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On-pump versus off-pump coronary artery bypass graft surgery among patients with type 2 diabetes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

ABSTRACT: Conclusive evidence is lacking regarding the benefits and risks of performing off-pump versus on-pump coronary artery bypass graft (CABG) for patients with diabetes. This study aims to compare clinical outcomes after off-pump and on-pump procedures for patients with diabetes.The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial enrolled patients with type 2 diabetes and documented coronary artery disease, 615 of whom underwent CABG during the trial. The procedural complications, 30-day outcomes, long-term clinical and functional outcomes were compared between the off-pump and on-pump groups overall and within a subset of patients matched on propensity score.On-pump CABG was performed in 444 (72%) patients, and off-pump CABG in 171 (28%). The unadjusted 30-day rate of death/myocardial infarction (MI)/stroke was significantly higher after off-pump CABG (7.0 vs 2.9%, P = 0.02) despite fewer complications (10.3 vs 20.7%, P = 0.003). The long-term risk of death [adjusted hazard ratio (aHR): 1.41, P = 0.2197] and major cardiovascular events (death, MI or stroke) (aHR: 1.47, P = 0.1061) did not differ statistically between the off-pump and on-pump patients. Within the propensity-matched sample (153 pairs), patients who underwent off-pump CABG had a higher risk of the composite outcome of death, MI or stroke (aHR: 1.83, P = 0.046); the rates of procedural complications and death did not differ significantly, and there were no significant differences in the functional outcomes.Patients with diabetes had greater risk of major cardiovascular events long-term after off-pump CABG than after on-pump CABG.

SUBMITTER: Singh A

PROVIDER: S-EPMC4711702 | biostudies-other | 2016 Feb

REPOSITORIES: biostudies-other

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On-pump versus off-pump coronary artery bypass graft surgery among patients with type 2 diabetes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

Singh Ashima A Schaff Hartzell V HV Mori Brooks Maria M Hlatky Mark A MA Wisniewski Stephen R SR Frye Robert L RL Sako Edward Y EY

European journal of cardio-thoracic surgery : official journal of the European Association for Cardio-thoracic Surgery 20150511 2

<h4>Objectives</h4>Conclusive evidence is lacking regarding the benefits and risks of performing off-pump versus on-pump coronary artery bypass graft (CABG) for patients with diabetes. This study aims to compare clinical outcomes after off-pump and on-pump procedures for patients with diabetes.<h4>Methods</h4>The Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial enrolled patients with type 2 diabetes and documented coronary artery disease, 615 of whom underwent CABG d ...[more]

PMID: 25968885

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Project description:Rosiglitazone improves glycemic control for patients with type 2 diabetes mellitus, but there remains controversy regarding an observed association with cardiovascular hazard. The cardiovascular effects of rosiglitazone for patients with coronary artery disease remain unknown.To examine any association between rosiglitazone use and cardiovascular events among patients with diabetes mellitus and coronary artery disease, we analyzed events among 2368 patients with type 2 diabetes mellitus and coronary artery disease in the Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) trial. Total mortality, composite death, myocardial infarction, and stroke, and the individual incidence of death, myocardial infarction, stroke, congestive heart failure, and fractures, were compared during 4.5 years of follow-up among patients treated with rosiglitazone versus patients not receiving a thiazolidinedione by use of Cox proportional hazards and Kaplan-Meier analyses that included propensity matching. After multivariable adjustment, among patients treated with rosiglitazone, mortality was similar (hazard ratio [HR], 0.83; 95% confidence interval [CI], 0.58-1.18), whereas there was a lower incidence of composite death, myocardial infarction, and stroke (HR, 0.72; 95% CI, 0.55-0.93) and stroke (HR, 0.36; 95% CI, 0.16-0.86) and a higher incidence of fractures (HR, 1.62; 95% CI, 1.05-2.51); the incidence of myocardial infarction (HR, 0.77; 95% CI, 0.54-1.10) and congestive heart failure (HR, 1.22; 95% CI, 0.84-1.82) did not differ significantly. Among propensity-matched patients, rates of major ischemic cardiovascular events and congestive heart failure were not significantly different.Among patients with type 2 diabetes mellitus and coronary artery disease in the BARI 2D trial, neither on-treatment nor propensity-matched analysis supported an association of rosiglitazone treatment with an increase in major ischemic cardiovascular events.URL: http://www.clinicaltrials.gov. Unique identifier: NCT00006305.

Project description:The economic outcomes of clinical management strategies are important in assessing their value to patients.Bypass Angioplasty Revascularization Investigation 2 Diabetes (BARI 2D) randomized patients with type 2 diabetes mellitus and angiographically documented, stable coronary disease to strategies of (1) prompt revascularization versus medical therapy with delayed revascularization as needed to relieve symptoms and (2) insulin sensitization versus insulin provision. Before randomization, the physician declared whether coronary artery bypass grafting or percutaneous coronary intervention would be used if the patient were assigned to revascularization. We followed 2005 patients for medical utilization and costs and assessed the cost-effectiveness of these management strategies. Medical costs were higher for revascularization than medical therapy, with a significant interaction with the intended method of revascularization (P<0.0001). In the coronary artery bypass grafting stratum, 4-year costs were $80 900 for revascularization versus $60 600 for medical therapy (P<0.0001). In the percutaneous coronary intervention stratum, costs were $73 400 for revascularization versus $67 800 for medical therapy (P<0.02). Costs also were higher for insulin sensitization ($71 300) versus insulin provision ($70 200). Other factors that significantly (P<0.05) and independently increased cost included insulin use and dose at baseline, female sex, white race, body mass index > or =30, and albuminuria. Cost-effectiveness based on 4-year data favored the strategy of medical therapy over prompt revascularization and the strategy of insulin provision over insulin sensitization. Lifetime projections of cost-effectiveness showed that medical therapy was cost-effective compared with revascularization in the percutaneous coronary intervention stratum ($600 per life-year added) with high confidence. Lifetime projections suggest that revascularization may be cost-effective in the coronary artery bypass grafting stratum ($47 000 per life-year added) but with lower confidence.Prompt coronary revascularization significantly increases costs among patients with type 2 diabetes mellitus and stable coronary disease. The strategy of medical therapy (with delayed revascularization as needed) appears to be cost-effective compared with the strategy of prompt coronary revascularization among patients identified a priori as suitable for percutaneous coronary intervention.

Dataset Information

On-pump versus off-pump coronary artery bypass graft surgery among patients with type 2 diabetes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

Publications

On-pump versus off-pump coronary artery bypass graft surgery among patients with type 2 diabetes in the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial.

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