Jiang He1, Yonghong Zhang2, Tan Xu3, Qi Zhao4, Dali Wang5, Chung-Shiuan Chen4, Weijun Tong3, Changjie Liu6, Tian Xu3, Zhong Ju7, Yanbo Peng5, Hao Peng3, Qunwei Li8, Deqin Geng9, Jintao Zhang10, Dong Li11, Fengshan Zhang12, Libing Guo13, Yingxian Sun14, Xuemei Wang15, Yong Cui16, Yongqiu Li17, Dihui Ma18, Guang Yang19, Yanjun Gao20, Xiaodong Yuan21, Lydia A Bazzano22, Jing Chen22. 1. Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China2Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana3Department of Medicine, Tulane Un. 2. Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China2Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana. 3. Department of Epidemiology, School of Public Health, Medical College of Soochow University, Suzhou, China. 4. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana. 5. Department of Neurology, Affiliated Hospital of Hebei United University, Hebei, China. 6. Department of Neurology, Yutian County Hospital, Hebei, China. 7. Department of Neurology, Kerqin District First People's Hospital of Tongliao City, Inner Mongolia, China. 8. Department of Epidemiology, School of Public Health, Taishan Medical College, Shandong, China. 9. Department of Neurology, Affiliated Hospital of Xuzhou Medical College, Jiangsu, China. 10. Department of Neurology, the 88th Hospital of PLA, Shandong, China. 11. Department of Internal Medicine, Feicheng City People's Hospital, Shandong, China. 12. Department of Neurology, Tongliao Municipal Hospital, Inner Mongolia, China. 13. Department of Neurology, Siping Central Hospital, Jilin, China. 14. Department of Cardiology, the First Affiliated Hospital of China Medical University, Liaoning, China. 15. Department of Neurology, Jilin Central Hospital, Jilin, China. 16. Department of Neurology, General Hospital of First Automobile Works, Jilin, China. 17. Department of Neurology, Tangshan Worker's Hospital, Hebei, China. 18. Department of Neurology, the First Affiliated Hospital of Jilin University, Jilin, China. 19. Department of Neurology, the Second People's Hospital of Huaian City, Jiangsu, China. 20. Department of Neurology, Affiliated Hospital of Chengde Medical College, Hebei, China. 21. Department of Neurology, Kailuan General Hospital, Hebei, China. 22. Department of Epidemiology, Tulane University School of Public Health and Tropical Medicine, New Orleans, Louisiana3Department of Medicine, Tulane University School of Medicine, New Orleans, Louisiana4Tulane Hypertension and Renal Center of Excellence, Ne.
Abstract
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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01840072.
RCT Entities:
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. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01840072.
Authors: Sahar Soliman; Tauheed Ishrat; Abdelrahman Y Fouda; Ami Patel; Bindu Pillai; Susan C Fagan Journal: Transl Stroke Res Date: 2015-05-26 Impact factor: 6.829
Authors: Laura C Gioia; Rahel T Zewude; Mahesh P Kate; Kim Liss; Brian H Rowe; Brian Buck; Thomas Jeerakathil; Ken Butcher Journal: Neurology Date: 2016-05-18 Impact factor: 9.910