1. In patients with diabetes and multivessel disease, coronary artery bypass grafting (CABG) was shown to be superior to percutaneous coronary intervention (PCI) with drug-eluting stents in reducing the risk of all-cause mortality and nonfatal myocardial infarction.
2. Patients treated with PCI experienced a smaller risk of nonfatal stroke, but also had significantly higher rates of revascularization within a year of their procedure compared to those treated with CABG.
Original Date of Publication: December 2012
Study Rundown: Patients with multivessel coronary artery disease regularly undergo revascularization, and a large portion of these patients have diabetes. Prior studies have demonstrated that diabetic patients have greater survival when they receive CABG rather than balloon angioplasty, and as a result, guidelines at the time favored CABG for revascularization. There have been significant advances in PCI over the past few decades, particularly with the advent of drug-eluting stents. As a result, it remains unclear whether CABG or PCI was more suitable for multivessel disease in the context of diabetes.
The Future Revascularization Evaluation in Patients with Diabetes Mellitus: Optimal Management of Multivessel Disease (FREEDOM) trial sought to address this question. Patients with diabetes and multivessel disease were randomized to undergo PCI with drug-eluting stents or CABG in addition to standard medical therapy, and subsequently followed for minimum of 2 years. In summary, CABG was found to be superior to PCI in reducing all-cause mortality and nonfatal myocardial infarctions in this patient population. Compared to PCI, CABG was linked with a small but significant increase in the risk of nonfatal stroke. Nevertheless, this trial supports the use of CABG over PCI in diabetic patients with multivessel disease.
In-Depth [randomized controlled trial]: This randomized controlled trial was conducted at 140 centers around the world. To be included, patients had to have diabetes and angiographically confirmed multivessel disease with stenosis >70% in two or more major coronary arteries in at least two major coronary-artery territories. Patients with left main coronary stenosis were excluded. A total of 1900 patients met these criteria and underwent randomization to either PCI with drug-eluting stents or CABG, where arterial revascularization was encouraged. All patients were treated to optimize their medical risk factors (e.g., low-density lipoprotein levels, blood pressure, glycated hemoglobin), and the primary outcome was a composite of all-cause mortality, nonfatal myocardial infarction, and nonfatal stroke.
The rate of the primary outcome was significantly higher in patients receiving PCI than in those receiving CABG at 5 years (26.6% vs. 18.7%, absolute difference 7.9%, 95%CI 3.3 to 12.5%, p = 0.005). This was driven by lower rates of all-cause mortality (absolute difference 5.4%, 95%CI 1.5 to 9.2%, p = 0.049) and nonfatal myocardial infarction (p < 0.001). Patients treated with PCI experienced significantly fewer strokes than those treated with CABG (p = 0.03). Significantly higher rates of repeat revascularization within 1 year were observed in the PCI compared to CABG group (12.6% vs. 4.8%, p < 0.001).
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