评估 2 型糖尿病患者的动脉粥样硬化血栓形成风险。
Assessment of Atherothrombotic Risk in Patients With Type 2 Diabetes Mellitus.
机构信息
TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
TIMI Study Group, Division of Cardiovascular Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, Massachusetts, USA.
出版信息
J Am Coll Cardiol. 2023 Jun 27;81(25):2391-2402. doi: 10.1016/j.jacc.2023.04.031.
BACKGROUND
Risk of atherothrombotic events is not uniform in patients with type 2 diabetes mellitus (T2DM). Tailored risk assessment may help guide selection of pharmacotherapies for cardiovascular primary and secondary prevention.
OBJECTIVES
The purpose of this study was to develop a risk model for atherothrombosis in patients with T2DM.
METHODS
We developed and validated a risk model for myocardial infarction (MI) or ischemic stroke (IS) in a pooled cohort of 42,181 patients with T2DM from 4 TIMI (Thrombolysis In Myocardial Infarction) clinical trial cohorts. Candidate variables were assessed with multivariable Cox regression, and independent variables (P < 0.05) were retained in the final model. Discrimination and calibration were assessed. Treatment interactions with dapagliflozin (sodium-glucose cotransporter-2 inhibitor) and evolocumab (proprotein convertase subtilisin/kexin type 9 inhibitor) were explored in the DECLARE-TIMI 58 (Dapagliflozin Effect on CardiovascuLAR Events-Thrombolysis In Myocardial Infarction 58) and FOURIER (Further Cardiovascular Outcomes Research with PCSK9 Inhibition in Subjects with Elevated Risk) trials, respectively.
RESULTS
Sixteen variables were independent predictors of MI or IS. The model identified a >8-fold gradient of MI or IS rates between the top vs bottom risk quintiles in the validation cohort (3-year Kaplan-Meier rate: 14.9% vs 1.4%; P < 0.0001). C-indexes were 0.704 and 0.706 in the derivation and validation cohorts, respectively. The model was well-calibrated in both primary and secondary prevention. Absolute reduction in the rates of MI or IS tended to be greater in patients with higher baseline predicted risk for both dapagliflozin (absolute risk reduction: 2.1% vs 0.2%) and evolocumab (absolute risk reduction: 3.2% vs 1.0%).
CONCLUSIONS
We developed and validated a risk score for atherothrombotic events, leveraging 16 routinely assessed clinical variables in patients with T2DM. The score has the potential to improve risk assessment and inform clinical decision-making.
背景
2 型糖尿病（T2DM）患者的动脉粥样血栓形成风险并不均匀。量身定制的风险评估可能有助于指导心血管一级和二级预防中药物治疗的选择。
目的
本研究旨在为 T2DM 患者建立动脉粥样血栓形成风险模型。
方法
我们从 4 项 TIMI（血栓溶解治疗心肌梗死）临床试验队列的 42181 例 T2DM 患者的汇总队列中开发和验证了心肌梗死（MI）或缺血性卒中（IS）风险模型。采用多变量 Cox 回归评估候选变量，保留最终模型中的独立变量（P<0.05）。评估了区分度和校准度。在 DECLARE-TIMI 58（达格列净对心血管事件的影响-心肌梗死 58 溶栓治疗）和 FOURIER（高风险人群中用 PCSK9 抑制剂进一步进行心血管结局研究）试验中分别探索了达格列净和依洛尤单抗的治疗相互作用。
结果
16 个变量是 MI 或 IS 的独立预测因子。该模型在验证队列中确定了风险最高五分位与最低五分位之间的 MI 或 IS 发生率的>8 倍梯度（3 年 Kaplan-Meier 率：14.9% vs 1.4%；P<0.0001）。在推导和验证队列中，C 指数分别为 0.704 和 0.706。该模型在一级和二级预防中均具有良好的校准度。达格列净（绝对风险降低：2.1%比 0.2%）和依洛尤单抗（绝对风险降低：3.2%比 1.0%）的基线预测风险较高的患者中，MI 或 IS 发生率的绝对降低趋势更大。
结论
我们开发并验证了一种用于动脉粥样血栓形成事件的风险评分，该评分利用了 16 种在 T2DM 患者中常规评估的临床变量。该评分有可能改善风险评估并为临床决策提供信息。
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