Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes (FREEDOM)

NCT00086450 | Unknown Phase 3 Results DMC

• 3 other identifiers: GCO 02-0163U01HL071988R01 HL71988
• Study Type: interventional
• Target: 1,900
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to compare 5-year mortality rates in diabetic individuals with multivessel coronary artery disease (CAD) who undergo either coronary artery bypass grafting (CABG) surgery or percutaneous coronary stenting.

Conditions

Cardiovascular Diseases; Coronary Disease; Diabetes Mellitus; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke

  median 3.8 years of follow-up

  Measured at Year 5

Secondary Outcomes (3)

• Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization

  Measured at Year 1

• All-cause Mortality

  Measured at Year 5

• Rates of Individual MACCE Endpoints

  Measured at Day 30

Study Arms (2)

Coronary Artery Bypass Graft

ACTIVE COMPARATOR

Coronary Artery Bypass Graft

Procedure: Coronary Artery Bypass Graft

Percutaneous Coronary Intervention

EXPERIMENTAL

Percutaneous Coronary Intervention

Device: Percutaneous Coronary Intervention

Interventions

Coronary Artery Bypass Graft PROCEDURE

For CABG, participants will receive general anesthesia and will have a breathing tube placed in their throat and they will be unconscious during the operation. An incision is made through the chest bone and muscle, which allows the surgeon access to the heart and diseased vessels. The surgeon will use one or more healthy vessels (either from an artery in the shoulder or a vein in the leg) and will bypass the diseased vessel with the healthy vessel(s). This bypass will provide needed blood supply to the heart.

Also known as: CABG

Coronary Artery Bypass Graft

Percutaneous Coronary Intervention DEVICE

For PCI, the participant will have two or more drug-eluting stents permanently implanted in their clogged arteries. Drug-eluting stents are coated with a drug that may prevent the disease in the vessel from coming back. The brand names of the stents used in this study are TAXUS and CYPHER. The participant will receive a local anesthetic. A small puncture will be made and a balloon-tipped catheter is introduced through the small puncture in the leg/arm and advanced through the artery to the diseased heart vessel. The balloon is then inflated to enlarge the opening in the vessel. After enlarging the vessel, the drug-eluting stent will be placed using a similar balloon catheter. This balloon will be inflated, expanding the stent and placing it in the diseased vessel. Once the stent is fully expanded, the balloon is deflated and removed, leaving the stent in place in the artery.

Also known as: PCI

Percutaneous Coronary Intervention

Eligibility Criteria

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

You may qualify if:

• Diabetes mellitus (Type 1 or Type 2), defined according to the American Diabetes Association as either:
• presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random of greater than 200 mg/dL (11mmol/L) or
• fasting plasma glucose elevation on more than one occasion of at least 126 mg/dL (7mmol/L)
• Currently undergoing pharmacological or non-pharmacological treatment for diabetes
• Angiographically confirmed multivessel CAD \[critical (greater than or equal to 70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)\] amenable to either PCI or CABG
• Angiographic characteristics amendable to both PCI/DES and CABG
• Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia

You may not qualify if:

• Severe congestive heart failure (class III or IV according to New York Heart Association \[NYHA\] or pulmonary edema)
• Prior CABG surgery
• Prior valve surgery
• Prior PCI with stent implantation within 6 months of study entry
• Stroke within 6 months of study entry; if stroke occurred more than 6 months prior to study entry, must have significant residual neurologic involvement, as reflected in a Rankin Score of greater than 1
• Prior history of significant bleeding (within 6 months of study entry) that may occur during CABG or PCI/DES related anticoagulation
• In-stent restenosis of a target vessel
• Two or more chronic total occlusions in major coronary territories
• Left main stenosis (at least 50% diameter stenosis)
• Acute ST-elevation MI (Q-wave) within 72 hours of study entry requiring revascularization
• Abnormal creatine kinase level (greater than twice the normal limit); or abnormal CK-MB level at study entry
• Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g., valve repair/replacement, aneurysmectomy, carotid endarterectomy, or carotid stent)
• Cannot undergo either CABG or PCI/DES because of a coexisting medical condition
• Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis
• Intolerance to aspirin or both clopidogrel and ticlopidine

Sponsors & Collaborators

• Valentin Fuster: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

Related Publications (10)

• Takahashi K, Serruys PW, Fuster V, Farkouh ME, Spertus JA, Cohen DJ, Park SJ, Park DW, Ahn JM, Onuma Y, Kent DM, Steyerberg EW, van Klaveren D; SYNTAX, BEST, and FREEDOM Trial investigators. External Validation of the FREEDOM Score for Individualized Decision Making Between CABG and PCI. J Am Coll Cardiol. 2022 Apr 19;79(15):1458-1473. doi: 10.1016/j.jacc.2022.01.049.

  PMID: 35422242 DERIVED

• Esper RB, Farkouh ME, Ribeiro EE, Hueb W, Domanski M, Hamza TH, Siami FS, Godoy LC, Mathew V, French J, Fuster V. SYNTAX Score in Patients With Diabetes Undergoing Coronary Revascularization in the FREEDOM Trial. J Am Coll Cardiol. 2018 Dec 11;72(23 Pt A):2826-2837. doi: 10.1016/j.jacc.2018.09.046.

