Assessment of Risk of Harm Associated With Intensive Blood Pressure Management Among Patients With Hypertension Who Smoke A Secondary Analysis of the Systolic Blood Pressure Intervention Trial
Assessment of Risk of Harm Associated With Intensive Blood Pressure Management Among Patients With Hypertension Who Smoke A Secondary Analysis of the Systolic Blood Pressure Intervention Trial
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DOI：
10.1001/jamanetworkopen.2019.0005
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发表时间：
2019-03-01
影响因子：
13.8
通讯作者：
Baum, Aaron
中科院分区：
文献类型：
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作者：
Scarpa, Joseph;Bruzelius, Emilie;Baum, Aaron
重要性随机收缩压干预试验(SPRINT)表明，降低成年高血压患者的收缩压目标总体上可以降低心血管疾病的发病率和死亡率。然而，强化血压控制的总体益处是否掩盖了风险的重要异质性尚不清楚。目的为了检验这样的假设，即在Sprint中观察到的总体益处掩盖了强化血压控制中的重要异质性。设计、设置和参与者对来自Sprint的9361名参与者的数据进行了探索性、假设生成、特别、二次分析，使用一半的试验数据，使用随机的基于森林的分析来确定潜在的异质性治疗效果。用COX比例风险回归模型检验剩余数据的潜在异质性处理效应。最初的试验是在2010年11月至2013年3月期间在美国102个地点进行的。这项分析是在2016年11月至2017年8月进行的。干预参与者被分配了低于120 mm Hg(干预治疗)或小于140 mm Hg(标准治疗)的收缩压目标。主要结果和测量主要综合心血管结果是心肌梗死、其他急性冠脉综合征、中风、心力衰竭或死于心血管原因。结果9361名短跑参与者中，466名(5.0%)目前吸烟者在基线时收缩压大于144 mm Hg，230名(49.4%)随机进入训练数据集，236名(50.6%)随机进入测试数据集；286名(61.4%)为男性，平均年龄为60.7(7.2)岁。2个协变量(即基线吸烟状态和收缩压)的组合区分了受干预影响不同的参与者。在测试数据中，COX比例风险模型显示，在基线时，当前吸烟者的收缩压大于144毫米汞柱的参与者中，需要伤害43.7的数量才能在3.3年内导致1起事件(介入治疗的主要结果事件的10.9%[110例中的12例]，标准治疗的4.8%[6例]；危险比10.6；95%的可信区间，1.3-86.1；P=.03)。这一亚组还与在强化血压控制下发生急性肾损伤的可能性更高(介入治疗的急性肾损伤事件的发生率为10.0%[11/110]，而标准治疗的急性肾损害事件的发生率为3.2%[4/126]；风险比为9.4；95%的可信区间为1.2-77.3；P=0.04)。结论在对Sprint数据的二次分析中，基线收缩压大于144 mm Hg的当前吸烟者在强化治疗组的心血管事件发生率高于标准治疗组。需要进一步的研究来评估高血压吸烟者强化血压控制的潜在权衡。
IMPORTANCE The randomized Systolic Blood Pressure Intervention Trial (SPRINT) showed that lowering systolic blood pressure targets for adults with hypertension reduces cardiovascular morbidity and mortality in general. However, whether the overall benefit from intensive blood pressure control masks important heterogeneity in risk is unknown.OBJECTIVE To test the hypothesis that the overall benefit observed in SPRINT masked important heterogeneity in risk from intensive blood pressure control.DESIGN, SETTING, AND PARTICIPANTS In this exploratory, hypothesis-generating, ad hoc, secondary analysis of data obtained from 9361 participants in SPRINT, a random forest-based analysis was used to identify potential heterogeneous treatment effects using half of the trial data. Cox proportional hazards regression models were applied to test potential heterogeneous treatment effects on the remaining data. The original trial was conducted at 102 sites in the United States between November 2010 and March 2013. This analysis was conducted between November 2016 and August 2017.INTERVENTIONS Participants were assigned a systolic blood pressure target of less than 120 mm Hg (intervention treatment) or of less than 140 mm Hg (standard treatment).MAIN OUTCOMES AND MEASURES The primary composite cardiovascular outcome was myocardial infarction, other acute coronary syndromes, stroke, heart failure, or death from cardiovascular causes.RESULTS Of 9361 participants in SPRINT, 466 participants (5.0%) were current smokers with systolic blood pressure greater than 144 mm Hg at baseline, with 230 participants (49.4%) randomized to the training data set and 236 participants (50.6%) randomized to the testing data set; 286 participants (61.4%) were male, and the mean (SD) age was 60.7 (7.2) years. Combinations of 2 covariates (ie, baseline smoking status and systolic blood pressure) distinguished participants who were differentially affected by the intervention. In the testing data, Cox proportional hazards models for the primary outcome revealed a number needed to harm of 43.7 to cause 1 event across 3.3 years among participants who, at baseline, were current smokers with systolic blood pressure greater than 144 mm Hg (10.9%[12 of 110] of primary outcome events for intervention treatment vs 4.8%[6 of 126] for standard treatment; hazard ratio, 10.6; 95% CI, 1.3-86.1; P=.03). This subgroup was also associated with a higher likelihood to experience acute kidney injury under intensive blood pressure control (with a frequency of 10.0%[11 of 110] of acute kidney injury events for intervention treatment vs 3.2%[4 of 126] for standard treatment; hazard ratio, 9.4; 95% CI, 1.2-77.3; P=.04).CONCLUSIONS AND RELEVANCE In this secondary analysis of SPRINT data, current smokers with a baseline systolic blood pressure greater than 144 mm Hg had a higher rate of cardiovascular events in the intensive treatment group vs the standard treatment group. Further research is needed to evaluate the potential tradeoffs of intensive blood pressure control in hypertensive smokers.