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The Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry

Background The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous... Full description

Journal Title: The American heart journal 2012, Vol.164 (4), p.591-599
Main Author: Bansilal, Sameer, MD, MS
Other Authors: Farkouh, Michael E., MD, MSc , Hueb, Whady, MD , Ogdie, May , Dangas, George, MD, PhD , Lansky, Alexandra J., MD , Cohen, David J., MD, MSc , Magnuson, Elizabeth A., ScD , Ramanathan, Krishnan, MB, ChB , Tanguay, Jean-Francois, MD , Muratov, Victoria , Sleeper, Lynn A., ScD , Domanski, Michael, MD , Bertrand, Michel E., MD , Fuster, Valentin, MD, PhD
Format: Electronic Article Electronic Article
Language: English
Subjects:
Abridged Index Medicus
Australasia
Biological and medical sciences
Cardiology. Vascular system
Cardiovascular
Cardiovascular system
Care and treatment
Clinical trials
Coronary Artery Bypass
Coronary Artery Disease - pathology
Coronary Artery Disease - surgery
Coronary vessels
Diabetes
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - drug therapy
Diabetes Mellitus, Type 2 - epidemiology
Diabetes therapy
Diabetes. Impaired glucose tolerance
Diabetic Angiopathies - pathology
Diabetic Angiopathies - surgery
Diabetics
Drug therapy
Drug-Eluting Stents
Endocrine pancreas. Apud cells (diseases)
Endocrinopathies
Etiopathogenesis. Screening. Investigations. Target tissue resistance
Europe
Female
Heart attacks
Humans
Investigative techniques, diagnostic techniques (general aspects)
Male
Medical research
Medical sciences
Medicine, Experimental
Middle Aged
Mortality
Myocardial Infarction - prevention & control
North America
Radiodiagnosis. Nmr imagery. Nmr spectrometry
South America
Stroke - prevention & control
Quelle: Alma/SFX Local Collection
Publisher: New York, NY: Elsevier Inc
ID: ISSN: 0002-8703
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title: The Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry
format: Article
creator:
  • Bansilal, Sameer, MD, MS
  • Farkouh, Michael E., MD, MSc
  • Hueb, Whady, MD
  • Ogdie, May
  • Dangas, George, MD, PhD
  • Lansky, Alexandra J., MD
  • Cohen, David J., MD, MSc
  • Magnuson, Elizabeth A., ScD
  • Ramanathan, Krishnan, MB, ChB
  • Tanguay, Jean-Francois, MD
  • Muratov, Victoria
  • Sleeper, Lynn A., ScD
  • Domanski, Michael, MD
  • Bertrand, Michel E., MD
  • Fuster, Valentin, MD, PhD
subjects:
  • Abridged Index Medicus
  • Australasia
  • Biological and medical sciences
  • Cardiology. Vascular system
  • Cardiovascular
  • Cardiovascular system
  • Care and treatment
  • Clinical trials
  • Coronary Artery Bypass
  • Coronary Artery Disease - pathology
  • Coronary Artery Disease - surgery
  • Coronary vessels
  • Diabetes
  • Diabetes Mellitus, Type 2 - complications
  • Diabetes Mellitus, Type 2 - drug therapy
  • Diabetes Mellitus, Type 2 - epidemiology
  • Diabetes therapy
  • Diabetes. Impaired glucose tolerance
  • Diabetic Angiopathies - pathology
  • Diabetic Angiopathies - surgery
  • Diabetics
  • Drug therapy
  • Drug-Eluting Stents
  • Endocrine pancreas. Apud cells (diseases)
  • Endocrinopathies
  • Etiopathogenesis. Screening. Investigations. Target tissue resistance
  • Europe
  • Female
  • Heart attacks
  • Humans
  • Investigative techniques, diagnostic techniques (general aspects)
  • Male
  • Medical research
  • Medical sciences
  • Medicine, Experimental
  • Middle Aged
  • Mortality
  • Myocardial Infarction - prevention & control
  • North America
  • Radiodiagnosis. Nmr imagery. Nmr spectrometry
  • South America
  • Stroke - prevention & control
ispartof: The American heart journal, 2012, Vol.164 (4), p.591-599
description: Background The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. Methods A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. Results The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-8703
fulltext: fulltext
issn:
  • 0002-8703
  • 1097-6744
url: Link


