Ignite Creation Date:
2024-05-05 @ 11:34 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00086450
Status:
UNKNOWN
Last Update Posted:
2017-02-06
First Post:
2004-07-01
Brief Title:
Comparison of Two Treatments for Multivessel Coronary Artery Disease in Individuals With Diabetes FREEDOM
Sponsor:
Valentin Fuster
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
Future Revascularization Evaluation in Patients With Diabetes Mellitus Optimal Management of Multivessel Disease FREEDOM
Status:
UNKNOWN
Status Verified Date:
2016-12
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
BACKGROUND
The study addresses the critically important problem of how to best revascularize diabetic individuals with multivessel CAD CAD and diabetes diagnoses are increasing at alarming rates and much of the information regarding optimal revascularization comes from the Bypass Angioplasty Revascularization Investigation BARI study After five years data from the BARI study showed 15 excess deaths for every 100 diabetic participants revascularized by percutaneous coronary intervention PCI compared to CABG and at 7 years there were more than 20 deaths These findings provide compelling evidence for some physicians to conclude that diabetic patients with multivessel disease in need of revascularization are best handled by CABG But a consensus has not yet been reached because these findings have not been uniformly confirmed by registries and other studies With the recent introduction of coated stents that significantly reduce or eliminate restenosis a prevailing belief is that adequate revascularization can be achieved by PCI even in diabetic individuals New developments in percutaneous techniques should translate to improved prognosis to offset the advantage of CABG seen in the BARI study Since these new drug eluting stents are not yet approved and are not likely to be on the market for several years a small window of time exists to gather the evidence to support the strategy that provides optimal revascularization in diabetic individuals
DESIGN NARRATIVE
FREEDOM Future Revascularization Evaluation in Patients with Diabetes Mellitus Optimal Management of Multivessel Disease is a multicenter two-arm open label prospective randomized superiority trial with equal allocation of 5 years duration with a minimum of 3 years of follow-up The main objective of the study is to evaluate whether PCI with drug-eluting stenting PCIDES is more or less effective than the existing standard of care CABG The study population will consist of 2400 adults with diabetes mellitus Type 1 or Type 2 with angiographically confirmed multivessel CAD and morphology amenable to either PCI or CABG with indication for revascularization based upon symptoms or angina andor objective evidence of myocardial ischemia Patients who consent will be randomized on a 11 basis either to CABG or multivessel stenting using drug-eluting stents and followed at 30 days 1 year and then annually for at least 3 years but up to 5 years A registry of 2000 patients will also be recruited concurrently comprised of eligible non-consenting patients for the randomized trial Eligible patients will be randomized to receive either CABG or multivessel stenting using drug-eluting stents Patients randomized to the PCIDES arm will receive at the discretion of the primary physician or interventionalists either CYPHER Sirolimus eluting stent Cordis Corporation Warren NJ USA or the TAXUS paclitaxel-eluting stent Boston Scientific Corporation Natick MA USA However it is intended that only one type of drug-eluting stent be used in a given patient during the course of the trial The primary outcome of the study is the composite of all-cause mortality nonfatal myocardial infarction and stroke at the end of the 5-year patient accrual and follow-up period minimum follow-up is 3 years The main secondary endpoint that will be assessed is the 1-year major adverse cardiac and cerebrovascular event MACCE rates including the first of one of the following death myocardial infarction stroke or repeat revascularization Additional secondary endpoints include all-cause and cardiovascular mortality at 1 2 and 3 years rates of individual MACCE endpoints at 30 days post-procedure quality of life at 30 days 6 months and annually post-procedure long term costs and cost-effectiveness
The study addresses the critically important problem of how to best revascularize diabetic individuals with multivessel CAD CAD and diabetes diagnoses are increasing at alarming rates and much of the information regarding optimal revascularization comes from the Bypass Angioplasty Revascularization Investigation BARI study After five years data from the BARI study showed 15 excess deaths for every 100 diabetic participants revascularized by percutaneous coronary intervention PCI compared to CABG and at 7 years there were more than 20 deaths These findings provide compelling evidence for some physicians to conclude that diabetic patients with multivessel disease in need of revascularization are best handled by CABG But a consensus has not yet been reached because these findings have not been uniformly confirmed by registries and other studies With the recent introduction of coated stents that significantly reduce or eliminate restenosis a prevailing belief is that adequate revascularization can be achieved by PCI even in diabetic individuals New developments in percutaneous techniques should translate to improved prognosis to offset the advantage of CABG seen in the BARI study Since these new drug eluting stents are not yet approved and are not likely to be on the market for several years a small window of time exists to gather the evidence to support the strategy that provides optimal revascularization in diabetic individuals
DESIGN NARRATIVE
FREEDOM Future Revascularization Evaluation in Patients with Diabetes Mellitus Optimal Management of Multivessel Disease is a multicenter two-arm open label prospective randomized superiority trial with equal allocation of 5 years duration with a minimum of 3 years of follow-up The main objective of the study is to evaluate whether PCI with drug-eluting stenting PCIDES is more or less effective than the existing standard of care CABG The study population will consist of 2400 adults with diabetes mellitus Type 1 or Type 2 with angiographically confirmed multivessel CAD and morphology amenable to either PCI or CABG with indication for revascularization based upon symptoms or angina andor objective evidence of myocardial ischemia Patients who consent will be randomized on a 11 basis either to CABG or multivessel stenting using drug-eluting stents and followed at 30 days 1 year and then annually for at least 3 years but up to 5 years A registry of 2000 patients will also be recruited concurrently comprised of eligible non-consenting patients for the randomized trial Eligible patients will be randomized to receive either CABG or multivessel stenting using drug-eluting stents Patients randomized to the PCIDES arm will receive at the discretion of the primary physician or interventionalists either CYPHER Sirolimus eluting stent Cordis Corporation Warren NJ USA or the TAXUS paclitaxel-eluting stent Boston Scientific Corporation Natick MA USA However it is intended that only one type of drug-eluting stent be used in a given patient during the course of the trial The primary outcome of the study is the composite of all-cause mortality nonfatal myocardial infarction and stroke at the end of the 5-year patient accrual and follow-up period minimum follow-up is 3 years The main secondary endpoint that will be assessed is the 1-year major adverse cardiac and cerebrovascular event MACCE rates including the first of one of the following death myocardial infarction stroke or repeat revascularization Additional secondary endpoints include all-cause and cardiovascular mortality at 1 2 and 3 years rates of individual MACCE endpoints at 30 days post-procedure quality of life at 30 days 6 months and annually post-procedure long term costs and cost-effectiveness
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01 HL71988 | US NIH GrantContract | None | httpsreporternihgovquickSearchU01HL071988 |
| U01HL071988 | NIH | None | None |