Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease IDE #G040164
Study Description
This is a multi-center, two-arm, open label prospective randomized superiority trial with equal allocation (n=2400 patients) performed in the United States, Canada, Europe, South America and Australia.
This NIH funded trial will compare two groups of patients who have diabetes mellitus and documented coronary artery disease and who are referred for coronary revascularization. After meeting study eligibility, patients will be randomized to either stent placement or Coronary Artery Bypass Grafting (CABG).
Currently, CABG is the recommended treatment for diabetic patients with multi-vessel coronary artery disease. However, studies performed that resulted in the development of this recommendation compared CABG to either angioplasty or bare metal stents. Stenting has been proven to be more effective than angioplasty, but the bare metal stents that were used in these studies have a re-stenosis rate of anywhere between 30% and 50%. After the invention of drug-eluting stents (DES), which decreased re-stenosis by over 30%, no studies have been performed to examine the short and long-term effectiveness of multi-vessel stenting with drug eluting stents.
Objectives
Primary Objective(s):The primary objective of the trial is to assess the long-term effectiveness of multi-vessel percutaneous coronary intervention with drug-eluting stents (PCI/stenting) compared to CABG in preventing all cause mortality, nonfatal myocardial infarction or stroke at the end of a 5 year follow-up period (average follow-up 4 years).
Secondary Objective(s):The most important secondary objective of the trial will be to assess the effectiveness of PCI/stenting versus CABG with respect to one-year Major Adverse Cardiac and Cerebrovascular Event (MACCE) rates. MACCE will include one or more of the following: death, myocardial infarction, stroke, or repeat revascularization.
Additionally, a Medical Billing Release Form will be presented to those patients willing to allow the study to do an economic analysis of the costs of stent implantation vs. CABG and quality of life questionnaires will be completed. Both of these additional aspects of the protocol, and others, are intended to create a more accurate and fully informed recommendation to diabetic patients who are facing coronary revascularization.
Contact Information
Status:
Name, Phone, Email:
Renee Neuharth, BS
801-587-4877
Renee.Neuharth@hsc.utah.edu
Principle Investigator:
Brad Burlew, M.D.
Please Note:
Study Coordinators and Research Nurses cannot give medical advice over the phone. Telephone numbers are provided for obtaining additional information on specific clinical research trials only. If you have specific questions which require clinical expertise, please call your primary care physician. If you do not have a primary care physician, we can help you find a University of Utah doctor or clinic location to meet your health care needs.
Although the studies described on this Web site may have potential benefits as described, the University of Utah and its physicians and affiliated hospitals cannot and do not guarantee or promise that you will receive any benefits from participating in a study.
Participant Eligibility
Inclusion Criteria:[NOTE TO PATIENTS: You may want to copy the following information and present it to your Doctor to determine your eligibility to participate in this study]
Patients included in this study must meet the following criteria in order to be considered for entry and randomization:
- Male or Female age 18 years or older
- Diabetes Mellitus (Type 1 or Type 2): Defined according to the American Diabetes Association as history of either:
a. presence of classic symptoms of diabetes mellitus with unequivocal elevation of plasma glucose (2-hour post-prandial or random of >200 mg/dL (11mmol/L) or
b. fasting plasma glucose elevation on more than 1 occasion of at least 126 mg/dL (7mmol/L);
And currently undergoing pharmacological or non-pharmacological treatment. - Angiographically confirmed multivessel CAD [critical (>70%) lesions in at least two major epicardial vessels and in at least two separate coronary artery territories (LAD, LCX, RCA)].
- Angiographic characteristics amenable to both PCI/DES and CABG.
- Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischemia.
- Willing to comply with all follow-up required study visits.
- Signed and received copy of informed consent.
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema) at the time of enrollment.
- Prior CABG surgery.
- Prior Valve surgery.
- Prior PCI with stent implantation within 6 months.
- Previous stroke within 6 months or patients with stroke at more than 6 months with significant residual neurologic involvement, as reflected in a Rankin Score > 1.
- Prior history of significant bleeding (within the previous 6 months) that might be expected to occur during CABG or PCI/DES related anticoagulation.
- In-stent restenosis of a target vessel.
- Two or more chronic total occlusions in major coronary territories.
- Left main stenosis (at least 50% diameter stenosis).
- Acute ST-elevation MI (Q-wave) within 72 hours prior to enrollment requiring revascularization.
- Abnormal creatine kinase (CK > 2x normal); or abnormal CK-MB levels at time of randomization.
- Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g.
valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stent). - Contraindication to either CABG or PCI/DES because of a coexisting clinical condition.
- Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
- Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine.
- Dementia with a Mini Mental Status Examination (MMSE) score of <20.
- Extra-cardiac illness that is expected to limit survival to less than 5 years; e.g. oxygen-dependent, chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease.
- Suspected pregnancy. A pregnancy test (urine or serum) will be administered pre-randomization to all women not clearly menopausal.
- Concurrent enrollment in another clinical trial.
- Geographically inaccessible for follow-up visits required by protocol.
