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FREEDOM TRIAL |
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| Problem | CABG V. PCI in diabetics with multivessel disease |
| Format | Randomised, non-blinded |
| Treatment | Revascularisation by CABG |
| Control | PCI |
| Population | 1900 |
| Inclusion criteria | Diabetics Indication for revascularisation as by angina pectoralis or ischaemic ECG changes >1 major epicardial vessel with >69% stenosis in 1> coronary artery territory |
| Exclusion criteria | Acute STEMI past 72h CCF Killip class III/IV CABG or PCI past 6/12 Previous cardiac valve surgery Simultaneous surgical procedure CK >2 or CK-MB >reference range Stroke past 6 months or previous stroke with residual deficit Enrolled in other clinical trial currently |
| Follow-up | Median 3.8y |
| Primary endpoint | Composite of death from any cause, non-fatal MI and non-fatal stroke |
| Secondary endpoint(s) | MACCE at 30 days, 1, 2 and 3 years Quality of life at 30 days, 6 months, 1, 2 and 3 years Cost efficacy |
| Details | . |
| Brief summary: | CABG superior to PCI for multivessel disease in DM |
| PAPER: Strategies for multivessel revascularisation in patients with diabetes | |
|---|---|
| Date | 4 Nov 2012 |
| Journal | N Engl J Med 2012 DOI: 10.1056/NEJMoa1211585 |
| Information | PCI V. CABG in Diabetics with mutlivessel disease -Significant decrease in composite endpoint of Death/MI/Stroke at 5y with CABG (18.7%) V. PCI 26.6% -Above endpoint more frequent in CABG (42 patients) than CABG (26 patients) at 30 days -Significant decrease in all cause morality with CABG (10.9%) V. PCI (16.3%) at 5y -Significant decrease in MI with CABG (6.0%) V. PCI (13.9%) -Significantly decrease in Stroke with PCI (2.4%) V. CABG (5.2%) -At 30 days no significant difference in rates of major adverse cardiovascular or cerebrovascular event -At 1 year significant increase in rates of major adverse cardiovascular and cerebrovascular events with PCI (16.8%) V. 11.8%. Most of this consitutes repeat revascularisation (12.6% V 4.8% respectively) -Benefit to CABG demonstrated across all complexities of coronary artery stenosis anatomy as measured by SYNTAX score -No significant difference between outcomes in subanalysis of paclitaxel V. sacrolimus eluting stents Overall effect - diabetics requiring revascularisation of >1 lesion >69% stenosis in a major epicardial vessel require CABG |