FREEDOM
Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease
Clinical Question
Population
Patients with diabetes mellitus (type 1 or type 2) and angiographically confirmed multivessel coronary artery disease (stenosis ≥70% in ≥2 major epicardial vessels) at 140 international centers.
PCI with drug-eluting stents (sirolimus-eluting or paclitaxel-eluting) plus optimal medical therapy
CABG plus optimal medical therapy
Primary Endpoint
Composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke at 5 years
Key Findings
The primary endpoint occurred in 26.6% of PCI patients vs 18.7% of CABG patients at 5 years (p=0.005).
All-cause mortality was significantly lower with CABG (10.9% vs 16.3%; p=0.049).
Myocardial infarction rates were lower with CABG (6.0% vs 13.9%; p<0.001).
Stroke was higher in the CABG group (5.2% vs 2.4%; p=0.03).
The benefit of CABG was consistent regardless of SYNTAX score tertile.
Impact on Clinical Practice
Guideline Impact
Limitations
First-generation drug-eluting stents were predominantly used; contemporary stents with thinner struts and more biocompatible polymers may improve PCI outcomes.
The trial took over 8 years to complete due to slow enrollment, during which stent technology evolved significantly.
Stroke rates were higher with CABG, which may influence shared decision-making for patients particularly concerned about cerebrovascular events.
How Does This Trial Apply to Your Case?
Clinical trials inform guidelines, but every patient is unique. Our Heart Team evaluates how landmark evidence applies to your specific anatomy, risk profile, and preferences.
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