6/28/23, 10:40 PM FREEDOM Pathway Feedback Search Clinical Topics Home Studies FREEDOM FREEDOM Disease Disease Disease Coronary artery disease Diabetes mellitus type 1 Diabete Trial question What is the role of PCI with drug-eluting stents in patients with diabetes and multivessel coronary artery disease? Study design Multi-center Open label RCT Population Characteristics of study participants 29.0% female N = 1900 71.0% male 1900 patients (544 female, 1356 male) Inclusion criteria: patients with diabetes and multivessel coronary artery disease Key exclusion criteria: severe congestive HF, prior CABG surgery, prior cardiac valve surgery, prior PCI with stent implantation within 6 months, previous stroke within 6 months, history of significant bleeding, or dementia Interventions N=953 percutaneous coronary artery intervention (sirolimus-eluting and paclitaxel-eluting stents plus aspirin and clopidogrel for at least 12 months) N=947 CABG (on/off pump surgery with arterial revascularization plus aspirin and clopidogrel for at least 12 months) Primary outcome Death from any cause, nonfatal myocardial infarction, or nonfatal stroke at 5 years https://web.pathway.md/studies/recLVhOw5JqWMqsN5 1/2 6/28/23, 10:40 PM FREEDOM Pathway 26.6 % 26.6 20.0 % 18.7 13.3 % Significant increase 6.7 % NNH = 13 0.0 % Percutaneous coronary artery intervention Coronary artery bypass graft Significant increase in death from any cause, nonfatal myocardial infarction, or nonfatal stroke at 5 years (26.6% vs. 18.7%; AD 7.9%, 95% CI 3.3 to 12.5) Secondary outcomes Significant increase in major adverse cardiovascular and cerebrovascular events at 1 year (16.8% vs. 11.8%; RR 1.42, 95% CI 0.45 to 2.39) No significant difference in death at 1 year (3.4% vs. 4.2%; RR 0.81, 95% CI -0.87 to 2.49) Significant increase in repeat revascularization at 1 year (12.6% vs. 4.8%; RR 2.63, 95% CI 1.07 to 4.19) Safety outcomes No significant difference in major bleeding event within 30 days after index revascularization. Significant difference in acute renal failure requiring hemodialysis within 30 days after index revascularization (0.1% vs. 0.8%). Conclusion In patients with diabetes and multivessel coronary artery disease, percutaneous coronary artery intervention was inferior to CABG with respect to death from any cause, nonfatal myocardial infarction, or nonfatal stroke at 5 years. Reference Farkouh ME, Domanski M, Sleeper LA et al. Strategies for multivessel revascularization in patients with diabetes. N Engl J Med. 2012 Dec 20;367(25):2375-84. Open reference URL https://web.pathway.md/studies/recLVhOw5JqWMqsN5 2/2