FREEDOM
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
71.0% male
N = 1900
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 MI, or nonfatal stroke at 5 years
26.6%
18.7%
26.6 %
20.0 %
13.3 %
6.7 %
0.0 %
Percutaneous coronary artery
intervention
Coronary artery bypass
graft
Significant
increase ▲
NNH = 12
Significant increase in death from any cause, nonfatal MI, 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 MI, 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.
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