糖尿病患者においてCABGは薬剤溶出ステントよりも
優れている（LBCT-19997）

FREEDOM：糖尿病患者の冠動脈多枝病変に対しては薬剤溶出ステントよりもバイパス術の方が有意に優れている
FREEDOM: Bypass surgery significantly better than drug-eluting stents for treating multivessel coronary artery disease in diabetics
冠動脈多枝病変（MV-CAD）を有する糖尿病患者は薬剤溶出ステントよりも冠動脈バイパス術（CABG）を施行された方が有意に予後が良好であったとのLate-Breaking Clinical Trialの結果が2012年American Heart Association学会で発表され、同時にNew England Journal of Medicineに掲載された。Future REvascularization Evaluation in patients with Diabetes mellitus：Optimal management of Multivessel disease（FREEDOM）トライアルではMV-CADを有する糖尿病患者1,900人を薬剤溶出ステントを用いた経皮的冠動脈インターベンション（PCI）またはCABG群に無作為に割り付けた。患者の平均年齢は63.1±9.1歳であり、29%が女性で糖尿病罹病期間中央値は10.2±8.9年であった。5年以内に心筋梗塞（MI）または脳卒中を発現した者または死亡した者はバイパス手術群で18.7%であったのに対し、薬剤溶出ステントによるPCIを施行された患者群では26.6%であった（P =0.005）。CABG群のうちMIを発症したのは6%であったのに対し、PCI群では13.9%であった（P <0.001）。しかし、脳卒中はCABG群において多く認められた―5.2%対2.4%。多枝病変を有する糖尿病患者に対する血行再建術としてはCABG手術が好ましい方法である、と筆者らは結論付けている。
Full Text

Patients with diabetes who have multivessel coronary artery (MV-CAD) disease fare significantly better if they undergo coronary artery bypass graft (CABG) surgery instead of being treated with drug eluting stents according to late-breaking trial results presented at the American Heart Association's Scientific Sessions 2012.

The full manuscript for the Future REvascularization Evaluation in patients with Diabetes mellitus: Optimal management of Multivessel disease (FREEDOM) Trial is published in the New England Journal of Medicine.

In the study, researchers randomly assigned 1900 diabetic patients at 140 centers globally to receive either percutaneous coronary intervention (PCI) with drug-eluting stents or CABG. Patients were 63.1±9.1 years old and 29% female with median diabetes duration of 10.2±8.9 years. All study patients were prescribed medications to control their blood pressure, cholesterol and blood sugar based on current treatment guidelines.

At five years, 18.7% percent of those who underwent bypass surgery suffered a myocardial infarction (MI) or stroke or died within five years, as compared to 26.6% of those who received a drug eluting stent (P=0.005). Six percent of patients in the CABG group had an MI as compared to 13.9% of the PCI group (P<0.001).

"These results were very striking," said Valentin Fuster, M.D., the study's lead researcher and director of Mount Sinai Heart at the Mount Sinai Medical Center in New York. "In a majority of places in the world, these patients were receiving stents. This is going to change practice."

Researchers followed patients' progress from 2005- 2010. Those undergoing bypass surgery had fewer deaths and heart attacks. However, they had more strokes — 5.2 percent versus 2.4 percent — not enough to negate the net significant benefits of fewer deaths and heart attacks, Fuster said.

Earlier studies in this group of patients showed that bypass was favorable compared to angioplasty. However, many of those studies did not use drug-eluting stents.

"But the cardiology community didn't know if that held true when compared exclusively to newer, drug-covered stents," said Fuster. "So we are so excited to find the answer."

In the trial, 29 percent of the patients were female, the average age was about 63 years and the average time since receiving the diagnosis of diabetes was about 10 years. The majority, 83 percent, had coronary disease in three arteries.

"We always want to know how long the effects last." Fuster said. "The gap could begin to close or the results could get better and better. So, longer follow-up is critical."

His team is seeking additional funding to continue follow-up of these patients.
Co-author is Michael E. Farkouh, M.D.

The National Institutes of Health funded the study.