FREEDOM Trial

The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease trial was a post hoc analysis comparing outcomes in patients receiving dual antiplatelet therapy or aspirin alone after CABG.

Design: Randomized, open-label, parallel assignment

Patients: 795

Centers: Multicenter

Countries: 14

Results: At 5 years, there was no significant difference in the primary composite outcome of all-cause mortality, nonfatal MI or stroke (DAPT group, 12.6%; aspirin group, 16%; adjusted HR = 0.83; 95% CI, 0.54-1.27). There were also no differences between the groups in major bleeding (DAPT group, 5.7%; aspirin group, 5.6%; HR = 1; 95% CI, 0.5-1.99), blood transfusions (DAPT group, 4.5%; aspirin group, 4.8%; HR = 1.09; 95% CI, 0.51-2.34) or hospitalization for bleeding (DAPT group, 3.3%, aspirin group. 2.6%; HR = 0.85; 95% CI, 0.34-2.17).

Original Publications:
van Diepen S, et al. J Am Coll Cardiol. 2017;doi:10.1016/j.jacc.2016.10.043.

Healio/Cardiology News Coverage:
DAPT, aspirin monotherapy confer similar outcomes in patients with diabetes after CABG

Summary: Evaluated coronary artery bypass grafting (CABG) versus percutaneous coronary intervention (PCI) in diabetic patients with 3-vessel coronary disease. The primary composite endpoint of all cause mortality, non-fatal MI and non-fatal stroke was  reduced with CABG, but not PCI at 5 years. There was decreased mortality and MI in CABG patients, however increased stroke.

Original Publication:

N Engl J Med 2012 DOI: 10.1056/NEJMoa1211585

http://www.ncbi.nlm.nih.gov/pubmed/19502645

Eponym: Future REvascularization Evaluation in patients with Diabetes Mellitus: Optimal management of Multivessel disease trial