FREEDOM TRIAL

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