Dept. of Internal Cardiology Medicine
state: Moravia
city: Praha
country: Czechia
facility: Nemocnice Na Homolce
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Bron
country: France
facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel
state: Lyon
city: Leipzig
country: Germany
facility: Universität Leipzig Herzzentrum
state: Saxony
city: München
country: Germany
facility: München Klinikum Innenstadt
city: Budapest
country: Hungary
facility: Gottsegen Hungarian Institute of Cardiology
city: Cona
country: Italy
facility: Azienda Ospedaliera Universitaria S. Anna (Ferrara)
state: Ferrara
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
state: Noord-Brabant
city: Kragujevac
country: Serbia
facility: Clinical Hospital Center Kragujevac
state: Šumadija
city: Stockholm
country: Sweden
facility: Sodersjukhuset
city: Örebro
country: Sweden
facility: Universitestssjukhuset i Örebro
Study officials:
References: