Diabetes mellitus Nutritional, Metabolic, Endocrine Unspecified diabetes mellitus
Conditions
Interventions
Multi-centre, randomised, prospective comparison with predefined endpoints analysis at 30 days, 6 months, 1-year (primary endpoint), 2-year and 5-year follow-up.
Coronary artery bypass grafting (CABG
Sponsors
Hammersmith Hospitals NHS Trust (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General inclusion criteria: 1. Patients with type I or type II diabetes mellitus (no medication, oral medication, insulin therapy) defined by World Health Organization (WHO) criteria for those patients not on medical treatment, and 2. Coronary stenoses of greater than 50% severity in greater than or equal to two or more coronary arteries or single significant stenosis in proximal left anterior descending (LAD) before the first septal branch or complex bifurcation lesions in any major epicardial vessel, and 3. Stable (Canadian Cardiovascular Society class I - IV) or unstable (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC alongside any intensity of treatment [1 to 3]) angina pectoris or patients with anginal equivalent and evidence of ischaemia (e.g. treadmill exercise test, radionuclide perfusion scanning, stress echocardiography), and 4. Suitable for revascularisation using optimal PCI (including abciximab and stenting) or up-to-date CABG 5. Written informed consent 6. Agreement between cardiothoracic surgeon and cardiologist that the selected case fulfils both inclusion and exclusion criteria 7. Age greater than 18 years and less than 80 years, either sex Angiographic inclusion criteria: 1. Multivessel disease with one or more significant stenoses in at least two major epicardial coronary arteries (LAD, left circumflex [CX] and right coronary artery [RCA]) or single vessel complex disease defined as: 1.1. A proximal LAD lesion before the first septal branch, or 1.2. A bifurcation lesion involving a side branch and a main epicardial vessel provided they supply different territories 2. Total occlusions of one major epicardial vessel or side branch can be included as long as one other major vessel has a significant stenosis 3. A significant stenosis is defined as a stenosis of at least 50% but less than 100% in luminal diameter (in at least one view, on visual interpretation or by qualitative comparative analysis [QCA]) 4. Stenting in lesions with a bifurcation, thrombus, calcification or very long obstruction (greater than 20 mm) is left to the operator?s discretion 5. The number of stents implanted per patient is not restricted
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Inability to consent 2. Current participation in another study 3. Greater than 80 years and less than 18 years 4. Congenital heart disease 5. History of previous PCI or CABG 6. When complete follow up over a period of two years is, in the judgement of the investigator, unlikely 7. Inadequate quality of saphenous vein or arterial conduit material 8. Serum creatinine of greater than 250 iu/l or episode of renal dialysis within the 30 days prior to randomisation. However, those on established dialysis greater than six months are eligible for inclusion 9. Q-wave myocardial infarction within the six weeks prior to randomisation 10. Significant valve disease likely to result in requirement for surgery now or within the next five years 11. Other disease shortening life expectancy to less than 12 months 12. Persistence of severe uncontrolled hypertension (blood pressure [BP] greater than 200/120) within the 48 hours prior to randomisation 13. Administration of oral anticoagulation within seven days of planned revascularisation or International normalised ratio (INR) of greater than or equal to 1.4 with ongoing oral anti-coagulation treatment 14. Blood dyscrasia (platelets less than 100, haemoglobin [Hb] less than 8 g/dl, INR greater than 1.4, activated partial thromboplastin time [APTT] greater than 2 x normal, leukocyte count less than 3.5 x 10^9/l, neutrophil count less than 1 x 10^9/l) 15. Intolerance or contraindication to aspirin, clopidogrel or abciximab Angiographic exclusion criteria: 1. Left main stem stenosis of 50% or more 2. Intention to treat more than one totally occluded major epicardial vessel
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of the composite of all-cause death, non-fatal MI, non-fatal stroke at one year. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. All individual components of the primary and major secondary endpoints at 30 days, six months, two years and five years 2. Death/MI/target vessel revascularisation (TVR) at six months for bare metal versus sirolimus stents 3. Death/MI/coronary vascular accident (CVA)/further revascularisation at one year for sirolimus stents versus CABG 4. Severe bleeding complications at 30 days 5. New requirement for permanent dialysis 6. Neurological morbidity 7. Quality of life (measured with the EuroQoL (EQ5D) and cognitive assessment questionnaires), assessed at screening, 30-day and six-month follow-up. The EQ5D will also be assessed at 12 months, two years and five years follow-up. 8. Cost difference between treatments 9. Change in left ventricular (LV) function | — |
Countries
United Kingdom
Outcome results
None listed