What is the current status of the cardiovascular freedom trial for a patient with a history of cardiovascular events, diabetes, and hypertension?

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Last updated: January 16, 2026 • View editorial policy

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The FREEDOM Trial: Completed Study with Long-Term Follow-Up Data Available

The FREEDOM (Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease) trial is a completed randomized controlled trial that demonstrated coronary artery bypass grafting (CABG) is superior to percutaneous coronary intervention (PCI) with drug-eluting stents for patients with diabetes and multivessel coronary artery disease. 1, 2

Trial Design and Completion Status

  • The FREEDOM trial randomized 1,900 patients with diabetes mellitus and multivessel coronary artery disease to either PCI with drug-eluting stents (sirolimus-eluting or paclitaxel-eluting stents) or CABG, all on a background of optimal medical therapy 2

  • The original trial completed with a median follow-up of 3.8 years, reporting results in 2012 1

  • Extended follow-up data became available through the FREEDOM Follow-On study, which enrolled 943 patients (49.6% of the original cohort) from 25 of the 140 original centers, with median follow-up extending to 7.5 years (range 0 to 13.2 years) 2

Primary Findings at Original Trial Completion

  • At 5 years, CABG significantly reduced all-cause mortality compared to PCI (P=0.049) and myocardial infarction (P<0.001) 1

  • The trial found borderline lower mortality after CABG than after PCI at 5 years (relative risk 0.63; P=0.049), though the predefined cutoff for the primary endpoint was P=0.044, and the trial was not specifically powered for mortality 1

  • Approximately 30% of enrolled patients had recent acute coronary syndrome (interval unspecified), though no specific subgroup analysis was performed for this population 1

Long-Term Follow-Up Results

  • During the entire follow-up period (including both original trial and extended follow-up), there were 314 total deaths: 204 deaths during the original trial and 110 deaths during the FREEDOM Follow-On study 2

  • All-cause mortality rate was significantly higher in the PCI group (24.3%, 159 deaths) compared to the CABG group (18.3%, 112 deaths; hazard ratio 1.36; 95% CI 1.07-1.74; P=0.01) over the entire follow-up period 2

  • In the extended follow-up cohort of 943 patients, all-cause mortality was 23.7% (99 deaths) in the PCI group versus 18.7% (72 deaths) in the CABG group (hazard ratio 1.32; 95% CI 0.97-1.78; P=0.076) 2

Clinical Impact and Guideline Integration

  • The FREEDOM trial results influenced the 2014 AHA/ACC guidelines for non-ST-elevation acute coronary syndromes, which state that CABG is superior to PCI in reducing major adverse cardiovascular events in diabetic patients with multivessel disease 1

  • Bayesian analysis of FREEDOM combined with prior randomized controlled trials demonstrated with 99.9% probability that mortality is at least 10% lower after CABG, with 96.8% probability that mortality is at least 30% lower after CABG compared to PCI in diabetic patients with multivessel disease 1

  • The trial's findings are particularly relevant for patients with more severe and complex coronary artery disease, as demonstrated by the SYNTAX trial showing CABG superiority increases with disease complexity 1

Important Caveats for Patient Selection

  • The FREEDOM trial specifically enrolled patients with 2- or 3-vessel coronary artery disease, not single-vessel disease 1

  • Patients with less severe and complex coronary disease may have similar outcomes with PCI versus CABG, making individual anatomic assessment critical 1

  • The trial used first-generation drug-eluting stents (sirolimus-eluting and paclitaxel-eluting); newer-generation stents were not evaluated 2

  • All patients received optimal medical therapy as background treatment, making this a comparison of revascularization strategies on top of guideline-directed medical management 2

Distinction from Other "FREEDOM" Studies

  • Do not confuse the FREEDOM cardiovascular outcomes trial (revascularization in diabetes) with the FREEDOM trial testing continuous subcutaneous exenatide infusion (ITCA 650), a GLP-1 receptor agonist formulation 3

  • The GLP-1 receptor agonist FREEDOM trial reported dissimilar results to prior GLP-1 trials and should not influence considerations about approved GLP-1 formulations 3

References

1
Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

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Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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