A Randomized Trial of Intensive versus Standard Blood-Pressure Control.
A Randomized Trial of Intensive versus Standard Blood-Pressure Control.
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DOI：
10.1056/nejmoa1511939
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发表时间：
2015-11-26
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影响因子：
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通讯作者：
Ambrosius WT
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作者：
SPRINT Research Group;Wright JT Jr;Williamson JD;Whelton PK;Snyder JK;Sink KM;Rocco MV;Reboussin DM;Rahman M;Oparil S;Lewis CE;Kimmel PL;Johnson KC;Goff DC Jr;Fine LJ;Cutler JA;Cushman WC;Cheung AK;Ambrosius WT
降低非糖尿病患者心血管发病率和死亡率的最合适的收缩压目标仍不确定。我们将 9361 名收缩压等于或高于 130 毫米汞柱且心血管风险增加但没有糖尿病的患者随机分配到收缩压目标低于 120 毫米汞柱（强化治疗）或低于 140 毫米汞柱的目标（标准治疗）。主要复合结局是心肌梗死、其他急性冠状动脉综合征、中风、心力衰竭或心血管原因死亡。 1 年时，强化治疗组的平均收缩压为 121.4 mm Hg，标准治疗组的平均收缩压为 136.2 mm Hg。中位随访3.26年后，由于强化治疗组的主要复合结局发生率显着低于标准治疗组（每年1.65% vs. 2.19%；强化治疗的风险比为0.75；95%置信区间[CI]为0.64至0.89；P<0.001），干预措施提前停止。强化治疗组的全因死亡率也显着降低（风险比，0.73；95% CI，0.60至0.90；P = 0.003）。强化治疗组中低血压、晕厥、电解质异常和急性肾损伤或衰竭等严重不良事件的发生率高于标准治疗组，但不包括伤害性跌倒。在心血管事件高危但无糖尿病的患者中，与收缩压低于140毫米汞柱相比，将收缩压控制在低于120毫米汞柱可以降低致命和非致命性主要心血管事件以及全因死亡的发生率，尽管在强化治疗组中观察到某些不良事件的发生率明显较高。 （由美国国立卫生研究院资助；ClinicalTrials.gov 编号，NCT01206062。）
The most appropriate targets for systolic blood pressure to reduce cardiovascular morbidity and mortality among persons without diabetes remain uncertain. We randomly assigned 9361 persons with a systolic blood pressure of 130 mm Hg or higher and an increased cardiovascular risk, but without diabetes, to a systolic blood-pressure target of less than 120 mm Hg (intensive treatment) or a target of less than 140 mm Hg (standard treatment). The primary composite outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes. At 1 year, the mean systolic blood pressure was 121.4 mm Hg in the intensive-treatment group and 136.2 mm Hg in the standard-treatment group. The intervention was stopped early after a median follow-up of 3.26 years owing to a significantly lower rate of the primary composite outcome in the intensive-treatment group than in the standard-treatment group (1.65% per year vs. 2.19% per year; hazard ratio with intensive treatment, 0.75; 95% confidence interval [CI], 0.64 to 0.89; P<0.001). All-cause mortality was also significantly lower in the intensive-treatment group (hazard ratio, 0.73; 95% CI, 0.60 to 0.90; P = 0.003). Rates of serious adverse events of hypotension, syncope, electrolyte abnormalities, and acute kidney injury or failure, but not of injurious falls, were higher in the intensive-treatment group than in the standard-treatment group. Among patients at high risk for cardiovascular events but without diabetes, targeting a systolic blood pressure of less than 120 mm Hg, as compared with less than 140 mm Hg, resulted in lower rates of fatal and nonfatal major cardiovascular events and death from any cause, although significantly higher rates of some adverse events were observed in the intensive-treatment group. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01206062.)