他汀类药物和依折麦布联合治疗治疗中风的目标试验的疗效。
Yield of Dual Therapy With Statin and Ezetimibe in the Treat Stroke to Target Trial.
机构信息
APHP, Department of Neurology and Stroke center, Bichat Hospital, INSERM LVTS-U1148, DHU FIRE, University of Paris, France (P.A., H.C., P.C.L., E.M.).
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada (P.A.).
出版信息
Stroke. 2022 Nov;53(11):3260-3267. doi: 10.1161/STROKEAHA.122.039728. Epub 2022 Sep 26.
BACKGROUND
In atherosclerotic stroke, lipid-lowering treatment with a target LDL (low-density lipoprotein) cholesterol of <70 compared with 100±10 mg/dL reduced the risk of subsequent cardiovascular events. This post hoc analysis explored the relative effects of the combination of statin and ezetimibe (dual therapy) and statin monotherapy in achieving the lower LDL cholesterol target and in reducing the risk of major vascular events, as compared with the higher target group.
METHODS
Patients with ischemic stroke in the previous 3 months or transient ischemic attack within the previous 15 days and evidence of cerebrovascular or coronary artery atherosclerosis were randomly assigned to a target LDL cholesterol of <70 or 100±10 mg/dL, using statin and/or ezetimibe as needed. The primary outcome was the composite of ischemic stroke, myocardial infarction, new symptoms requiring urgent coronary or carotid revascularization, and vascular death. Cox regression model including lipid-lowering therapy as a time varying variable, after adjustment for randomization strategy, age, sex, index event (stroke or transient ischemic attack), and time since the index event.
RESULTS
Among 2860 patients enrolled, patients who were on dual therapy during the trial in the lower target group had a higher baseline LDL cholesterol as compared to patients on statin monotherapy (141±38 versus 131±36, respectively, <0.001). In patients on dual therapy and on statin monotherapy, the achieved LDL cholesterol was 66.2 and 64.1 mg/dL respectively, and the primary outcome was reduced during dual therapy as compared with the higher target group (HR, 0.60 [95% CI, 0.39-0.91]; =0.016) but not during statin monotherapy (HR, 0.92 [95% CI, 0.70-1.20]; =0.52), with no significant increase in intracranial bleeding.
CONCLUSIONS
In the TST trial (Treat Stroke to Target), targeting an LDL cholesterol of < 70 mg/dL with a combination of statin and ezetimibe compared with 100±10 mg/dL consistently reduced the risk of subsequent stroke.
REGISTRATION
URL: https://www.
CLINICALTRIALS
gov; Unique identifier: NCT01252875. URL: clinicaltrialsregister.eu; Unique identifier: EUDRACT2009-A01280-57.
背景
在动脉粥样硬化性卒中患者中，与目标 LDL（低密度脂蛋白）胆固醇值为 100±10mg/dL 相比，将 LDL 胆固醇值降至<70mg/dL 的降脂治疗可降低随后发生心血管事件的风险。本事后分析旨在探讨他汀类药物联合依折麦布（双联治疗）和他汀类药物单药治疗在实现更低 LDL 胆固醇目标和降低主要血管事件风险方面的相对效果，与较高的目标组相比。
方法
在过去 3 个月内发生过缺血性卒中或在过去 15 天内发生过短暂性脑缺血发作且存在脑血管或冠状动脉粥样硬化证据的患者，随机分配至 LDL 胆固醇目标值<70mg/dL 或 100±10mg/dL 组，需要时使用他汀类药物和/或依折麦布进行治疗。主要复合终点为缺血性卒中、心肌梗死、需要紧急冠状动脉或颈动脉血运重建的新症状和血管性死亡。采用 Cox 回归模型，将降脂治疗作为时变变量，调整随机分组策略、年龄、性别、指数事件（卒中或短暂性脑缺血发作）和指数事件发生后的时间。
结果
在 2860 例入组患者中，与他汀类药物单药治疗组相比，接受双联治疗的患者在较低目标组中的基线 LDL 胆固醇水平更高（分别为 141±38 与 131±36，P<0.001）。在接受双联治疗和他汀类药物单药治疗的患者中，分别达到 LDL 胆固醇水平为 66.2mg/dL 和 64.1mg/dL，与较高目标组相比，双联治疗降低了主要终点事件的发生风险（HR，0.60[95%CI，0.39-0.91]；P=0.016），而他汀类药物单药治疗未降低（HR，0.92[95%CI，0.70-1.20]；P=0.52），颅内出血风险无显著增加。
结论
在 TST 试验（针对卒中的治疗目标）中，与 100±10mg/dL 相比，使用他汀类药物联合依折麦布将 LDL 胆固醇目标值降至<70mg/dL 可一致降低随后发生卒中的风险。
注册
网址：https://www.
临床试验
gov；唯一标识符：NCT01252875。网址：clinicaltrialsregister.eu；唯一标识符：EUDRACT2009-A01280-57。
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