From the Department of Cerebrovascular Medicine, National Cerebral and Cardiovascular Center, Suita, Japan (S.W., M.K., K.M., K.T., R.S.).
Foundation for Biomedical Research and Innovation at Kobe, Translational Research Center for Medical Innovation, Japan (T.K.).
Stroke. 2019 Jun;50(6):1586-1589. doi: 10.1161/STROKEAHA.119.024968. Epub 2019 Apr 30.
Background and Purpose- As a prespecified post hoc analysis of the J-STARS (Japan Statin Treatment Against Recurrent Stroke) Echo Study, the 5-year stroke recurrence rate according to the baseline mean carotid intima-media thickness (IMT) with and without pravastatin treatment was investigated. Methods- Patients were randomly assigned to receive pravastatin 10 mg/day (pravastatin group) or control group (nonstatin treatment; 1:1) for 5 years. Baseline mean IMT of the common carotid artery was measured by ultrasonography. Cox proportional hazards models were used to investigate whether the stroke (any ischemic stroke, atherothrombotic brain infarction, or lacunar infarction) recurrence rate was different according to tertiles of baseline mean IMT. Results- A total of 793 patients, including 388 in the pravastatin group and 405 in the control group, were investigated. In the control group, Cox proportional hazards models showed that participants in the highest tertile IMT group (≥0.931 mm) had a higher rate of atherothrombotic brain infarction than those in the lowest tertile IMT group (<0.812 mm; [hazard ratio, 9.08; 95% CI, 1.15-71.43]). Patients in the pravastatin group had a lower risk of atherothrombotic brain infarction than those in the control group only in the highest tertile IMT group by the log-rank test ( P value=0.045). Conclusions- Long-term pravastatin administration may prevent the occurrence of atherothrombotic brain infarction in noncardioembolic infarction patients with the highest tertile IMT. Clinical Trial Registration- URL: https://www.clinicaltrials.gov . Unique identifier: NCT00361530.
背景与目的- 本研究为 J-STARS(日本他汀类药物治疗复发性卒中)回声研究的预设事后分析,通过比较基线时平均颈动脉内膜中层厚度(IMT)有无普伐他汀治疗情况下的 5 年卒中复发率,探讨了该因素与卒中复发的相关性。方法- 患者被随机分配接受普伐他汀 10 mg/天(普伐他汀组)或对照组(非他汀治疗;1:1)治疗 5 年。通过超声检查测量颈总动脉的基线平均 IMT。采用 Cox 比例风险模型探讨根据基线平均 IMT 的三分位值,卒中(任何缺血性卒、动脉粥样硬化血栓性脑梗死或腔隙性梗死)复发率是否不同。结果- 共纳入 793 例患者,其中普伐他汀组 388 例,对照组 405 例。在对照组中,Cox 比例风险模型显示,IMT 最高三分位组(≥0.931 mm)患者发生动脉粥样硬化血栓性脑梗死的风险高于 IMT 最低三分位组(<0.812 mm;[风险比,9.08;95%置信区间,1.15-71.43])。通过对数秩检验,普伐他汀组患者发生动脉粥样硬化血栓性脑梗死的风险仅在 IMT 最高三分位组中低于对照组(P 值=0.045)。结论- 长期应用普伐他汀可能预防 IMT 最高三分位的非心源性栓塞性梗死患者发生动脉粥样硬化血栓性脑梗死。临床试验注册- URL:https://www.clinicaltrials.gov。唯一识别码:NCT00361530。