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titleThe Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry
sourceAlma/SFX Local Collection
creatorBansilal, Sameer, MD, MS ; Farkouh, Michael E., MD, MSc ; Hueb, Whady, MD ; Ogdie, May ; Dangas, George, MD, PhD ; Lansky, Alexandra J., MD ; Cohen, David J., MD, MSc ; Magnuson, Elizabeth A., ScD ; Ramanathan, Krishnan, MB, ChB ; Tanguay, Jean-Francois, MD ; Muratov, Victoria ; Sleeper, Lynn A., ScD ; Domanski, Michael, MD ; Bertrand, Michel E., MD ; Fuster, Valentin, MD, PhD
creatorcontribBansilal, Sameer, MD, MS ; Farkouh, Michael E., MD, MSc ; Hueb, Whady, MD ; Ogdie, May ; Dangas, George, MD, PhD ; Lansky, Alexandra J., MD ; Cohen, David J., MD, MSc ; Magnuson, Elizabeth A., ScD ; Ramanathan, Krishnan, MB, ChB ; Tanguay, Jean-Francois, MD ; Muratov, Victoria ; Sleeper, Lynn A., ScD ; Domanski, Michael, MD ; Bertrand, Michel E., MD ; Fuster, Valentin, MD, PhD
descriptionBackground The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. Methods A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. Results The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 ± 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts. Conclusions The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD.
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languageeng
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subjectAbridged Index Medicus ; Australasia ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiovascular ; Cardiovascular system ; Care and treatment ; Clinical trials ; Coronary Artery Bypass ; Coronary Artery Disease - pathology ; Coronary Artery Disease - surgery ; Coronary vessels ; Diabetes ; Diabetes Mellitus, Type 2 - complications ; Diabetes Mellitus, Type 2 - drug therapy ; Diabetes Mellitus, Type 2 - epidemiology ; Diabetes therapy ; Diabetes. Impaired glucose tolerance ; Diabetic Angiopathies - pathology ; Diabetic Angiopathies - surgery ; Diabetics ; Drug therapy ; Drug-Eluting Stents ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Europe ; Female ; Heart attacks ; Humans ; Investigative techniques, diagnostic techniques (general aspects) ; Male ; Medical research ; Medical sciences ; Medicine, Experimental ; Middle Aged ; Mortality ; Myocardial Infarction - prevention & control ; North America ; Radiodiagnosis. Nmr imagery. Nmr spectrometry ; South America ; Stroke - prevention & control
ispartofThe American heart journal, 2012, Vol.164 (4), p.591-599
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10Muratov, Victoria
11Sleeper, Lynn A., ScD
12Domanski, Michael, MD
13Bertrand, Michel E., MD
14Fuster, Valentin, MD, PhD
title
0The Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry
1The American heart journal
addtitleAm Heart J
descriptionBackground The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. Methods A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. Results The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 ± 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts. Conclusions The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD.
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titleThe Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry
authorBansilal, Sameer, MD, MS ; Farkouh, Michael E., MD, MSc ; Hueb, Whady, MD ; Ogdie, May ; Dangas, George, MD, PhD ; Lansky, Alexandra J., MD ; Cohen, David J., MD, MSc ; Magnuson, Elizabeth A., ScD ; Ramanathan, Krishnan, MB, ChB ; Tanguay, Jean-Francois, MD ; Muratov, Victoria ; Sleeper, Lynn A., ScD ; Domanski, Michael, MD ; Bertrand, Michel E., MD ; Fuster, Valentin, MD, PhD
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1Australasia
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7Clinical trials
8Coronary Artery Bypass
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34Medicine, Experimental
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37Myocardial Infarction - prevention & control
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39Radiodiagnosis. Nmr imagery. Nmr spectrometry
40South America
41Stroke - prevention & control
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6Cohen, David J., MD, MSc
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atitleThe Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) trial: Clinical and angiographic profile at study entry
jtitleThe American heart journal
addtitleAm Heart J
date2012
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volume164
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pages591-599
issn0002-8703
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abstractBackground The optimal revascularization strategy for diabetic patients with multivessel coronary artery disease (MVD) remains uncertain for lack of an adequately powered, randomized trial. The FREEDOM trial was designed to compare contemporary coronary artery bypass grafting (CABG) to percutaneous coronary intervention (PCI) with drug-eluting stents in diabetic patients with MVD against a background of optimal medical therapy. Methods A total of 1,900 diabetic participants with MVD were randomized to PCI or CABG worldwide from April 2005 to March 2010. FREEDOM is a superiority trial with a mean follow-up of 4.37 years (minimum 2 years) and 80% power to detect a 27.0% relative reduction. We present the baseline characteristics of patients screened and randomized, and provide a comparison with other MVD trials involving diabetic patients. Results The randomized cohort was 63.1 ± 9.1 years old and 29% female, with a median diabetes duration of 10.2 ± 8.9 years. Most (83%) had 3-vessel disease and on average took 5.5 ± 1.7 vascular medications, with 32% on insulin therapy. Nearly all had hypertension and/or dyslipidemia, and 26% had a prior myocardial infarction. Mean hemoglobin A1c was 7.8 ± 1.7 mg/dL, 29% had low-density lipoprotein <70 mg/dL, and mean systolic blood pressure was 134 ± 20 mm Hg. The mean SYNTAX score was 26.2 with a symmetric distribution. FREEDOM trial participants have baseline characteristics similar to those of contemporary multivessel and diabetes trial cohorts. Conclusions The FREEDOM trial has successfully recruited a high-risk diabetic MVD cohort. Follow-up efforts include aggressive monitoring to optimize background risk factor control. FREEDOM will contribute significantly to the PCI versus CABG debate in diabetic patients with MVD.
copNew York, NY
pubElsevier Inc
pmid23067919
doi10.1016/j.ahj.2012.06.012
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