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.
Study Type
OBSERVATIONAL
Enrollment
888
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
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Bron, Lyon, France
Universität Leipzig Herzzentrum
Leipzig, Saxony, Germany
München Klinikum Innenstadt
München, Germany
...and 6 more locations
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).
Time frame: 10 years
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Comparison of the rate of all-cause death between randomization arms (of the original FAME2 study).
Time frame: 10 years
Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
Comparison of the rate of documented myocardial infarction between randomization arms (of the original FAME2 study).
Time frame: 10 years
Comparison of the rate of unplanned hospitalization leading to urgent revascularization 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).
Time frame: 10 years
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