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Revascularization no better than medical therapy for stable IHD in Type 2 diabetics
8 June 2009
MedWire News:
Similarly, the researchers found no significant differences between mortality and CV event rate between those treated with insulin provision versus insulin sensitization strategies.
“Few large, randomized trials have addressed the question of the optimal treatment for patients with diabetes and angiographically defined stable ischemic heart disease,” comment Maria Brooks (University of Pittsburgh, Philadelphia, USA) and co-researchers in the New England Journal of Medicine.
The BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial enrolled 2368 patients with Type 2 diabetes and IHD between January 2001 and March 2005. Patients were followed up for an average period of 5 years.
Participants were sorted into two revascularization groups by their individual suitability for percutaneous coronary intervention (PCI, n=1605) versus coronary artery bypass graft (CABG, n=763).
The CABG group were then randomly assigned to receive CABG (n=378) or intensive medical therapy including statins, aspirin, and beta-blockers (n=385), and the PCI group to receive PCI (n=798) or intensive medical therapy (n=807). A further round of randomization was then carried out to assign participants to either insulin provision (n=1185) or insulin sensitization (n=1183) therapy.
At 5 years, rates of survival were 88.3% in the revascularization group and 87.8% in the intensive medical therapy group, a non-significant difference.
Survival was also non-significantly different between patients taking insulin provision or insulin sensitization therapy at 87.9% and 88.2%, respectively.
Rates of freedom from CV events (CV death, myocardial infarction, or stroke) were also similar at 77.2%, 75.9%, 77.7%, and 75.4% in the revascularization, intensive medical therapy, insulin sensitization, and insulin provision groups, respectively.
When the researchers assessed the results by type of revascularization, they found no significant difference in outcomes between patients who had PCI versus intensive medical therapy. However, they found that significantly less patients who underwent CABG had major CV events compared with those on intensive medical therapy at 22.4% versus 30.5%, largely driven by a greater reduction in nonfatal myocardial infarction.
Brooks et al note that adverse events were generally similar across the different groups, but that severe hypoglycemia was more common in the insulin provision group compared with the insulin sensitization group at 9.2% versus 5.9%. Insulin sensitization therapy also seemed to provide more significant improvements in plasma insulin, glycated hemoglobin, high-density lipoprotein cholesterol, and weight gain than insulin provision therapy.
“Overall, the BARI 2D results reassure us that our current major drug treatments for diabetes are equally appropriate,” said study author Saul Genuth (Case Western Reserve University, Cleveland, Ohio, USA).
“They also indicate that when a patient with Type 2 diabetes has more severe heart disease it may be better to do bypass surgery early than to wait and simply treat with medication. For patients with milder disease who are candidates for angioplasty, it is appropriate to treat with drug therapy first.”
The results from the BARI 2D trial were presented at the American Diabetes Association 69th Scientific Sessions held in New Orleans, Louisiana.
