William J He1,2, Chongke Zhong1,3, Tan Xu3, Dali Wang4, Yingxian Sun5, Xiaoqing Bu3, Chung-Shiuan Chen1, Jinchao Wang6, Zhong Ju7, Qunwei Li8, Jintao Zhang9, Deqin Geng10, Jianhui Zhang11, Dong Li12, Yongqiu Li13, Xiaodong Yuan14, Yonghong Zhang3, Tanika N Kelly1. 1. Department of Epidemiology, School of Public Health and Tropical Medicine. 2. Johns Hopkins University, Krieger School of Arts and Sciences, Baltimore, Maryland, USA. 3. Department of Epidemiology and Jiangsu Key Laboratory of Preventive and Translational Medicine for Geriatric Diseases, School of Public Health, Medical College of Soochow University, Jiangsu. 4. Department of Neurology, Affiliated Hospital of North China University of Science and Technology, Hebei. 5. Department of Cardiology, the First Affiliated Hospital of China Medical University, Liaoning. 6. Department of Neurology, Yutian County Hospital, Hebei. 7. Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner Mongolia. 8. Department of Epidemiology, School of Public Health, Taishan Medical College. 9. Department of Neurology, the 88th Hospital of PLA, Shandong. 10. Department of Neurology, Affiliated Hospital of Xuzhou Medical College, Jiangsu. 11. Department of Neurology, Tongliao Municipal Hospital, Inner Mongolia. 12. Department of internal medicine, Feicheng city People's hospital, Shandong. 13. Department of Neurology, Tangshan Worker's Hospital. 14. Department of Neurology, Kailuan General Hospital, Hebei, China.
Abstract
BACKGROUND: We studied the effect of early antihypertensive treatment on death, major disability, and vascular events among patients with acute ischemic stroke according to their baseline SBP. METHODS: We randomly assigned 4071 acute ischemic stroke patients with SBP between 140 and less than 220 mmHg to receiveantihypertensive treatment or to discontinue all antihypertensive medications during hospitalization. A composite primary outcome of death and major disability and secondary outcomes were compared between treatment and control stratified by baseline SBP levels of less than 160, 160-179, and at least 180 mmHg. RESULTS: At 24 h after randomization, differences in SBP reductions were 8.8, 8.6 and 7.8 mmHg between the antihypertensive treatment and control groups among patients with baseline SBP less than 160, 160-179, and at least 180 mmHg, respectively (P < 0.001 among subgroups). At day 14 or hospital discharge, the primary and secondary outcomes were not significantly different between the treatment and control groups among subgroups. However, there was a significant interaction between antihypertensive treatment and baseline SBP subgroups on death (P = 0.02): odds ratio (95% CI) of 2.42 (0.74-7.89) in patients with baseline SBP less than 60 mmHg and 0.34 (0.11-1.09) in those with baseline SBP at least 180 mmHg. At the 3-month follow-up, the primary and secondary clinical outcomes were not significantly different between the treatment and control groups by baseline SBP levels. CONCLUSION: Early antihypertensive treatment had a neutral effect on clinical outcomes among acute ischemic stroke patients with various baseline SBP levels. Future clinical trials are warranted to test BP-lowering effects in acute ischemic stroke patients by baseline SBP levels. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01840072.
RCT Entities:
BACKGROUND: We studied the effect of early antihypertensive treatment on death, major disability, and vascular events among patients with acute ischemic stroke according to their baseline SBP. METHODS: We randomly assigned 4071 acute ischemic strokepatients with SBP between 140 and less than 220 mmHg to receive antihypertensive treatment or to discontinue all antihypertensive medications during hospitalization. A composite primary outcome of death and major disability and secondary outcomes were compared between treatment and control stratified by baseline SBP levels of less than 160, 160-179, and at least 180 mmHg. RESULTS: At 24 h after randomization, differences in SBP reductions were 8.8, 8.6 and 7.8 mmHg between the antihypertensive treatment and control groups among patients with baseline SBP less than 160, 160-179, and at least 180 mmHg, respectively (P < 0.001 among subgroups). At day 14 or hospital discharge, the primary and secondary outcomes were not significantly different between the treatment and control groups among subgroups. However, there was a significant interaction between antihypertensive treatment and baseline SBP subgroups on death (P = 0.02): odds ratio (95% CI) of 2.42 (0.74-7.89) in patients with baseline SBP less than 60 mmHg and 0.34 (0.11-1.09) in those with baseline SBP at least 180 mmHg. At the 3-month follow-up, the primary and secondary clinical outcomes were not significantly different between the treatment and control groups by baseline SBP levels. CONCLUSION: Early antihypertensive treatment had a neutral effect on clinical outcomes among acute ischemic strokepatients with various baseline SBP levels. Future clinical trials are warranted to test BP-lowering effects in acute ischemic strokepatients by baseline SBP levels. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT01840072.
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