BARI 2D：一项关注心血管事件的再分析。
BARI 2D: A Reanalysis Focusing on Cardiovascular Events.
机构信息
Division of Clinical and Molecular Endocrinology, Department of Medicine, Case Western Reserve University, Cleveland, OH.
Epidemiology Data Center, University of Pittsburgh, PA.
出版信息
Mayo Clin Proc. 2019 Nov;94(11):2249-2262. doi: 10.1016/j.mayocp.2019.04.015. Epub 2019 Oct 4.
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 A 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.
目的
使用新的复合心血管疾病（CVD）结局重新分析经皮腔内冠状动脉血管成形术血运重建糖尿病 2 型试验，以确定如何最好地治疗 2 型糖尿病和稳定型冠状动脉疾病患者。
患者和方法
从 2001 年 1 月 1 日至 2008 年 11 月 30 日，2368 例 2 型糖尿病和经血管造影证实的冠状动脉疾病患者被随机分配到胰岛素增敏（IS）或胰岛素提供（IP）治疗，并同时进行冠状动脉血运重建（REV）或无血运重建或延迟血运重建（强化药物治疗[MED]），所有患者均接受强化药物治疗。该分析的结果是 8 个 CVD 事件的复合。
结果
IS 治疗组和 IP 治疗组的 4 年 Kaplan-Meier 复合 CVD 结局发生率分别为 35.8%（95%CI，33.1%-38.5%）和 41.6%（95%CI，38.7%-44.5%）（P=.004）。这种差异主要与 IS 治疗组的试验期间纤维蛋白原、C 反应蛋白和血红蛋白 A 水平较低有关。REV 组的 4 年复合 CVD 发生率为 32.7%（95%CI，30.0%-35.4%），MED 组为 44.7%（95%CI，41.8%-47.6%）（P<.001）。REV 时 IS 治疗优于 IP 治疗（27.7%；95%CI，24.0%-31.4%vs 37.5%；95%CI，33.6%-41.4%；P<.001），但 MED 时并非如此（43.6%；95%CI，39.5%-47.7%vs 45.7%；95%CI，41.6%-49.8%；P=.37）（同质性，P=.05）。IS 治疗与 REV 之间的这种相互作用仅限于预先选择冠状动脉旁路移植术（CABG）的参与者。预先选择 CABG 并接受 IS 治疗和 REV 治疗的患者发生复合 CVD 事件的风险最低（17.3%；95%CI，11.8%-22.8%）。
结论
在经皮腔内冠状动脉血管成形术血运重建糖尿病 2 型试验中，IS 治疗策略和 REV 治疗策略均可降低心血管事件。IS 药物联合 CABG 可使随后发生 CVD 事件的风险最低。
试验注册
clinicaltrials.gov 标识符：NCT00006305。
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