FAME II - Fractional Flow Reserve (FFR) Guided Percutaneous Coronary Intervention (PCI) Plus Optimal Medical Treatment (OMT) Verses OMT

NCT01132495 | Completed Results DMC

• 1 other identifier: 0904
• Study Type: interventional
• Target: 1,170
• Locations: 12 countries
• Sites: 28

Brief Summary

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.

Conditions

Coronary Artery Disease

Keywords

Stable angina; angina pectoris; PCI; FAME; FAME II; FFR; Fractional Flow Reserve; Pressure wire

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiac Event Rate (MACE)

  MACE: A composite of all cause death, documented MI, unplanned hospitalization leading to urgent revascularization.

  24 Month

Secondary Outcomes (1)

• Overall MACE

  3 years

Study Arms (3)

Cohort A: PCI plus OMT

OTHER

PCI plus optimal medical treatment

Other: Stenting plus OMT

Cohort A: OMT alone

OTHER

Optimal medical treatment alone

Other: OMT

Cohort B

OTHER

FFR \> 0.80; treatment according to local practice

Other: Standard of care

Interventions

Stenting plus OMT OTHER

FFR guided PCI, plus OMT

Cohort A: PCI plus OMT

OMT OTHER

OMT alone

Cohort A: OMT alone

Standard of care OTHER

FFR \> 0.80; treatment according to local practice

Cohort B

Eligibility Criteria

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

You may qualify if:

• Patients with
• stable angina or,
• stabilized angina pectoris or,
• atypical chest pain or no chest pain but with documented silent ischemia
• 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

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 STEMI or Non-STEMI
• Prior CABG
• Contra-indication to dual antiplatelet therapy
• LVEF \< 30%
• Severe LV hypertrophy
• Planned need for concomitant cardiac surgery
• Extremely tortuous or calcified coronary arteries precluding FFR measurements
• A life expectancy of less than 2 years
• Age under 21

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (29)

VA Palo Alto

Palo Alto, California, 94304, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Atlanta VA Medical Center

Decatur, Georgia, 30033, United States

Location

Tulane University

New Orleans, Louisiana, 70112, United States

Location

Northeast Cardiology Associates

Bangor, Maine, 04401, United States

Location

OLV Ziekenhuis

Aalst, 9300, Belgium

Location

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, H2W 1T8, Canada

Location

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, H4J 1C5, Canada

Location

Masaryk University and University Hospital Brno

Brno, 625 00, Czechia

Location

Na Homolce Hospital

Prague, 150 16, Czechia

Location

Rigshospitalet University Hospital

Copenhagen, DK-2100, Denmark

Location

Hospices Civils de Lyon

Bron, 69677, France

Location

Heart Center Leipzig

Leipzig, 04289, Germany

Location

Klinikum der Universitat Munchen

München, 80336, Germany

Location

Stadtisches Klinikum Munchen

München, 80337, Germany

Location

Gottsegen Hungarian Institute of Cardiology

Budapest, 1086, Hungary

Location

Azienda Ospedaliero Universitaria de Ferrara

Ferrara, 44100, Italy

Location

Catharina-Ziekenhuis

Eindhoven, Netherlands

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Isala Klinieken

Zwolle, 8011 JW, Netherlands

Location

Clinical Center Kragujevac

Kragujevac, 34000, Serbia

Location

Orebro University Hospital

Örebro, 701 85, Sweden

Location

Sodersjukhuset AB

Stockholm, 11883, Sweden

Location

Royal Victoria Hospital

Belfast, BT12 6BA, United Kingdom

Location

Edinburgh Heart Centre

Edinburgh, EH16 4SA, United Kingdom

Location

Golden Jubilee National Hospital

Glasgow, G81 4HX, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

Southampton University Hospitals NHS

Southampton, SO16 6YD, United Kingdom

Location

Related Publications (8)

• 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.

  PMID: 30354650 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.

  PMID: 29785878 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.

  PMID: 29162610 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.

  PMID: 29097450 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.

  PMID: 27884241 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.

  PMID: 25176289 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.

  PMID: 23946263 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.

  PMID: 22924638 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Angina, Stable; Angina Pectoris

Interventions

Stents; Standard of Care

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostheses and Implants; Equipment and Supplies; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Results Point of Contact

• Title: Sr. Director, Global Clinical Affairs
• Organization: St. Jude Medical

jmifek@sjm.com

651-756-5586

Study Officials

• Bernard De Bruyne, MD

  O.L.Vrouwzlekenhuis Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2010
• First Posted: May 28, 2010
• Study Start: May 1, 2010
• Primary Completion: January 1, 2014
• Study Completion: May 1, 2015
• Last Updated: September 16, 2019
• Results First Posted: December 9, 2016

Record last verified: 2019-08

Locations

SE (2); HU (1); BE (1); CZ (2); DE (3); DK (1); US (6); CA (2); NL (3); IT (1); GB (5); FR (1)