Suppr超能文献

伴有或不伴有高血压病史的急性缺血性脑卒中患者的即刻降压治疗:CATIS 随机临床试验的二次分析。

Immediate Antihypertensive Treatment for Patients With Acute Ischemic Stroke With or Without History of Hypertension: A Secondary Analysis of the CATIS Randomized Clinical Trial.

机构信息

Department of Epidemiology, School of Public Health and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, Medical College of Soochow University, Suzhou, China.

Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana.

出版信息

JAMA Netw Open. 2019 Jul 3;2(7):e198103. doi: 10.1001/jamanetworkopen.2019.8103.

Abstract

IMPORTANCE

Clinical trials have generally shown a neutral effect of early blood pressure (BP) decreases on clinical outcomes after acute ischemic stroke. Whether the effect of early antihypertensive therapy differs for patients with ischemic stroke with or without prior hypertension is unclear.

OBJECTIVE

To investigate the association between immediate antihypertensive treatment and patient outcomes according to the presence or absence of hypertension before stroke onset.

DESIGN, SETTING, AND PARTICIPANTS: This study was a prespecified subgroup analysis of the China Antihypertensive Trial in Acute Ischemic Stroke (CATIS), a multicenter, single-blind, blinded end-points randomized clinical trial of 4071 patients with acute ischemic stroke and elevated systolic BP. Patients were recruited from August 2009 to May 2013, and this statistical analysis was performed using the intention-to-treat population from January to October 2018.

INTERVENTIONS

Participants were randomly assigned to receive antihypertensive treatment (aimed at decreasing systolic BP by 10%-25% within the first 24 hours after randomization, achieving systolic BP <140 mm Hg and diastolic BP <90 mm Hg within 7 days, and maintaining this level during hospitalization) or to the control arm (discontinued all antihypertensive medications).

MAIN OUTCOMES AND MEASURES

Primary outcome was a combination of death and major disability (modified Rankin Scale score ≥3; range 0-6, with higher values indicating greater disability) at 14 days or hospital discharge.

RESULTS

In total, 2038 patients were randomized to receive antihypertensive treatment, and 2033 patients were randomized to the control group. The mean (SD) age was 62.0 (10.9) years, and 2604 participants (64.0%) were men. At day 14 or hospital discharge, the primary outcome was not different between the treatment and control groups among patients with or without prior hypertension (P = .97 for homogeneity): odds ratios (ORs) associated with treatment were 1.00 (95% CI, 0.87-1.16) for patients with prior hypertension and 1.00 (95% CI, 0.75-1.32) for patients without. Early antihypertensive treatment was associated with different rates of 3-month recurrent stroke (patients with hypertension: OR, 0.44; 95% CI, 0.25-0.77 vs without hypertension: OR, 3.43; 95% CI, 0.94-12.55; P = .005 for homogeneity) and vascular events (patients with hypertension: OR, 0.66; 95% CI, 0.43-1.02 vs those without hypertension: OR, 1.91; 95% CI, 0.75-4.83; P = .04 for homogeneity) by hypertension history.

CONCLUSIONS AND RELEVANCE

Among patients with acute ischemic stroke, early antihypertensive treatment was not associated with different death and major disability outcomes by hypertension history. However, early antihypertension therapy was associated with a decreased rate of recurrent stroke among patients with a history of hypertension and may inform future studies in the optimal approach to hypertension management in the setting of acute ischemic stroke.

TRIAL REGISTRATION

ClinicalTrials.gov identifier: NCT01840072.

摘要

重要性

临床试验普遍表明急性缺血性脑卒中后早期血压降低对临床结局无明显影响。对于有或无既往高血压的缺血性脑卒中患者,早期降压治疗的效果是否存在差异尚不清楚。

目的

根据发病前是否存在高血压,研究即刻降压治疗与患者结局之间的关系。

设计、地点和参与者:本研究是中国急性缺血性脑卒中降压试验(CATIS)的一个预设亚组分析,该试验是一项多中心、单盲、盲终点随机临床试验,共纳入 4071 例急性缺血性脑卒中且伴有收缩压升高的患者。患者于 2009 年 8 月至 2013 年 5 月招募,本统计分析采用 2018 年 1 月至 10 月的意向治疗人群。

干预

参与者被随机分配接受降压治疗(目标是在随机分组后 24 小时内使收缩压降低 10%-25%,在 7 天内使收缩压<140mmHg 和舒张压<90mmHg,并在住院期间维持该水平)或对照组(停止所有降压药物)。

主要结局和测量指标

主要结局是 14 天或出院时死亡和主要残疾(改良 Rankin 量表评分≥3;范围 0-6,分值越高表示残疾越严重)的组合。

结果

共有 2038 例患者被随机分配接受降压治疗,2033 例患者被随机分配至对照组。平均(SD)年龄为 62.0(10.9)岁,2604 例(64.0%)参与者为男性。在第 14 天或出院时,治疗组和对照组在有或无既往高血压的患者中主要结局无差异(同质性检验 P=0.97):治疗相关的比值比(OR)分别为既往高血压患者 1.00(95%CI,0.87-1.16)和无既往高血压患者 1.00(95%CI,0.75-1.32)。早期降压治疗与 3 个月内复发卒中(既往高血压患者:OR,0.44;95%CI,0.25-0.77;无高血压患者:OR,3.43;95%CI,0.94-12.55;同质性检验 P=0.005)和血管事件(既往高血压患者:OR,0.66;95%CI,0.43-1.02;无高血压患者:OR,1.91;95%CI,0.75-4.83;同质性检验 P=0.04)的发生率存在差异。

结论和相关性

在急性缺血性脑卒中患者中,根据高血压病史,早期降压治疗与死亡和主要残疾结局无差异。然而,早期降压治疗与有高血压病史患者的卒中复发率降低有关,这可能为急性缺血性脑卒中时高血压管理的最佳方法提供信息。

试验注册

ClinicalTrials.gov 标识符:NCT01840072。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e6ef/6669782/db453ea0dfda/jamanetwopen-2-e198103-g001.jpg

文献AI研究员

20分钟写一篇综述,助力文献阅读效率提升50倍。

立即体验

用中文搜PubMed

大模型驱动的PubMed中文搜索引擎

马上搜索

文档翻译

学术文献翻译模型,支持多种主流文档格式。

立即体验