FAME II-10-year Follow-Up

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT06159231
• Lead Sponsor: CoreAalst BV

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-03-30
• Study Start: 2023-04-25
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-06
• Primary Completion: 2024-05-15
• Study Completion: 2024-05-15
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 888

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The rate of major adverse cardiac events after 10 years of follow-up	10 years	10-year major adverse cardiac event rate (MACE, defined as all-cause death, documented myocardial infarction, unplanned hospitalization leading to urgent revascularization).

Secondary Outcome Measures

Name	Time	Method
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).	10 years	Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Comparison of the rate of documented myocardial infarction 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).
Comparison of the rate of unplanned hospitalization leading to urgent revascularization 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).

Trial Locations

Locations (16)

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Atlanta VA Medical Center; 🇺🇸 Decatur, Georgia, United States

Northern Light Eastern Maine Medical Center; 🇺🇸 Bangor, Maine, United States

Cardiovascular Center Aalst; 🇧🇪 Aalst, Belgium

Masaryk University - Dept. of Internal Cardiology Medicine; 🇨🇿 Brno, Moravia, Czechia

Nemocnice Na Homolce; 🇨🇿 Praha, Czechia

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Hopital Cardiovasculaire et Pneumologique Louis Pradel; 🇫🇷 Bron, Lyon, France

Universität Leipzig Herzzentrum; 🇩🇪 Leipzig, Saxony, Germany

München Klinikum Innenstadt; 🇩🇪 München, Germany

Gottsegen Hungarian Institute of Cardiology; 🇭🇺 Budapest, Hungary

Azienda Ospedaliera Universitaria S. Anna (Ferrara); 🇮🇹 Cona, Ferrara, Italy

Catharina Ziekenhuis; 🇳🇱 Eindhoven, Noord-Brabant, Netherlands

Clinical Hospital Center Kragujevac; 🇷🇸 Kragujevac, Šumadija, Serbia

Sodersjukhuset; 🇸🇪 Stockholm, Sweden

Universitestssjukhuset i Örebro; 🇸🇪 Örebro, Sweden