FAME II-10-year Follow-Up

NCT06159231 | Completed

• 1 other identifier: CRI-086
• Study Type: observational
• Target: 888
• Locations: 10 countries
• Sites: 14

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• The rate of major adverse cardiac events after 10 years of follow-up

  10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).

  10 years

Secondary Outcomes (3)

• Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).

  10 years

• Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).

  10 years

• Comparison of the rate of unplanned hospitalization leading to urgent revascularization between randomization arms (of the original FAME2 study).

  10 years

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• Patients with
• stable angina pectoris (Canadian Cardiovascular Society Class \[CCS\] 1, 2, 3)
• or, angina pectoris CCS class 4 subsequently stabilized medically (minimum 7 days) or,
• atypical chest pain or no chest pain but with documented silent ischemia on non-invasive testing.
• 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
• Eligible for PCI
• Signed written informed consent was obtained. Patients will have to sign a specific informed consent for the present 10-year follow-up.

You may not qualify if:

• Patients in whom the preferred treatment is CABG
• Patients with left main coronary artery disease requiring revascularization
• Patients with a recent (less than 1 WEEK) STEMI or Non-STEMI
• Prior CABG
• Contra-indication to dual antiplatelet therapy
• LVEF \< 30%
• Severe LV hypertrophy (defined as a septal wall thickness at echocardiography of more than 13 mm)
• Planned need for concomitant cardiac surgery (e.g., valve surgery or resection of aortic or left ventricular aneurysm etc.)
• Extremely tortuous or calcified coronary arteries precluding FFR measurements
• A life expectancy of less than 2 years
• Age under 21
• Pregnancy or intention to become pregnant during the course of the trial
• 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
• Potential for non-compliance towards the requirements in the trial protocol (especially the medical treatment) or follow-up visits
• Participation or planned participation in another cardiovascular clinical trial before two year follow-up is completed

Sponsors & Collaborators

• CoreAalst BV: lead
• Abbott Medical Devices: collaborator

Study Sites (16)

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Northern Light Eastern Maine Medical Center

Bangor, Maine, 04401, United States

Location

Cardiovascular Center Aalst

Aalst, 9300, Belgium

Location

Masaryk University - Dept. of Internal Cardiology Medicine

Brno, Moravia, 601 77, Czechia

Location

Nemocnice Na Homolce

Prague, 150 00, Czechia

Location

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Hopital Cardiovasculaire et Pneumologique Louis Pradel

Bron, Lyon, 69500, France

Location

Universität Leipzig Herzzentrum

Leipzig, Saxony, 04289, Germany

Location

München Klinikum Innenstadt

München, 80336, Germany

Location

Gottsegen Hungarian Institute of Cardiology

Budapest, Budapest, 1096, Hungary

Location

Azienda Ospedaliera Universitaria S. Anna (Ferrara)

Cona, Ferrara, 44124, Italy

Location

Catharina Ziekenhuis

Eindhoven, North Brabant, 5623 EJ, Netherlands

Location

Clinical Hospital Center Kragujevac

Kragujevac, Šumadija, 34000, Serbia

Location

Sodersjukhuset

Stockholm, Stockholm County, 118 83, Sweden

Location

Universitestssjukhuset i Örebro

Örebro, Örebro County, 701 85, Sweden

Location

Related Publications (1)

• Collet C, Mahendiran T, Fearon WF, Mizukami T, Munhoz D, Pijls NHJ, Tonino PAL, Barbato E, Piroth Z, Sreckovic M, Thiele H, El Farissi M, Witt N, Rioufol G, Kala P, Engstrom T, Mavromatis K, Frobert O, Verlee P, Brunner S, Mates M, Jagic N, Campo G, Pardaens S, Ikeda K, Pereira TV, da Costa BR, Fournier S, De Bruyne B, Juni P. Fractional flow reserve-guided percutaneous coronary intervention versus medical therapy for stable coronary artery disease: long-term results of the FAME 2 trial. Nat Med. 2026 Jan 15. doi: 10.1038/s41591-025-04132-5. Online ahead of print.

  PMID: 41540107 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: December 6, 2023
• Study Start: April 25, 2023
• Primary Completion: May 15, 2024
• Study Completion: May 15, 2024
• Last Updated: January 7, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (2); HU (1); US (3); FR (1); SE (1); DK (1); BE (1); IT (1); NL (1); DE (2)