BARI 2D: A Reanalysis Focusing on Cardiovascular Events

BARI 2D Study Group

Research output: Contribution to journalArticle

Abstract

Objective: To reanalyze the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial using a new composite cardiovascular disease (CVD) outcome to determine how best to treat patients with type 2 diabetes mellitus and stable coronary artery disease. Patients and Methods: From January 1, 2001, to November 30, 2008, 2368 patients with type 2 diabetes mellitus and angiographically proven coronary artery disease were randomly assigned to insulin-sensitizing (IS) or insulin-providing (IP) therapy and simultaneously to coronary revascularization (REV) or no or delayed REV (intensive medical therapy [MED]), with all patients receiving intensive medical treatment. The outcome of this analysis was a composite of 8 CVD events. Results: Four-year Kaplan-Meier rates for the composite CVD outcome were 35.8% (95% CI, 33.1%-38.5%) with IS therapy and 41.6% (95% CI, 38.7%-44.5%) with IP therapy (P=.004). Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A1c with IS therapy. Four-year composite CVD rates were 32.7% (95% CI, 30.0%-35.4%) with REV and 44.7% (95% CI, 41.8%-47.6%) with MED (P<.001). A beneficial effect of IS vs IP therapy was present with REV (27.7%; 95% CI, 24.0%-31.4% vs 37.5%; 95% CI, 33.6%-41.4%; P<.001), but not with MED (43.6%; 95% CI, 39.5%-47.7% vs 45.7%; 95% CI, 41.6%-49.8%; P=.37) (homogeneity, P=.05). This interaction between IS therapy and REV was limited to participants preselected for coronary artery bypass grafting (CABG). The lowest composite CVD rates occurred in patients preselected for CABG and assigned to IS therapy and REV (17.3%; 95% CI, 11.8%-22.8%). Conclusion: In the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial, the IS treatment strategy and the REV treatment strategy each reduces cardiovascular events. The combination of IS drugs and CABG results in the lowest risk of subsequent CVD events. Trial Registration: clinicaltrials.gov Identifier: NCT00006305

Original languageEnglish (US)
Pages (from-to)2249-2262
Number of pages14
JournalMayo Clinic Proceedings
Volume94
Issue number11
DOIs
StatePublished - Nov 2019

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Insulin
Cardiovascular Diseases
Therapeutics
Coronary Artery Bypass
Angioplasty
Type 2 Diabetes Mellitus
Coronary Artery Disease
C-Reactive Protein
Fibrinogen
Hemoglobins
Pharmaceutical Preparations

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BARI 2D : A Reanalysis Focusing on Cardiovascular Events. / BARI 2D Study Group.

In: Mayo Clinic Proceedings, Vol. 94, No. 11, 11.2019, p. 2249-2262.

Research output: Contribution to journalArticle

BARI 2D Study Group. / BARI 2D : A Reanalysis Focusing on Cardiovascular Events. In: Mayo Clinic Proceedings. 2019 ; Vol. 94, No. 11. pp. 2249-2262.
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title = "BARI 2D: A Reanalysis Focusing on Cardiovascular Events",
abstract = "Objective: To reanalyze the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial using a new composite cardiovascular disease (CVD) outcome to determine how best to treat patients with type 2 diabetes mellitus and stable coronary artery disease. Patients and Methods: From January 1, 2001, to November 30, 2008, 2368 patients with type 2 diabetes mellitus and angiographically proven coronary artery disease were randomly assigned to insulin-sensitizing (IS) or insulin-providing (IP) therapy and simultaneously to coronary revascularization (REV) or no or delayed REV (intensive medical therapy [MED]), with all patients receiving intensive medical treatment. The outcome of this analysis was a composite of 8 CVD events. Results: Four-year Kaplan-Meier rates for the composite CVD outcome were 35.8{\%} (95{\%} CI, 33.1{\%}-38.5{\%}) with IS therapy and 41.6{\%} (95{\%} CI, 38.7{\%}-44.5{\%}) with IP therapy (P=.004). Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A1c with IS therapy. Four-year composite CVD rates were 32.7{\%} (95{\%} CI, 30.0{\%}-35.4{\%}) with REV and 44.7{\%} (95{\%} CI, 41.8{\%}-47.6{\%}) with MED (P<.001). A beneficial effect of IS vs IP therapy was present with REV (27.7{\%}; 95{\%} CI, 24.0{\%}-31.4{\%} vs 37.5{\%}; 95{\%} CI, 33.6{\%}-41.4{\%}; P<.001), but not with MED (43.6{\%}; 95{\%} CI, 39.5{\%}-47.7{\%} vs 45.7{\%}; 95{\%} CI, 41.6{\%}-49.8{\%}; P=.37) (homogeneity, P=.05). This interaction between IS therapy and REV was limited to participants preselected for coronary artery bypass grafting (CABG). The lowest composite CVD rates occurred in patients preselected for CABG and assigned to IS therapy and REV (17.3{\%}; 95{\%} CI, 11.8{\%}-22.8{\%}). Conclusion: In the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial, the IS treatment strategy and the REV treatment strategy each reduces cardiovascular events. The combination of IS drugs and CABG results in the lowest risk of subsequent CVD events. Trial Registration: clinicaltrials.gov Identifier: NCT00006305",
author = "{BARI 2D Study Group} and Genuth, {Saul M.} and Helen Vlachos and Brooks, {Maria Mori} and Bantle, {John P.} and Chaitman, {Bernard R.} and Jennifer Green and Kelsey, {Sheryl F.} and King, {Spencer B.} and Robert McBane and Sako, {Edward Y.} and Schneider, {David J.} and Michael Steffes and Frye, {Robert L.}",
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T1 - BARI 2D

T2 - A Reanalysis Focusing on Cardiovascular Events

AU - BARI 2D Study Group

AU - Genuth, Saul M.

