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Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial

Background Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. Th... Full description

Journal Title: The American heart journal 2008, Vol.155 (2), p.215-223
Main Author: Farkouh, Michael E., MD, MSc
Other Authors: Dangas, George, MD, PhD , Leon, Martin B., MD , Smith, Craig, MD , Nesto, Richard, MD , Buse, John B., MD, PhD , Cohen, David J., MD, MSc , Mahoney, Elizabeth, ScD , Sleeper, Lynn, ScD , King, Spencer, MD , Domanski, Michael, MD , McKinlay, Sonja, PhD , Fuster, Valentin, MD, PhD
Format: Electronic Article Electronic Article
Language: English
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Quelle: Alma/SFX Local Collection
Publisher: New York, NY: Mosby, Inc
ID: ISSN: 0002-8703
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recordid: cdi_proquest_miscellaneous_70250323
title: Design of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial
format: Article
creator:
  • Farkouh, Michael E., MD, MSc
  • Dangas, George, MD, PhD
  • Leon, Martin B., MD
  • Smith, Craig, MD
  • Nesto, Richard, MD
  • Buse, John B., MD, PhD
  • Cohen, David J., MD, MSc
  • Mahoney, Elizabeth, ScD
  • Sleeper, Lynn, ScD
  • King, Spencer, MD
  • Domanski, Michael, MD
  • McKinlay, Sonja, PhD
  • Fuster, Valentin, MD, PhD
subjects:
  • Abridged Index Medicus
  • Angioplasty, Balloon, Coronary
  • Biological and medical sciences
  • Cardiology. Vascular system
  • Cardiovascular
  • Care and treatment
  • Coronary Artery Bypass
  • Coronary Disease - therapy
  • Coronary vessels
  • Diabetes
  • Diabetes Complications
  • Diabetes therapy
  • Diabetes. Impaired glucose tolerance
  • Diabetics
  • Drug therapy
  • Drug-Eluting Stents
  • Endocrine pancreas. Apud cells (diseases)
  • Endocrinopathies
  • Epidemiologic Research Design
  • Etiopathogenesis. Screening. Investigations. Target tissue resistance
  • Heart attacks
  • Humans
  • Medical sciences
  • Mortality
  • Myocardial Revascularization
  • Prospective Studies
  • Studies
ispartof: The American heart journal, 2008, Vol.155 (2), p.215-223
description: Background Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. The FREEDOM Trial is designed to determine whether CABG or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients. Study Design The FREEDOM Trial is a multicenter, open-label prospective randomized superiority trial of PCI versus CABG in at least 2000 diabetic patients in whom revascularization is indicated. Consenting diabetic patients with multivessel disease will be randomized on a 1:1 basis to either CABG or multivessel stenting using DESs and observed at 30 days, 1 year, and annually for up to 5 years. At the discretion of the primary physician or interventionalists, patients randomized to the PCI/DES arm will receive any approved DESs. The primary outcome measure is the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Patients will be observed for a mean of 4 years. Implications At present, coronary revascularization with CABG surgery is the treatment of choice in diabetic patients with multivessel coronary artery disease. Drug-eluting stents have shown promising preliminary results in the diabetic population. The FREEDOM Trial is an international study designed to define the optimal revascularization strategy for the diabetic patient with multivessel coronary disease.
language: eng
source: Alma/SFX Local Collection
identifier: ISSN: 0002-8703
fulltext: fulltext
issn:
  • 0002-8703
  • 1097-6744
url: Link


