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强化与标准血压控制与新发左束支传导阻滞相关性的研究:SPRINT 随机临床试验的事后分析。

Association Between Intensive vs Standard Blood Pressure Control and Incident Left Ventricular Conduction Disease: A Post Hoc Analysis of the SPRINT Randomized Clinical Trial.

机构信息

Division of Cardiology, Department of Medicine, University of California San Francisco.

Department of Cardiology, Herlev and Gentofte Hospital, Copenhagen, Denmark.

出版信息

JAMA Cardiol. 2023 Jun 1;8(6):612-616. doi: 10.1001/jamacardio.2023.0845.

Abstract

IMPORTANCE

Left ventricular conduction disease predicts heart failure and death, and the only strategies to mitigate its effects involve implantation of a permanent pacemaker. There are currently no proven preventive strategies for this common condition.

OBJECTIVE

To determine the association between targeting intensive blood pressure (BP) control and the risk of developing left ventricular conduction disease.

DESIGN, SETTING, AND PARTICIPANTS: This was a post hoc analysis of the 2-arm multicenter Systolic Blood Pressure Intervention Trial (SPRINT), which recruited participants from 102 sites in the US and Puerto Rico and was conducted from November 2010 until August 2015. Adults 50 years and older with hypertension and at least 1 other cardiovascular risk factor were included. Participants with baseline left ventricular conduction disease, ventricular pacing, or ventricular pre-excitation were excluded for the current analysis. Data were analyzed from November 2021 to November 2022.

INTERVENTION

Participants were randomly assigned to a systolic BP target of less than 140 mm Hg (standard treatment group) or less than 120 mm Hg (intensive treatment group).

MAIN OUTCOME

The primary outcome was incident left ventricular conduction disease, including any fascicular or left bundle-branch block, assessed by serial electrocardiography. Incident right bundle-branch block was examined as a negative control.

RESULTS

Among 3918 participants randomized to standard treatment and 3956 to intensive treatment (mean [SD] age, 67.6 [9.2] years; 2815 [36%] female) monitored for a median [IQR] 3.5 (0.02-5.2) years, 203 developed left ventricular conduction disease. Older age (hazard ratio per 10-year increase [HR], 1.42; 95% CI, 1.21-1.67; P < .001), male sex (HR, 2.31; 95% CI, 1.63-3.32; P < .001), and cardiovascular disease (HR, 1.46; 95% CI, 1.06-2.00; P = .02) were associated with a higher risk of left ventricular conduction disease. Assignment to intensive treatment was associated with a 26% lower risk of left ventricular conduction disease (HR, 0.74; 95% CI, 0.56-0.98; P = .04). These results persisted when incident ventricular pacing was included in the outcome and when considering all-cause death as a competing risk. In contrast, no association between randomization assignment and right bundle-branch block was observed (HR, 0.95; 95% CI, 0.71-1.27; P = .75).

CONCLUSIONS AND RELEVANCE

In this study, targeting intensive BP control was associated with lower risk of left ventricular conduction disease in a randomized clinical trial, suggesting that clinically relevant conduction disease may be preventable.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT01206062.

摘要

重要性

左心室传导疾病可预测心力衰竭和死亡,而减轻其影响的唯一策略是植入永久性起搏器。目前尚无针对这种常见疾病的预防策略。

目的

确定靶向强化血压(BP)控制与发生左心室传导疾病风险之间的关联。

设计、地点和参与者:这是一项对 2 臂多中心收缩期血压干预试验(SPRINT)的事后分析,该试验从美国和波多黎各的 102 个地点招募参与者,于 2010 年 11 月至 2015 年 8 月进行。纳入年龄在 50 岁及以上、患有高血压且至少有 1 种其他心血管危险因素的成年人。排除了基线时患有左心室传导疾病、心室起搏或心室预激的患者。数据于 2021 年 11 月至 2022 年 11 月进行分析。

干预

参与者被随机分配到收缩压目标值低于 140mmHg(标准治疗组)或低于 120mmHg(强化治疗组)。

主要结局

主要结局是通过连续心电图评估的新发左心室传导疾病,包括任何束支或左束支传导阻滞。检查新发右束支传导阻滞作为阴性对照。

结果

在随机分配至标准治疗的 3918 名参与者和强化治疗的 3956 名参与者(平均[SD]年龄,67.6[9.2]岁;2815[36%]为女性)中,中位[IQR]随访 3.5(0.02-5.2)年后,203 名参与者发生了左心室传导疾病。年龄每增加 10 岁(每增加 10 岁的风险比[HR],1.42;95%CI,1.21-1.67;P<0.001)、男性(HR,2.31;95%CI,1.63-3.32;P<0.001)和心血管疾病(HR,1.46;95%CI,1.06-2.00;P=0.02)与左心室传导疾病风险增加相关。强化治疗组发生左心室传导疾病的风险降低了 26%(HR,0.74;95%CI,0.56-0.98;P=0.04)。当将新发心室起搏纳入结局并将全因死亡作为竞争风险考虑时,这些结果仍然存在。相比之下,随机分组与右束支传导阻滞之间无关联(HR,0.95;95%CI,0.71-1.27;P=0.75)。

结论和相关性

在这项研究中,靶向强化血压控制与随机临床试验中左心室传导疾病风险降低相关,提示临床上相关的传导疾病可能是可预防的。

试验注册

ClinicalTrials.gov 标识符:NCT01206062。

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