AU - Vlachos, Helen

AU - Brooks, Maria Mori

AU - Bantle, John P.

AU - Chaitman, Bernard R.

AU - Green, Jennifer

AU - Kelsey, Sheryl F.

AU - King, Spencer B.

AU - McBane, Robert

AU - Sako, Edward Y.

AU - Schneider, David J.

AU - Steffes, Michael

AU - Frye, Robert L.

PY - 2019/11

Y1 - 2019/11

N2 - Objective: To reanalyze the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial using a new composite cardiovascular disease (CVD) outcome to determine how best to treat patients with type 2 diabetes mellitus and stable coronary artery disease. Patients and Methods: From January 1, 2001, to November 30, 2008, 2368 patients with type 2 diabetes mellitus and angiographically proven coronary artery disease were randomly assigned to insulin-sensitizing (IS) or insulin-providing (IP) therapy and simultaneously to coronary revascularization (REV) or no or delayed REV (intensive medical therapy [MED]), with all patients receiving intensive medical treatment. The outcome of this analysis was a composite of 8 CVD events. Results: Four-year Kaplan-Meier rates for the composite CVD outcome were 35.8% (95% CI, 33.1%-38.5%) with IS therapy and 41.6% (95% CI, 38.7%-44.5%) with IP therapy (P=.004). Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A1c with IS therapy. Four-year composite CVD rates were 32.7% (95% CI, 30.0%-35.4%) with REV and 44.7% (95% CI, 41.8%-47.6%) with MED (P<.001). A beneficial effect of IS vs IP therapy was present with REV (27.7%; 95% CI, 24.0%-31.4% vs 37.5%; 95% CI, 33.6%-41.4%; P<.001), but not with MED (43.6%; 95% CI, 39.5%-47.7% vs 45.7%; 95% CI, 41.6%-49.8%; P=.37) (homogeneity, P=.05). This interaction between IS therapy and REV was limited to participants preselected for coronary artery bypass grafting (CABG). The lowest composite CVD rates occurred in patients preselected for CABG and assigned to IS therapy and REV (17.3%; 95% CI, 11.8%-22.8%). Conclusion: In the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial, the IS treatment strategy and the REV treatment strategy each reduces cardiovascular events. The combination of IS drugs and CABG results in the lowest risk of subsequent CVD events. Trial Registration: clinicaltrials.gov Identifier: NCT00006305

AB - Objective: To reanalyze the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial using a new composite cardiovascular disease (CVD) outcome to determine how best to treat patients with type 2 diabetes mellitus and stable coronary artery disease. Patients and Methods: From January 1, 2001, to November 30, 2008, 2368 patients with type 2 diabetes mellitus and angiographically proven coronary artery disease were randomly assigned to insulin-sensitizing (IS) or insulin-providing (IP) therapy and simultaneously to coronary revascularization (REV) or no or delayed REV (intensive medical therapy [MED]), with all patients receiving intensive medical treatment. The outcome of this analysis was a composite of 8 CVD events. Results: Four-year Kaplan-Meier rates for the composite CVD outcome were 35.8% (95% CI, 33.1%-38.5%) with IS therapy and 41.6% (95% CI, 38.7%-44.5%) with IP therapy (P=.004). Much of this difference was associated with lower in-trial levels of fibrinogen, C-reactive protein, and hemoglobin A1c with IS therapy. Four-year composite CVD rates were 32.7% (95% CI, 30.0%-35.4%) with REV and 44.7% (95% CI, 41.8%-47.6%) with MED (P<.001). A beneficial effect of IS vs IP therapy was present with REV (27.7%; 95% CI, 24.0%-31.4% vs 37.5%; 95% CI, 33.6%-41.4%; P<.001), but not with MED (43.6%; 95% CI, 39.5%-47.7% vs 45.7%; 95% CI, 41.6%-49.8%; P=.37) (homogeneity, P=.05). This interaction between IS therapy and REV was limited to participants preselected for coronary artery bypass grafting (CABG). The lowest composite CVD rates occurred in patients preselected for CABG and assigned to IS therapy and REV (17.3%; 95% CI, 11.8%-22.8%). Conclusion: In the Bypass Angioplasty Revascularization Investigation 2 Diabetes trial, the IS treatment strategy and the REV treatment strategy each reduces cardiovascular events. The combination of IS drugs and CABG results in the lowest risk of subsequent CVD events. Trial Registration: clinicaltrials.gov Identifier: NCT00006305

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