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BARI 2D perspectives: prompt revascularization vs. optimal medical therapy
Results sharpen the debate between PCI, surgery for patients with diabetes.
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TCT 2009
Four experts offered different perspectives on the results of BARI 2D — a trial that examined revascularization in patients with diabetes — at the Transcatheter Cardiovascular Therapeutics Conference yesterday.
The trial included 2,368 patients with type 2 diabetes and stable coronary disease. Each patient was assigned by their referring physician to a medical therapy strategy or to coronary artery bypass graft surgery (n=763) or percutaneous coronary intervention (n=1,605). Patients were then randomly assigned optimal medical therapy or revascularization, and insulin-sensitization vs. insulin-provision therapy to reach an HbA1c goal of <7%.
At five years, there was no difference in mortality — the primary outcome — between patients randomly assigned to revascularization (88.3%) with PCI or CABG compared with medical therapy alone (87.8%; P=.97). Rates of survival were also similar between patients assigned to insulin-sensitization (88.2%) vs. insulin-provision therapy (87.9%; P=.89). Prompt revascularization also had no benefit on freedom from major CV events (composite of death, myocardial infarction and stroke) vs. intensive therapy (77.2% vs. 75.9%; P=.70).
When examined separately, however, although PCI vs. medical therapy showed no difference in rate of death or CV events, prompt CABG, when compared with medical therapy alone, yielded significantly better outcomes when major CV events were considered in addition to death (22.4% vs. 30.5%; P=.01). Much of the benefit with CABG was an observed reduction in nonfatal MI (7.4% vs. 14.6%).
Medical therapy alone vs. surgery
Evidence supports optimal medical therapy as an initial approach for patients with diabetes and stable CAD, according to William E. Boden, MD, lead investigator of the COURAGE trial.
“We have 13 randomized trials in more than 7,600 patients, including BARI 2D, that show no difference in death, MI, stroke, hospitalization for acute coronary syndrome, or other hard endpoints between PCI and optimal medical therapy,” said Boden, professor of medicine and preventive medicine at University of Buffalo Schools of Public Medicine and Public Health.
Initially, optimal medical therapy first “preserves the option for PCI if intensive medical therapy fails,” he said. Seven-year follow-up data from COURAGE indicated that 67% of patients assigned to medical therapy alone never required a first PCI, and five-year BARI 2D data showed that 58% also avoided a procedure.
David P. Taggart, MD, said CABG may be the better choice for this patient population, because “BARI 2D researchers reported no benefit of PCI vs. optimal medical therapy, and CABG reduced the risk for MI and also reduced absolute mortality by 3%.”
A caution: “Most randomized controlled trials only include patients with diabetes with low-severity CAD, with the exception of the SYNTAX trial,” said Taggart, professor of cardiovascular surgery at University of Oxford.
Patients in BARI 2D assigned to CABG had more severe disease at baseline, including 52% with three-vessel disease vs. 20% of PCI patients, and 19% with significant left anterior descending disease vs. 10% of PCI patients.
Kevin J. Beatt, MD, from Mayday University Hospital, United Kingdom, said that the question being asked since the publication of BARI 2D is “should we still perform PCI in patients with diabetes and multivessel disease?”
Patients with diabetes “have a wide range of preprocedural risk that is poorly documented and not adequately covered by any of the current risk scores, such as SYNTAX and Euro-Heart,” according to Beatt. Insulin therapy is associated with especially high risk, and he said including these patients in major trials is “inappropriate.”
Appropriate revascularization is key
Symptoms, degree and presence of ischemia and high-risk anatomy should guide revascularization in patients with diabetes and stable CAD, Jeffrey W. Moses, MD, said in a related session.
“BARI 2D verifies the concept that there is a sizeable group of stable, mildly symptomatic patients with type 2 diabetes without traditional critical three-vessel disease who benefit from prophylactic revascularization,” said Moses, from Columbia University Medical Center, New York.
Yet, “our limited understanding of the ischemic burden in this overall low-risk cohort is problematic in guiding appropriate triage. Clearly, most patients with diabetes do very well with intensive medical therapy directed to secondary prevention, as do most patients with manifest CAD.”
Appropriate revascularization is key, he said. “PCI is preferred in most PCI-eligible patients with multivessel disease as long-term data with stents demonstrate similar rates of death and MI compared with CABG,” he said. Patients with diffuse multivessel disease and/or insulin requirement may be best suited for CABG, he added.
The BARI 2D trial results were presented in June at the American Diabetes Association’s 69th Scientific Sessions and were published simultaneously in The New England Journal of Medicine. – by Katie Kalvaitis