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titleDesign of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial
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creatorFarkouh, Michael E., MD, MSc ; Dangas, George, MD, PhD ; Leon, Martin B., MD ; Smith, Craig, MD ; Nesto, Richard, MD ; Buse, John B., MD, PhD ; Cohen, David J., MD, MSc ; Mahoney, Elizabeth, ScD ; Sleeper, Lynn, ScD ; King, Spencer, MD ; Domanski, Michael, MD ; McKinlay, Sonja, PhD ; Fuster, Valentin, MD, PhD
creatorcontribFarkouh, Michael E., MD, MSc ; Dangas, George, MD, PhD ; Leon, Martin B., MD ; Smith, Craig, MD ; Nesto, Richard, MD ; Buse, John B., MD, PhD ; Cohen, David J., MD, MSc ; Mahoney, Elizabeth, ScD ; Sleeper, Lynn, ScD ; King, Spencer, MD ; Domanski, Michael, MD ; McKinlay, Sonja, PhD ; Fuster, Valentin, MD, PhD
descriptionBackground Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. The FREEDOM Trial is designed to determine whether CABG or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients. Study Design The FREEDOM Trial is a multicenter, open-label prospective randomized superiority trial of PCI versus CABG in at least 2000 diabetic patients in whom revascularization is indicated. Consenting diabetic patients with multivessel disease will be randomized on a 1:1 basis to either CABG or multivessel stenting using DESs and observed at 30 days, 1 year, and annually for up to 5 years. At the discretion of the primary physician or interventionalists, patients randomized to the PCI/DES arm will receive any approved DESs. The primary outcome measure is the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Patients will be observed for a mean of 4 years. Implications At present, coronary revascularization with CABG surgery is the treatment of choice in diabetic patients with multivessel coronary artery disease. Drug-eluting stents have shown promising preliminary results in the diabetic population. The FREEDOM Trial is an international study designed to define the optimal revascularization strategy for the diabetic patient with multivessel coronary disease.
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subjectAbridged Index Medicus ; Angioplasty, Balloon, Coronary ; Biological and medical sciences ; Cardiology. Vascular system ; Cardiovascular ; Care and treatment ; Coronary Artery Bypass ; Coronary Disease - therapy ; Coronary vessels ; Diabetes ; Diabetes Complications ; Diabetes therapy ; Diabetes. Impaired glucose tolerance ; Diabetics ; Drug therapy ; Drug-Eluting Stents ; Endocrine pancreas. Apud cells (diseases) ; Endocrinopathies ; Epidemiologic Research Design ; Etiopathogenesis. Screening. Investigations. Target tissue resistance ; Heart attacks ; Humans ; Medical sciences ; Mortality ; Myocardial Revascularization ; Prospective Studies ; Studies
ispartofThe American heart journal, 2008, Vol.155 (2), p.215-223
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descriptionBackground Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. The FREEDOM Trial is designed to determine whether CABG or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients. Study Design The FREEDOM Trial is a multicenter, open-label prospective randomized superiority trial of PCI versus CABG in at least 2000 diabetic patients in whom revascularization is indicated. Consenting diabetic patients with multivessel disease will be randomized on a 1:1 basis to either CABG or multivessel stenting using DESs and observed at 30 days, 1 year, and annually for up to 5 years. At the discretion of the primary physician or interventionalists, patients randomized to the PCI/DES arm will receive any approved DESs. The primary outcome measure is the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Patients will be observed for a mean of 4 years. Implications At present, coronary revascularization with CABG surgery is the treatment of choice in diabetic patients with multivessel coronary artery disease. Drug-eluting stents have shown promising preliminary results in the diabetic population. The FREEDOM Trial is an international study designed to define the optimal revascularization strategy for the diabetic patient with multivessel coronary disease.
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25Prospective Studies
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titleDesign of the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial
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2Biological and medical sciences
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5Care and treatment
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7Coronary Disease - therapy
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9Diabetes
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12Diabetes. Impaired glucose tolerance
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volume155
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abstractBackground Prior randomized trials suggested that revascularization of diabetic patients by coronary artery bypass grafting (CABG) produced results superior to balloon angioplasty. The introduction of drug-eluting stents (DESs) calls into question the relevance of past studies to the current era. The FREEDOM Trial is designed to determine whether CABG or percutaneous coronary intervention (PCI) is the superior approach for revascularization of diabetic patients. Study Design The FREEDOM Trial is a multicenter, open-label prospective randomized superiority trial of PCI versus CABG in at least 2000 diabetic patients in whom revascularization is indicated. Consenting diabetic patients with multivessel disease will be randomized on a 1:1 basis to either CABG or multivessel stenting using DESs and observed at 30 days, 1 year, and annually for up to 5 years. At the discretion of the primary physician or interventionalists, patients randomized to the PCI/DES arm will receive any approved DESs. The primary outcome measure is the composite of all-cause mortality, nonfatal myocardial infarction, or stroke. Patients will be observed for a mean of 4 years. Implications At present, coronary revascularization with CABG surgery is the treatment of choice in diabetic patients with multivessel coronary artery disease. Drug-eluting stents have shown promising preliminary results in the diabetic population. The FREEDOM Trial is an international study designed to define the optimal revascularization strategy for the diabetic patient with multivessel coronary disease.
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