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Coronary Disease2012New England Journal of Medicine

FREEDOM

Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease

Sample Size
1,900
Study Design
Multicenter, international, randomized, superiority trial
Year Published
2012
Category
Coronary Disease

Clinical Question

Is CABG superior to PCI with drug-eluting stents in patients with diabetes and multivessel coronary artery disease?

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.

Intervention

PCI with drug-eluting stents (sirolimus-eluting or paclitaxel-eluting) plus optimal medical therapy

Control

CABG plus optimal medical therapy

Primary Endpoint

Composite of all-cause mortality, nonfatal myocardial infarction, or nonfatal stroke at 5 years

Key Findings

1

The primary endpoint occurred in 26.6% of PCI patients vs 18.7% of CABG patients at 5 years (p=0.005).

2

All-cause mortality was significantly lower with CABG (10.9% vs 16.3%; p=0.049).

3

Myocardial infarction rates were lower with CABG (6.0% vs 13.9%; p<0.001).

4

Stroke was higher in the CABG group (5.2% vs 2.4%; p=0.03).

5

The benefit of CABG was consistent regardless of SYNTAX score tertile.

Impact on Clinical Practice

FREEDOM established CABG as the preferred revascularization strategy for diabetic patients with multivessel coronary artery disease, providing Level 1 evidence for a clinical scenario that affects millions of patients worldwide. The survival advantage of CABG was striking and consistent, driven by reductions in both death and myocardial infarction. The trial addressed a critical knowledge gap, as diabetic patients had been underrepresented in prior PCI-versus-CABG trials. The pathophysiology of diabetic coronary disease, characterized by diffuse, multivessel involvement with accelerated progression, favors the complete revascularization and bypass of future lesions that CABG provides. While the higher stroke rate with CABG was a concern, the overall net clinical benefit strongly favored surgery. FREEDOM remains the definitive trial guiding revascularization decisions in diabetic patients and has been widely cited in international guidelines as the basis for recommending CABG in this population.

Guideline Impact

FREEDOM is the basis for the ACC/AHA Class I recommendation (Level of Evidence A) for CABG over PCI in patients with diabetes and multivessel coronary artery disease. ESC/EACTS guidelines similarly recommend CABG as the preferred strategy in this population.

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.

Reviewed by Kunal U. Gurav, MD
Echocardiography & Nuclear Cardiology

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