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The overall purpose of the FAME II trial is 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.
Prospective, multi-center, multi-national, multi-continental, randomized clinical trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort A: PCI plus OMT | Other | PCI plus optimal medical treatment |
|
| Cohort A: OMT alone | Other | Optimal medical treatment alone |
|
| Cohort B | Other | FFR > 0.80; treatment according to local practice |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stenting plus OMT | Other | FFR guided PCI, plus OMT |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Major Adverse Cardiac Event Rate (MACE) | MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization. | 24 Month |
| Measure | Description | Time Frame |
|---|---|---|
| Overall MACE | Individual components of the primary end point, cardiac death, and nonurgent revascularization | 3 years |
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Inclusion Criteria:
Patients with
at least one stenosis is present of at least 50% in one major native epicardial coronary artery and supplying viable myocardium
Eligible for PCI
Signed written informed consent
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bernard De Bruyne, MD | O.L.Vrouwzlekenhuis Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto | Palo Alto | California | 94304 | United States | ||
| Stanford University Medical Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30354650 | Derived | Nishi T, Piroth Z, De Bruyne B, Jagic N, Mobius-Winkler S, Kobayashi Y, Derimay F, Fournier S, Barbato E, Tonino P, Juni P, Pijls NHJ, Fearon WF. Fractional Flow Reserve and Quality-of-Life Improvement After Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease. Circulation. 2018 Oct 23;138(17):1797-1804. doi: 10.1161/CIRCULATIONAHA.118.035263. | |
| 29785878 |
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Participants were randomized to Cohort A if at least one stenoses had an FFR value of <=0.80. Participants with FFR >0.80 were treated according to local practice and were randomized to study follow-up / no study follow-up in Cohort B. Therefore, participants are either in cohort A or cohort B (not both).
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| ID | Title | Description |
|---|---|---|
| FG000 | Cohort A - PCI Plus OMT | PCI plus optimal medical treatment Stenting plus OMT: FFR guided PCI, plus OMT |
| FG001 | Cohort A - OMT Alone | Optimal medical treatment alone Standard of care: OMT alone |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| OMT |
| Other |
OMT alone |
|
| Standard of care | Other | FFR > 0.80; treatment according to local practice |
|
| Stanford |
| California |
| 94305 |
| United States |
| Emory University | Atlanta | Georgia | 30322 | United States |
| Atlanta VA Medical Center | Decatur | Georgia | 30033 | United States |
| Tulane University | New Orleans | Louisiana | 70112 | United States |
| Northeast Cardiology Associates | Bangor | Maine | 04401 | United States |
| OLV Ziekenhuis | Aalst | 9300 | Belgium |
| Centre Hospitalier de l'Universite de Montreal | Montreal | Quebec | H2W 1T8 | Canada |
| Hopital du Sacre-Coeur de Montreal | Montreal | Quebec | H4J 1C5 | Canada |
| Masaryk University and University Hospital Brno | Brno | 625 00 | Czechia |
| Na Homolce Hospital | Prague | 150 16 | Czechia |
| Rigshospitalet University Hospital | Copenhagen | DK-2100 | Denmark |
| Hospices Civils de Lyon | Bron | 69677 | France |
| Heart Center Leipzig | Leipzig | 04289 | Germany |
| Klinikum der Universitat Munchen | München | 80336 | Germany |
| Stadtisches Klinikum Munchen | München | 80337 | Germany |
| Gottsegen Hungarian Institute of Cardiology | Budapest | 1086 | Hungary |
| Azienda Ospedaliero Universitaria de Ferrara | Ferrara | 44100 | Italy |
| Catharina-Ziekenhuis | Eindhoven | Netherlands |
| St. Antonius Ziekenhuis | Nieuwegein | 3435 CM | Netherlands |
| Isala Klinieken | Zwolle | 8011 JW | Netherlands |
| Clinical Center Kragujevac | Kragujevac | 34000 | Serbia |
| Orebro University Hospital | Örebro | 701 85 | Sweden |
| Sodersjukhuset AB | Stockholm | 11883 | Sweden |
| Royal Victoria Hospital | Belfast | BT12 6BA | United Kingdom |
| Edinburgh Heart Centre | Edinburgh | EH16 4SA | United Kingdom |
| Golden Jubilee National Hospital | Glasgow | G81 4HX | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| Southampton University Hospitals NHS | Southampton | SO16 6YD | United Kingdom |
| Derived |
| Xaplanteris P, Fournier S, Pijls NHJ, Fearon WF, Barbato E, Tonino PAL, Engstrom T, Kaab S, Dambrink JH, Rioufol G, Toth GG, Piroth Z, Witt N, Frobert O, Kala P, Linke A, Jagic N, Mates M, Mavromatis K, Samady H, Irimpen A, Oldroyd K, Campo G, Rothenbuhler M, Juni P, De Bruyne B; FAME 2 Investigators. Five-Year Outcomes with PCI Guided by Fractional Flow Reserve. N Engl J Med. 2018 Jul 19;379(3):250-259. doi: 10.1056/NEJMoa1803538. Epub 2018 May 22. |
| 29162610 | Derived | Ciccarelli G, Barbato E, Toth GG, Gahl B, Xaplanteris P, Fournier S, Milkas A, Bartunek J, Vanderheyden M, Pijls N, Tonino P, Fearon WF, Juni P, De Bruyne B. Angiography Versus Hemodynamics to Predict the Natural History of Coronary Stenoses: Fractional Flow Reserve Versus Angiography in Multivessel Evaluation 2 Substudy. Circulation. 2018 Apr 3;137(14):1475-1485. doi: 10.1161/CIRCULATIONAHA.117.028782. Epub 2017 Nov 21. |
