The BARI 2D Trial

The BARI 2D Study Group. A randomized trial of therapies for type 2 diabetes and coronary artery disease.

In this study, the authors report the findings of the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial, involving 2368 patients with both diabetes and coronary disease.

Patients with type 2 diabetes and stable ischemic heart disease were randomly assigned to early revascularization plus intensive medical therapy or intensive medical therapy alone. For patients randomized to revascularization, the treating physician decided whether PCI or CABG was more appropriate. The drug treatments were also randomly assigned to either insulin-provision therapy or insulin-sensitization therapy.

Overall, five-year cardiac death rates were similar in the patients getting medical therapy or revascularization (5.7% vs 5.9%). Among the 763 patients with more extensive disease deemed suitable for bypass surgery, MI and death (10%) or MI (21.1%) were much less common after prompt surgery than medical therapy alone (17.6% and 29.2%, respectively). However, all of this benefit was seen in the patients taking insulin-sensitizing drugs.

Comments

BARI 2D underscores how major advances in PCI, CABG, and optimal medical therapy have created a constantly moving target against which the comparative effectiveness of rapidly evolving treatments must be repeatedly assessed. Will the results of BARI 2D change clinical practice? In the United States, the use of PCI, particularly with drug-eluting stents, remains high (1.2 million procedures per year). Yet, as health
care costs continue to spiral upward, physicians, payers, and health economists need to make informed,
evidence-based treatment decisions that improve both symptoms and clinical outcomes. BARI 2D shows that for many patients with both diabetes and coronary disease, optimal medical therapy rather than any intervention is an excellent first-line strategy, particularly for those with less severe disease. When revascularization is indicated, both BARI 2D and other studies support the use of CABG as the preferred approach, unless or until future studies indicate otherwise.

Finally, although the results of any randomized trial must be individualized for specific patients, a “multidisciplinary team approach” to clinical decision making, as originally advocated by Simoons
and used successfully in a recent trial, can ensure that all therapeutic options (optimal
medical therapy, PCI, and CABG) are fully and transparently discussed so that patients are offered the most appropriate, evidence-based treatment recommendations.

References:

1: A Randomized Trial of Therapies for Type 2 Diabetes and Coronary Artery Disease, The BARI 2D Study Group. N Engl J Med 2009; 360:2503-2515

2. Diabetes with Coronary Disease — A Moving Target amid Evolving Therapies? William E. Boden, M.D., and David P. Taggart, M.D., Ph.D., N Engl J Med 2009 360;24,2570-2572