To compare 5 year mortality in diabetic patients with multivessel coronary disease who are randomized to either coronary artery surgery (CABG) or to percutaneous coronary stenting.

Condition	Treatment or Intervention
Cardiovascular Diseases Coronary Disease Diabetes Mellitus Heart Diseases	Procedure: Coronary artery bypass  Procedure: Percutaneous coronary intervention

BACKGROUND: The study addresses a critically important problem, that is, how to best revascularize diabetic patients with multivessel coronary artery disease (CAD). With the prevalence of CAD and diabetes increasing at alarming rates, direction for optimal revascularization comes largely from the Bypass Angioplasty Revascularization Investigation (BARI) trial. At five years, BARI showed 15 excess deaths for every 100 diabetic patients revascularized by percutaneous techniques (PCI) compared to bypass surgery (CABG) and at 7 years this widened to more than 20. These findings provide compelling evidence for some practitioners 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 trials. 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 patients. New developments in PCI should translate to improved prognosis to offset the advantage of CABG seen in BARI. 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 opportunity in time exists to gather the evidence to support the strategy that provides optimal revascularization in diabetics.

DESIGN NARRATIVE: FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) is a multicenter, prospective, randomized clinical trial comparing coronary artery bypass surgery (CABG) with percutaneous coronary stenting using the Sirolimus-eluting stent in diabetic patients with multivessel disease. The main objective of the study is to compare a multivessel stenting strategy using Sirolimus-eluting stents with CABG with respect to mortality in 5 years of follow-up. The study population will consist of 2300 patients (1150/arm) with diabetes mellitus diagnosed according to the American Diabetes Association, and multivessel coronary artery disease (CAD) (2 or more stenotic lesions in at least 2 major epicardial coronary arteries), amenable to either PCI with stenting or surgical revascularization. All subjects will be screened to ensure that all inclusion and exclusion criteria are fulfilled prior to study entry. A written informed consent will be obtained prior to enrollment in the study. Patients who meet the eligibility criteria will be randomized on a 1:1 basis either to CABG or multivessel stenting using Sirolimus-eluting stents. The primary outcome of the study is the difference in mortality rates between the stent group and the CABG group over the 5-year period. The following secondary endpoints will be assessed: 1) survival functions over years 1, 2, 3 and 4; 2) individual components of major adverse cardiovascular events (MACCE) in-hospital at 30 days, 6 months and 12 months; 3) quality of life pre- and post-randomization every 6 months up to 5 years; 4) neuro-cognitive function pre-procedure and 6 months, 1 year and 5 years post-procedure; and 5) cost-effectiveness analyses, hospital length of stay, resource utilization, repeat hospitalization, and repeat revascularization events. Patients will be recruited over the course of 18 months at 100 clinical sites

Genders Eligible for Study:  Both

Criteria

No eligibility criteria

Study chairs or principal investigators

Valentin Fuster,  Mount Sinai School of Medicine of NYU   

Study ID Numbers:  162
Record last reviewed:  July 2004
Record first received:  July 1, 2004
ClinicalTrials.gov Identifier:  NCT00086450
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-10-27