| 29097450 | Derived | Fearon WF, Nishi T, De Bruyne B, Boothroyd DB, Barbato E, Tonino P, Juni P, Pijls NHJ, Hlatky MA; FAME 2 Trial Investigators. Clinical Outcomes and Cost-Effectiveness of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention in Patients With Stable Coronary Artery Disease: Three-Year Follow-Up of the FAME 2 Trial (Fractional Flow Reserve Versus Angiography for Multivessel Evaluation). Circulation. 2018 Jan 30;137(5):480-487. doi: 10.1161/CIRCULATIONAHA.117.031907. Epub 2017 Nov 2. |
| 27884241 | Derived | Barbato E, Toth GG, Johnson NP, Pijls NH, Fearon WF, Tonino PA, Curzen N, Piroth Z, Rioufol G, Juni P, De Bruyne B. A Prospective Natural History Study of Coronary Atherosclerosis Using Fractional Flow Reserve. J Am Coll Cardiol. 2016 Nov 29;68(21):2247-2255. doi: 10.1016/j.jacc.2016.08.055. |
| 25176289 | Derived | De Bruyne B, Fearon WF, Pijls NH, Barbato E, Tonino P, Piroth Z, Jagic N, Mobius-Winckler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd K, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Limacher A, Nuesch E, Juni P; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI for stable coronary artery disease. N Engl J Med. 2014 Sep 25;371(13):1208-17. doi: 10.1056/NEJMoa1408758. Epub 2014 Sep 1. |
| 23946263 | Derived | Fearon WF, Shilane D, Pijls NH, Boothroyd DB, Tonino PA, Barbato E, Juni P, De Bruyne B, Hlatky MA; Fractional Flow Reserve Versus Angiography for Multivessel Evaluation 2 (FAME 2) Investigators. Cost-effectiveness of percutaneous coronary intervention in patients with stable coronary artery disease and abnormal fractional flow reserve. Circulation. 2013 Sep 17;128(12):1335-40. doi: 10.1161/CIRCULATIONAHA.113.003059. Epub 2013 Aug 14. |
| 22924638 | Derived | De Bruyne B, Pijls NH, Kalesan B, Barbato E, Tonino PA, Piroth Z, Jagic N, Mobius-Winkler S, Rioufol G, Witt N, Kala P, MacCarthy P, Engstrom T, Oldroyd KG, Mavromatis K, Manoharan G, Verlee P, Frobert O, Curzen N, Johnson JB, Juni P, Fearon WF; FAME 2 Trial Investigators. Fractional flow reserve-guided PCI versus medical therapy in stable coronary disease. N Engl J Med. 2012 Sep 13;367(11):991-1001. doi: 10.1056/NEJMoa1205361. Epub 2012 Aug 27. |
| FG002 | Cohort B - Follow-up | Observation with treatment based on physician preference |
| FG003 | Cohort B - No Follow-up Re-consented | Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Cohort A - PCI Plus OMT | PCI plus optimal medical treatment Stenting plus OMT: FFR guided PCI, plus OMT |
| BG001 | Cohort A - OMT Alone | Optimal medical treatment alone Standard of care: OMT alone |
| BG002 | Cohort B - Follow-up | Observation with treatment based on physician preference |
| BG003 | Cohort B - No Follow-up Re-consented | Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Major Adverse Cardiac Event Rate (MACE) | MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization. | The primary outcome analysis was designed for Cohort A only. | Posted | Number | percentage of subjects with SAEs | 24 Month |
|
|
| ||||||||||||||||||||||||||||||||||||
| Secondary | Overall MACE | Individual components of the primary end point, cardiac death, and nonurgent revascularization | For registry cohort B, 50% of the patients with an FFR >0.80 across all lesions were followed up in a registry, and therefore, cohort B group for 'No Follow-up Re-consented' arm had no follow-up result and was not included in the endpoint analysis. | Posted | Number | percentage of subjects | 3 years |
|
|
Unanticipated adverse device effects (UADE), major adverse cardiac event (MACE), serious adverse event (SAE) and stent thrombosis will be monitored through subject withdrawal following 3 year study follow-up.
Only Serious Adverse Events were collected in this study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cohort A - PCI Plus OMT | PCI plus optimal medical treatment Stenting plus OMT: FFR guided PCI, plus OMT | 137 | 447 | 0 | 0 | ||
| EG001 | Cohort A - OMT Alone | Optimal medical treatment alone Standard of care: OMT alone | 324 | 441 | 0 | 0 | ||
| EG002 | Cohort B - Follow-up | Observation with treatment based on physician preference | 55 | 166 | 0 | 0 | ||
| EG003 | Cohort B - No Follow-up Re-consented | Observation with treatment based on physician preference, initially randomized to no follow-up, re-consented per safety data | 28 | 116 | 0 | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non Urgent Revacularization | Vascular disorders | Non-systematic Assessment |
| ||
| Death or MI | Cardiac disorders | Non-systematic Assessment |
| ||
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
| ||
| Unplanned Hospitalization with Urgent Revascularization | Vascular disorders | Non-systematic Assessment |
| ||
| Death | General disorders | Non-systematic Assessment |
| ||
| Cerebrovascular Event | General disorders | Non-systematic Assessment |
| ||
| Other SAE | General disorders | Non-systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sr. Director, Global Clinical Affairs | St. Jude Medical | 651-756-5586 | jmifek@sjm.com |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D060050 | Angina, Stable |
| D000787 | Angina Pectoris |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015607 | Stents |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019736 | Prostheses and Implants |
| D004864 | Equipment and Supplies |
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Male |
|
| Myocardial Infarction |
|
| Unplanned Hospitalizations with urgent revasc |
|
| Death |
|
| Cerebrovascular Event |
|
| Other Serious Adverse Event (SAE) |
|
| Participants |
|
|