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. doi: 10.1056/NEJMoa2111437. Epub 2021 Aug 30.
The appropriate target for systolic blood pressure to reduce cardiovascular risk in older patients with hypertension remains unclear.
In 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.
Of 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.
In 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.).
对于患有高血压的老年患者，降低心血管风险的收缩压适当目标仍不明确。
在这项多中心、随机、对照试验中，我们将年龄在 60 岁至 80 岁之间的中国高血压患者随机分为收缩压目标值为 110 至＜130mmHg 的强化治疗组或目标值为 130 至＜150mmHg 的标准治疗组。主要结局是卒中、急性冠状动脉综合征（急性心肌梗死和不稳定型心绞痛住院）、急性失代偿性心力衰竭、冠状动脉血运重建、心房颤动或心血管原因导致的死亡组成的复合终点。
在 9624 名符合条件的患者中，有 8511 名患者入组参加了试验；其中 4243 名患者被随机分配至强化治疗组，4268 名患者被分配至标准治疗组。在 1 年的随访期间，强化治疗组的平均收缩压为 127.5mmHg，标准治疗组的平均收缩压为 135.3mmHg。在中位随访 3.34 年期间，强化治疗组有 147 例（3.5%）患者发生主要结局事件，标准治疗组有 196 例（4.6%）患者发生（风险比，0.74；95%置信区间[CI]，0.60 至 0.92；P=0.007）。主要结局的大多数单一组成部分的结果也倾向于强化治疗：卒中风险比为 0.67（95%CI，0.47 至 0.97），急性冠状动脉综合征为 0.67（95%CI，0.47 至 0.94），急性失代偿性心力衰竭为 0.27（95%CI，0.08 至 0.98），冠状动脉血运重建为 0.69（95%CI，0.40 至 1.18），心房颤动为 0.96（95%CI，0.55 至 1.68），心血管原因导致的死亡为 0.72（95%CI，0.39 至 1.32）。两组之间的安全性和肾脏结局结果没有显著差异，但强化治疗组的低血压发生率较高。
在患有高血压的老年患者中，与目标值为 130 至＜150mmHg 的标准治疗相比，收缩压目标值为 110 至＜130mmHg 的强化治疗可降低心血管事件的发生率。（由中国医学科学院等资助；STEP ClinicalTrials.gov 编号，NCT03015311。）
