Effects of Immediate Blood Pressure Reduction on Death and Major Disability in Patients With Acute Ischemic Stroke The CATIS Randomized Clinical Trial
Effects of Immediate Blood Pressure Reduction on Death and Major Disability in Patients With Acute Ischemic Stroke The CATIS Randomized Clinical Trial
复制标题
立即降压对急性缺血性中风患者死亡和严重残疾的影响 CATIS 随机临床试验
DOI：
10.1001/jama.2013.282543
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发表时间：
2014-02-05
影响因子：
120.7
通讯作者：
Chen, Jing
中科院分区：
文献类型：
--
作者：
He, Jiang;Zhang, Yonghong;Chen, Jing
虽然降低血压对脑卒中一级和二级预防的益处已经确立，但抗高血压治疗在急性缺血性脑卒中患者中的效果尚不确定。目的：评价急性缺血性脑卒中患者立即降低血压是否会减少14天或出院时的死亡和主要残疾。中国急性缺血性卒中降压试验是一项单盲、盲法终点随机临床试验，在4071例发病48小时内未溶栓的缺血性卒中患者中进行，收缩压升高。2009年8月至2013年5月期间，患者从中国的26家医院招募。患者（n = 2038）被随机分配接受降压治疗（目标是在随机分组后的前24小时内将收缩压降低10%至25%，在7天内使血压低于140/90 mm Hg，并在住院期间维持这一水平）或在住院期间停用所有降压药物（对照组）（n = 2033）。主要结局和测量主要结局是14天或出院时死亡和主要残疾的合并（修正Rankin量表评分>= 3）。结果降压治疗组的平均收缩压在24小时内从166.7 mm Hg降至144.7 mm Hg(-12.7%)，对照组的平均收缩压在随机分组后24小时内从165.6 mm Hg降至152.9 mm Hg(-7.2%)（差异为-5.5%[95% CI, -4.9 ~ -6.1%]；绝对差异为-9.1 mm Hg [95% CI, -10.2 ~ -8.1]; P < .001）。随机分组后第7天，降压治疗组平均收缩压为137.3 mm Hg，对照组平均收缩压为146.5 mm Hg（差异为-9.3 mm Hg [95% CI, -10.1 ~ -8.4]; P < .001）。在14天或出院时，治疗组间的主要结局无差异（683个事件[降压治疗]vs 681个事件[对照组]；优势比为1.00 [95% CI, 0.88 ~ 1.14]; P = 0.98）。治疗后3个月随访时，死亡和主要残疾的次要综合结局在治疗组之间没有差异（500例事件[降压治疗]vs 502例事件[对照组]；优势比为0.99 [95% CI， 0.86至1.15];P = 0.93）。结论和相关性在急性缺血性卒中患者中，与不使用降压药物相比，使用降压药物降低血压并没有降低14天或出院时死亡和主要残疾的可能性。
IMPORTANCE Although the benefit of reducing blood pressure for primary and secondary prevention of stroke has been established, the effect of antihypertensive treatment in patients with acute ischemic stroke is uncertain.OBJECTIVE To evaluate whether immediate blood pressure reduction in patients with acute ischemic stroke would reduce death and major disability at 14 days or hospital discharge.DESIGN, SETTING, AND PARTICIPANTS The China Antihypertensive Trial in Acute Ischemic Stroke, a single-blind, blinded end-points randomized clinical trial, conducted among 4071 patients with nonthrombolysed ischemic stroke within 48 hours of onset and elevated systolic blood pressure. Patients were recruited from 26 hospitals across China between August 2009 and May 2013.INTERVENTIONS Patients (n = 2038) were randomly assigned to receive antihypertensive treatment (aimed at lowering systolic blood pressure by 10% to 25% within the first 24 hours after randomization, achieving blood pressure less than 140/90 mm Hg within 7 days, and maintaining this level during hospitalization) or to discontinue all antihypertensive medications (control) during hospitalization (n = 2033).MAIN OUTCOMES AND MEASURES Primary outcome was a combination of death and major disability (modified Rankin Scale score >= 3) at 14 days or hospital discharge.RESULTS Mean systolic blood pressure was reduced from 166.7 mm Hg to 144.7 mm Hg (-12.7%) within 24 hours in the antihypertensive treatment group and from 165.6 mm Hg to 152.9 mm Hg (-7.2%) in the control group within 24 hours after randomization (difference, -5.5%[95% CI, -4.9 to -6.1%]; absolute difference, -9.1 mm Hg [95% CI, -10.2 to -8.1]; P < .001). Mean systolic blood pressure was 137.3 mm Hg in the antihypertensive treatment group and 146.5 mm Hg in the control group at day 7 after randomization (difference, -9.3 mm Hg [95% CI, -10.1 to -8.4]; P < .001). The primary outcome did not differ between treatment groups (683 events [antihypertensive treatment] vs 681 events [control]; odds ratio, 1.00 [95% CI, 0.88 to 1.14]; P = .98) at 14 days or hospital discharge. The secondary composite outcome of death and major disability at 3-month posttreatment follow-up did not differ between treatment groups (500 events [antihypertensive treatment] vs 502 events [control]; odds ratio, 0.99 [95% CI, 0.86 to 1.15]; P = .93).CONCLUSION AND RELEVANCE Among patients with acute ischemic stroke, blood pressure reduction with antihypertensive medications, compared with the absence of hypertensive medication, did not reduce the likelihood of death and major disability at 14 days or hospital discharge.