Randomized Controlled Trial Comparative Study
- Weili Zhang, Shuyuan Zhang, Yue Deng, Shouling Wu, Jie Ren, Gang Sun, Jinfeng Yang, Yinong Jiang, Xinjuan Xu, Tzung-Dau Wang, Youren Chen, Yufeng Li, Lianchen Yao, Dianfang Li, Lixin Wang, Xiaomei Shen, Xinhua Yin, Wei Liu, Xiaoyang Zhou, Bingpo Zhu, Zihong Guo, Hualing Liu, Xiaoping Chen, Yingqing Feng, Gang Tian, Xiuyin Gao, Kazuomi Kario, Jun Cai, and STEP Study Group.
- From the Hypertension Center, FuWai Hospital, State Key Laboratory of Cardiovascular Disease, National Center for Cardiovascular Diseases, Peking Union Medical College, Chinese Academy of Medical Sciences (W.Z., S.Z., Y.D., J.C.), Peking Union Medical College Hospital (S.Z.), Beijing Pinggu Hospital (Y.L.), and Beijing Hospital (W.L.), Beijing, Kailuan General Hospital, Tangshan (S.W.), Shanxi Bethune Hospital, Shanxi Academy of Medical Sciences (J.R.), and the First Affiliated Hospital of Shanxi Medical University (X.S.), Taiyuan, the Second Affiliated Hospital of Baotou Medical College, Baotou (G.S.), the People's Hospital of Ji Xian District, Tianjin (J.Y.), the First Affiliated Hospital of Dalian Medical University (Y.J.) and Omron Dalian (X.G.), Dalian, the First Affiliated Hospital of Xinjiang Medical University, Urumqi (X.X.), the Second Affiliated Hospital of Medical College Shantou University, Shantou (Y.C.), Benxi Railway Hospital, Benxi (L.Y.), Hongxinglong Center Hospital, Shuangyashan (D.L.), the First Affiliated Hospital of Hebei North University, Zhangjiakou (L.W.), the First Affiliated Hospital of Harbin Medical University, Harbin (X.Y.), Renmin Hospital of Wuhan University, Wuhan (X.Z.), Kang Ya Hospital, Yiyang (B.Z.), FuWai Yunnan Cardiovascular Hospital, Kunming (Z.G.), Zhoukou City Central Hospital, Zhoukou (H.L.), West China Hospital, Sichuan University, Chengdu (X.C.), Guangdong Cardiovascular Institute, Guangzhou (Y.F.), and the First Affiliated Hospital of Xi'an Jiaotong University, Xi'an (G.T.) - all in China; the Cardiovascular Center and Divisions of Cardiology and Hospital Medicine, Department of Internal Medicine, National Taiwan University Hospital, Taipei (T.-D.W.); and Jichi Medical University School of Medicine, Shimotsuke, Japan (K.K.).
- N. Engl. J. Med. 2021 Sep 30; 385 (14): 1268-1279.
BackgroundThe appropriate target for systolic blood pressure to reduce cardiovascular risk in older patients with hypertension remains unclear.MethodsIn this multicenter, randomized, controlled trial, we assigned Chinese patients 60 to 80 years of age with hypertension to a systolic blood-pressure target of 110 to less than 130 mm Hg (intensive treatment) or a target of 130 to less than 150 mm Hg (standard treatment). The primary outcome was a composite of stroke, acute coronary syndrome (acute myocardial infarction and hospitalization for unstable angina), acute decompensated heart failure, coronary revascularization, atrial fibrillation, or death from cardiovascular causes.ResultsOf the 9624 patients screened for eligibility, 8511 were enrolled in the trial; 4243 were randomly assigned to the intensive-treatment group and 4268 to the standard-treatment group. At 1 year of follow-up, the mean systolic blood pressure was 127.5 mm Hg in the intensive-treatment group and 135.3 mm Hg in the standard-treatment group. During a median follow-up period of 3.34 years, primary-outcome events occurred in 147 patients (3.5%) in the intensive-treatment group, as compared with 196 patients (4.6%) in the standard-treatment group (hazard ratio, 0.74; 95% confidence interval [CI], 0.60 to 0.92; P = 0.007). The results for most of the individual components of the primary outcome also favored intensive treatment: the hazard ratio for stroke was 0.67 (95% CI, 0.47 to 0.97), acute coronary syndrome 0.67 (95% CI, 0.47 to 0.94), acute decompensated heart failure 0.27 (95% CI, 0.08 to 0.98), coronary revascularization 0.69 (95% CI, 0.40 to 1.18), atrial fibrillation 0.96 (95% CI, 0.55 to 1.68), and death from cardiovascular causes 0.72 (95% CI, 0.39 to 1.32). The results for safety and renal outcomes did not differ significantly between the two groups, except for the incidence of hypotension, which was higher in the intensive-treatment group.ConclusionsIn older patients with hypertension, intensive treatment with a systolic blood-pressure target of 110 to less than 130 mm Hg resulted in a lower incidence of cardiovascular events than standard treatment with a target of 130 to less than 150 mm Hg. (Funded by the Chinese Academy of Medical Sciences and others; STEP ClinicalTrials.gov number, NCT03015311.).Copyright © 2021 Massachusetts Medical Society.
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