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评估强化血压控制对剩余预期寿命的长期获益:收缩压干预试验(SPRINT)的二次分析。

Assessment of Long-term Benefit of Intensive Blood Pressure Control on Residual Life Span: Secondary Analysis of the Systolic Blood Pressure Intervention Trial (SPRINT).

机构信息

Cardiovascular Division, Brigham and Women's Hospital, Boston, Massachusetts.

Section for Research, Division of General Medicine, Beth Israel Deaconess Medical Center, Boston, Massachusetts.

出版信息

JAMA Cardiol. 2020 May 1;5(5):576-581. doi: 10.1001/jamacardio.2019.6192.

Abstract

IMPORTANCE

High blood pressure (BP) is a leading contributor to premature mortality worldwide. The Systolic Blood Pressure Intervention Trial (SPRINT) demonstrated a 27% reduction in all-cause death with intensive (vs standard) BP control. However, traditional reporting of survival benefits is not readily interpretable outside medical communities.

OBJECTIVE

To estimate residual life span and potential survival gains with intensive compared with standard BP control in the SPRINT trial using validated nonparametric age-based methods.

DESIGN, SETTING, AND PARTICIPANTS: This secondary analysis of data from an open-label randomized clinical trial included data from 102 enrolling clinical sites in the United States. Adults who were 50 years or older, were at high cardiovascular risk but without diabetes, and had a screening systolic BP between 130 and 180 mm Hg were enrolled between November 2010 and March 2013. Data analysis occurred from May 2019 to December 2019.

INTERVENTIONS

A 1:1 randomization to intensive (target, <120 mm Hg) or standard (target, <140 mm Hg) systolic BP targets.

MAIN OUTCOMES AND MEASURES

We calculated age-based estimates of projected survival (at a given age) using baseline age rather than time from randomization as the time axis. In each treatment arm at every year of age, residual life span was estimated using the area under the survival curve, up to a maximum of 95 years. Differences in areas under the survival curves reflect the estimated treatment benefits on projected survival.

RESULTS

A total of 9361 adults were enrolled (mean [SD] age at randomization, 68 [9] years; 6029 [64.4%] were men; 5399 [57.7%] were non-Hispanic white individuals). Mean survival benefits with intensive vs standard BP control ranged from 6 months to up to 3 years. At age 50 years, the estimated residual survival was 37.3 years with intensive treatment and 34.4 years with standard treatment (difference, 2.9 years [95% CI, 0.9-5.0 years]; P = .008). At age 65 years, residual survival was 24.5 years with intensive treatment and 23.3 years with standard treatment (difference, 1.1 years [95% CI, 0.1-2.1 years]; P = .03). Absolute survival gains with intensive vs standard BP control decreased with age, but the relative benefits were consistent (4% to 9%).

CONCLUSIONS AND RELEVANCE

Intensive BP control improves projected survival by 6 months to 3 years among middle-aged and older adults at high cardiovascular risk but without diabetes mellitus. These post hoc actuarial analyses from SPRINT support the survival benefits of intensive BP control, especially among middle-aged adults at risk.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01206062.

摘要

重要性

高血压(BP)是全球导致过早死亡的主要原因。收缩压干预试验(SPRINT)表明,通过强化(与标准相比)血压控制,可以降低 27%的全因死亡率。然而,传统的生存获益报告在医学社区之外不易理解。

目的

使用经过验证的基于年龄的非参数方法,估计 SPRINT 试验中强化与标准血压控制相比的剩余预期寿命和潜在生存获益。

设计、地点和参与者:这是一项对在美国 102 个入组临床中心开展的开放标签随机临床试验数据进行的二次分析。纳入的成年人年龄在 50 岁及以上,心血管风险较高但没有糖尿病,且筛查时收缩压在 130 至 180mmHg 之间。研究于 2010 年 11 月至 2013 年 3 月期间入组,数据分析于 2019 年 5 月至 12 月进行。

干预

1:1 随机分为强化(目标,<120mmHg)或标准(目标,<140mmHg)收缩压目标。

主要结局和测量指标

我们使用基线年龄而不是随机化后的时间作为时间轴,计算了基于年龄的预期生存估计(在特定年龄)。在每个治疗臂的每一年龄,使用生存曲线下的面积来估计剩余寿命,最长可达 95 岁。生存曲线下面积的差异反映了对预期生存的治疗获益估计。

结果

共纳入 9361 名成年人(随机化时的平均[标准差]年龄,68[9]岁;6029[64.4%]为男性;5399[57.7%]为非西班牙裔白人)。与标准 BP 控制相比,强化 BP 控制的平均生存获益在 6 个月到 3 年之间。在 50 岁时,强化治疗的估计剩余生存为 37.3 年,标准治疗为 34.4 年(差异,2.9 年[95%CI,0.9-5.0 年];P=0.008)。在 65 岁时,强化治疗的剩余生存为 24.5 年,标准治疗为 23.3 年(差异,1.1 年[95%CI,0.1-2.1 年];P=0.03)。与标准 BP 控制相比,强化 BP 控制的绝对生存获益随年龄增加而降低,但相对获益保持一致(4%至 9%)。

结论和相关性

在心血管风险较高但没有糖尿病的中年和老年人群中,强化血压控制可将预期寿命提高 6 个月至 3 年。SPRINT 的这些事后分析支持强化血压控制的生存获益,尤其是在中年高危人群中。

试验注册

ClinicalTrials.gov 标识符:NCT01206062。

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