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

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ClinicalTrials.gov Identifier: NCT00086450
Recruitment Status : Unknown
Verified December 2016 by Valentin Fuster, Icahn School of Medicine at Mount Sinai.
Recruitment status was:  Active, not recruiting
First Posted : July 5, 2004
Results First Posted : February 6, 2017
Last Update Posted : February 6, 2017
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Valentin Fuster, Icahn School of Medicine at Mount Sinai

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Cardiovascular Diseases
Coronary Disease
Diabetes Mellitus
Heart Diseases
Interventions Procedure: Coronary Artery Bypass Graft
Device: Percutaneous Coronary Intervention
Enrollment 1900
Recruitment Details All trial-eligible patients must have multivessel disease suitable for either approach as determined by both an interventional cardiologist and a surgical investigator. The interventionalist and surgeon at each site will document their intentions of which vessels are targets for revascularization.
Pre-assignment Details  
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Hide Arm/Group Description Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Period Title: Overall Study
Started 953 947
Completed 953 947
Not Completed 0 0
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft Total
Hide Arm/Group Description Percutaneous Coronary Intervention Coronary Artery Bypass Graft Total of all reporting groups
Overall Number of Baseline Participants 953 947 1900
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 953 participants 947 participants 1900 participants
63.2  (8.9) 63.1  (9.2) 63.1  (9.1)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 953 participants 947 participants 1900 participants
Female
255
  26.8%
289
  30.5%
544
  28.6%
Male
698
  73.2%
658
  69.5%
1356
  71.4%
1.Primary Outcome
Title 5-year Composite Endpoint of All-cause Mortality, Non-fatal Myocardial Infarction, and Stroke
Hide Description median 3.8 years of follow-up
Time Frame Measured at Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Hide Arm/Group Description:
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Overall Number of Participants Analyzed 953 947
Measure Type: Number
Unit of Measure: percentage of participants
26.6 18.7
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Percutaneous Coronary Intervention, Coronary Artery Bypass Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.005
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Cox Proportional Hazard
Estimated Value 7.9
Confidence Interval 95%
3.3 to 12.5
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Major MACCE Rates, Including the First of One of the Following: Death, Myocardial Infarction, Stroke, or Repeat Revascularization
Hide Description [Not Specified]
Time Frame Measured at Year 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Hide Arm/Group Description:
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Overall Number of Participants Analyzed 953 947
Measure Type: Number
Unit of Measure: percentage of participants
16.8 11.8
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Percutaneous Coronary Intervention, Coronary Artery Bypass Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 2.74
Confidence Interval 95%
1.91 to 3.89
Estimation Comments [Not Specified]
3.Secondary Outcome
Title All-cause Mortality
Hide Description [Not Specified]
Time Frame Measured at Year 5
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Hide Arm/Group Description:
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Overall Number of Participants Analyzed 953 947
Measure Type: Number
Unit of Measure: percentage of participants
16.3 10.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Percutaneous Coronary Intervention, Coronary Artery Bypass Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.049
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 5.4
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Rates of Individual MACCE Endpoints
Hide Description Major adverse cardiovascular and cerebrovascular events
Time Frame Measured at Day 30
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Hide Arm/Group Description:
Percutaneous Coronary Intervention
Coronary Artery Bypass Graft
Overall Number of Participants Analyzed 953 947
Measure Type: Number
Unit of Measure: percentage of participants
4.8 5.2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Percutaneous Coronary Intervention, Coronary Artery Bypass Graft
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.68
Comments [Not Specified]
Method Regression, Cox
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Hide Arm/Group Description Percutaneous Coronary Intervention Coronary Artery Bypass Graft
All-Cause Mortality
Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   24/953 (2.52%)      42/947 (4.44%)    
Blood and lymphatic system disorders     
Major bleeding   23/953 (2.41%)  23 34/947 (3.59%)  34
Renal and urinary disorders     
Acute Renal Failure   1/953 (0.10%)  1 8/947 (0.84%)  8
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Percutaneous Coronary Intervention Coronary Artery Bypass Graft
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   44/953 (4.62%)      37/947 (3.91%)    
Renal and urinary disorders     
Renal insufficiency   44/953 (4.62%)  44 37/947 (3.91%)  37
Indicates events were collected by systematic assessment
Since the trial was not blinded, patients may have been treated differently on the basis of their surgical procedure.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Valentin Fuster, M.D., Ph.D.
Organization: Icahn School of Medicine at Mount Sinai
Phone: 212-860-1056
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Valentin Fuster, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT00086450     History of Changes
Other Study ID Numbers: GCO 02-0163
U01HL071988 ( U.S. NIH Grant/Contract )
R01 HL71988
First Submitted: July 1, 2004
First Posted: July 5, 2004
Results First Submitted: September 13, 2016
Results First Posted: February 6, 2017
Last Update Posted: February 6, 2017