  PMID: 30522646 DERIVED

• Farkouh ME, Domanski M, Dangas GD, Godoy LC, Mack MJ, Siami FS, Hamza TH, Shah B, Stefanini GG, Sidhu MS, Tanguay JF, Ramanathan K, Sharma SK, French J, Hueb W, Cohen DJ, Fuster V; FREEDOM Follow-On Study Investigators. Long-Term Survival Following Multivessel Revascularization in Patients With Diabetes: The FREEDOM Follow-On Study. J Am Coll Cardiol. 2019 Feb 19;73(6):629-638. doi: 10.1016/j.jacc.2018.11.001. Epub 2018 Nov 11.

  PMID: 30428398 DERIVED

• van Diepen S, Fuster V, Verma S, Hamza TH, Siami FS, Goodman SG, Farkouh ME. Dual Antiplatelet Therapy Versus Aspirin Monotherapy in Diabetics With Multivessel Disease Undergoing CABG: FREEDOM Insights. J Am Coll Cardiol. 2017 Jan 17;69(2):119-127. doi: 10.1016/j.jacc.2016.10.043.

  PMID: 28081820 DERIVED

• Dangas GD, Farkouh ME, Sleeper LA, Yang M, Schoos MM, Macaya C, Abizaid A, Buller CE, Devlin G, Rodriguez AE, Lansky AJ, Siami FS, Domanski M, Fuster V; FREEDOM Investigators. Long-term outcome of PCI versus CABG in insulin and non-insulin-treated diabetic patients: results from the FREEDOM trial. J Am Coll Cardiol. 2014 Sep 23;64(12):1189-97. doi: 10.1016/j.jacc.2014.06.1182.

  PMID: 25236509 DERIVED

• Abdallah MS, Wang K, Magnuson EA, Spertus JA, Farkouh ME, Fuster V, Cohen DJ; FREEDOM Trial Investigators. Quality of life after PCI vs CABG among patients with diabetes and multivessel coronary artery disease: a randomized clinical trial. JAMA. 2013 Oct 16;310(15):1581-90. doi: 10.1001/jama.2013.279208.

  PMID: 24129463 DERIVED

• Farkouh ME, Boden WE, Bittner V, Muratov V, Hartigan P, Ogdie M, Bertolet M, Mathewkutty S, Teo K, Maron DJ, Sethi SS, Domanski M, Frye RL, Fuster V. Risk factor control for coronary artery disease secondary prevention in large randomized trials. J Am Coll Cardiol. 2013 Apr 16;61(15):1607-15. doi: 10.1016/j.jacc.2013.01.044.

  PMID: 23500281 DERIVED

• Magnuson EA, Farkouh ME, Fuster V, Wang K, Vilain K, Li H, Appelwick J, Muratov V, Sleeper LA, Boineau R, Abdallah M, Cohen DJ; FREEDOM Trial Investigators. Cost-effectiveness of percutaneous coronary intervention with drug eluting stents versus bypass surgery for patients with diabetes mellitus and multivessel coronary artery disease: results from the FREEDOM trial. Circulation. 2013 Feb 19;127(7):820-31. doi: 10.1161/CIRCULATIONAHA.112.147488. Epub 2012 Dec 31.

  PMID: 23277307 DERIVED

• Farkouh ME, Domanski M, Sleeper LA, Siami FS, Dangas G, Mack M, Yang M, Cohen DJ, Rosenberg Y, Solomon SD, Desai AS, Gersh BJ, Magnuson EA, Lansky A, Boineau R, Weinberger J, Ramanathan K, Sousa JE, Rankin J, Bhargava B, Buse J, Hueb W, Smith CR, Muratov V, Bansilal S, King S 3rd, Bertrand M, Fuster V; FREEDOM Trial Investigators. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012 Dec 20;367(25):2375-84. doi: 10.1056/NEJMoa1211585. Epub 2012 Nov 4.

  PMID: 23121323 DERIVED

• Bansilal S, Farkouh ME, Hueb W, Ogdie M, Dangas G, Lansky AJ, Cohen DJ, Magnuson EA, Ramanathan K, Tanguay JF, Muratov V, Sleeper LA, Domanski M, Bertrand ME, Fuster V. The Future REvascularization Evaluation in patients with Diabetes mellitus: optimal management of Multivessel disease (FREEDOM) trial: clinical and angiographic profile at study entry. Am Heart J. 2012 Oct;164(4):591-9. doi: 10.1016/j.ahj.2012.06.012.

  PMID: 23067919 DERIVED

MeSH Terms

Conditions

Cardiovascular Diseases; Coronary Disease; Diabetes Mellitus; Heart Diseases

Interventions

Coronary Artery Bypass; Percutaneous Coronary Intervention

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Myocardial Revascularization; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Thoracic Surgical Procedures; Endovascular Procedures; Minimally Invasive Surgical Procedures

Limitations and Caveats

Since the trial was not blinded, patients may have been treated differently on the basis of their surgical procedure.

Results Point of Contact

• Title: Dr. Valentin Fuster, M.D., Ph.D.
• Organization: Icahn School of Medicine at Mount Sinai

valentin.fuster@mssm.edu

212-860-1056

Study Officials

• Valentin Fuster

  Icahn School of Medicine at Mount Sinai

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physician-in-Chief

Study Record Dates

• First Submitted: July 1, 2004
• First Posted: July 5, 2004
• Study Start: April 1, 2004
• Primary Completion: July 1, 2012
• Study Completion: December 1, 2018
• Last Updated: February 6, 2017
• Results First Posted: February 6, 2017

Record last verified: 2016-12

Locations

US (1)