Strategies for Multivessel Revascularization in Patients with Diabetes

Author Department

Anesthesiology

Document Type

Article, Non peer-reviewed

Publication Date

2-2013

Abstract

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.

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.

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) and death from any cause (P = 0.049). Stroke was more frequent in the CABG group, with 5-year rates of 2.4% in the PCI group and 5.2% in the CABG group (P = 0.03).

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.)

Comments
This multi-centered, randomized clinical trial set out to determine the superiority of CABG vs. PCI in diabetic patients with multivessel coronary artery disease (without left main disease). There has been a history of trials suggesting a benefit of CABG over PCI in diabetics, however many of these studies have had significant limitations. The BARI trial compared balloon angioplasty to CABG, and demonstrated that diabetics with multivessel disease had improved outcomes with CABG. However, in the era of drug eluting stents, this trial and its results are difficult to extrapolate to current practice. The Coronary Artery Revascularization in Diabetes (CARDia) study was a randomized trial in diabetics with multivessel disease comparing CABG vs. PCI with both bare metal and drug eluting stents, but it was underpowered and lacked long-term follow-up. A subgroup analysis of patients with multivessel disease and diabetes in the Synergy Between Percutaneous Coronary Intervention with TAXUS and Cardiac Surgery (SYNTAX) trial also demonstrated a benefit of CABG over PCI.

The current investigators sought to compare CABG with the current practice of PCI with drug eluting stents in diabetics with multivessel CAD. A total of 1900 patients at 140 centers were recruited and had a minimum of 2 years of follow-up. Patients were then monitored while attempts were made to optimize their risk of adverse events by controlling blood pressure, LDL cholesterol, and glycated hemoglobin. The primary endpoint was a composite of death from any cause, nonfatal myocardial infarction, or nonfatal stroke. They demonstrated a decreased risk of nonfatal MI and death from any cause with CABG (although the study was underpowered to detect the latter subgroup), while strokes were more common in the CABG group.

Strengths of the study include that it is a randomized, multicenter trial, with similar patient characteristics between the two study groups, and improved follow-up over prior investigations. It focused on a clinically relevant question in a specific group of patients (diabetics with multivessel coronary artery disease and without left main disease). Limitations include the inability to blind the study, and lack of power to perform meaningful sub-group analyses.

This study supports others that have suggested that CABG is the preferred method of revascularization over PCI with drug eluting stents in diabetics with multivessel coronary artery disease without left main disease.

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