Strategies for Multivessel Revascularization in Patients with Diabetes

Michael E. Farkouh, M.D., Michael Domanski, M.D., Lynn A. Sleeper, Sc.D., Flora S. Siami, M.P.H., George Dangas, M.D., Ph.D., Michael Mack, M.D., May Yang, M.P.H., David J. Cohen, M.D., Yves Rosenberg, M.D., M.P.H., Scott D. Solomon, M.D., Akshay S. Desai, M.D., M.P.H., Bernard J. Gersh, M.B., Ch.B., D.Phil., Elizabeth A. Magnuson, Sc.D., Alexandra Lansky, M.D., Robin Boineau, M.D., Jesse Weinberger, M.D., Krishnan Ramanathan, M.B., Ch.B., J. Eduardo Sousa, M.D., Ph.D., Jamie Rankin, M.D., Balram Bhargava, M.D., John Buse, M.D., Whady Hueb, M.D., Ph.D., Craig R. Smith, M.D., Victoria Muratov, M.D., M.P.H., Sameer Bansilal, M.D., Spencer King, III, M.D., Michel Bertrand, M.D., and Valentin Fuster, M.D., Ph.D. for the FREEDOM Trial Investigators

November 4, 2012DOI: 10.1056/NEJMoa1211585

Abstract
Article
References
Comments: Background
In some randomized trials comparing revascularization strategies for patients with diabetes, coronary-artery bypass grafting (CABG) has had a better outcome than percutaneous coronary intervention (PCI). We sought to discover whether aggressive medical therapy and the use of drug-eluting stents could alter the revascularization approach for patients with diabetes and multivessel coronary artery disease.
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Methods
In this randomized trial, we assigned patients with diabetes and multivessel coronary artery disease to undergo either PCI with drug-eluting stents or CABG. The patients were followed for a minimum of 2 years (median among survivors, 3.8 years). All patients were prescribed currently recommended medical therapies for the control of low-density lipoprotein cholesterol, systolic blood pressure, and glycated hemoglobin. The primary outcome measure was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke.
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Results
From 2005 through 2010, we enrolled 1900 patients at 140 international centers. The patients' mean age was 63.1±9.1 years, 29% were women, and 83% had three-vessel disease. The primary outcome occurred more frequently in the PCI group (P=0.005), with 5-year rates of 26.6% in the PCI group and 18.7% in the CABG group. The benefit of CABG was driven by differences in rates of both myocardial infarction (P<0 .001=".001" 2.4="2.4" 5-year="5-year" 5.2="5.2" and="and" any="any" cabg="cabg" cause="cause" death="death" frequent="frequent" from="from" group="group" in="in" more="more" of="of" pci="pci" rates="rates" stroke="stroke" the="the" was="was" with="with">
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Conclusions
For patients with diabetes and advanced coronary artery disease, CABG was superior to PCI in that it significantly reduced rates of death and myocardial infarction, with a higher rate of stroke. (Funded by the National Heart, Lung, and Blood Institute and others; FREEDOM ClinicalTrials.gov number, NCT00086450.)
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Figure 1Kaplan–Meier Estimates of the Composite Primary Outcome and Death.
Figure 2Primary Composite Outcome, According to Subgroup.