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期刊来源：JAMA

文献发表时间：2023-10-03

原文链接：https://jamanetwork.com/journals/jama/article-abstract/2810031

关键点内容如下：

问题

阻塞性睡眠呼吸暂停（OSA）的持续气道正压通气（CPAP）治疗是否与OSA和已确诊心血管疾病患者心血管不良事件风险的降低相关？

调查结果

对3项随机临床试验（包括4186例IPD患者）的系统回顾和个体参与者数据（IPD）荟萃分析显示，尽管基于意向治疗的IPD荟萃分析报告CPAP治疗无效，但坚持使用CPAP治疗（≥4小时/天）与主要不良心脑血管事件（MACCEs）复发风险降低相关，显著风险比为0.69。

意义

患有已确诊的心血管疾病和阻塞性睡眠呼吸暂停（OSA）的患者，每天使用持续气道正压通气（CPAP）4小时或更长时间，与每天使用CPAP少于4小时的患者相比，发生MACCES的风险显著降低。

摘要内容如下：

重要性

性持续气道正压通气（CPAP）在二级心血管疾病预防中的作用备受争议。

目的

在随机临床试验中评估持续气道正压通气（CPAP）治疗阻塞性睡眠呼吸暂停（OSA）对不良心血管事件风险的影响。

数据来源

系统检索PubMed（MEDLINE）、EMBASE、当前对照试验：MetaRegister of Controlled Trials、ISRCTN Registry、欧盟临床试验数据库、CENTRAL（Cochrane Central Register of Controlled Trials）和ClinicalTrials.gov数据库至2023年6月22日。

研究设计和参与者

对于定性和个体参与者数据（IPD）荟萃分析，纳入了CPAP对患有心血管疾病和阻塞性睡眠呼吸暂停（OSA）的成人的心血管结局和死亡率的治疗效果的随机临床试验。

数据提取和分析

两名评价者独立筛选记录，评估可能符合条件的主要研究全文，提取数据，并交叉检查错误。要求所选研究（SAVE[NCT00738179]、ISAACC[NCT01335087]和RICCADSA[NCT00519597]）的作者提供IPD。

主要结局和措施

使用混合效应Cox回归模型完成了一期和二期IPD荟萃分析，以评估CPAP治疗对复发主要不良心脑血管事件（MACCE）风险的影响。此外，采用边缘结构性Cox模型（使用治疗加权的逆概率）进行治疗分析，以评估良好的CPAP依从性（每天≥4小时）的效果。

结果

总共对4186名个人参与者进行了评估，（82.1%为男性；平均[SD]身体质量指数，28.9[4.5]；平均[SD]年龄，61.2[8.7]岁；平均[SD]呼吸暂停-低通气指数，每小时31.2[17]次；71%患有高血压；50.1%接受CPAP[平均{SD}依从性，每天3.1{2.4}小时]；49.9%未接受CPAP[常规护理]，平均[SD]随访，3.25[1.8]年）。主要结果定义为第一次MACCE，CPAP组和非CPAP组相似（风险比，1.01[95%CI，0.87-1.17]）。然而，通过边际结构模型进行的治疗分析显示，与良好的CPAP依从性相关的MACCES风险降低（风险比，0.69[95%CI，0.52-0.92]）。

结论和相关性

坚持CPAP治疗与MACCE复发风险降低相关，这表明坚持治疗是OSA患者心血管二级预防的关键因素。

英文原文如下：

Key Points

Question  Is continuous positive airway pressure (CPAP) treatment for obstructive sleep apnea (OSA) associated with a decreased risk of cardiovascular adverse events in participants with both OSA and established cardiovascular disease?

Findings  This systematic review and individual participant data (IPD) meta-analysis of 3 randomized clinical trials including 4186 patients with IPD showed that whereas the IPD meta-analysis based on intention to treat reported no effect of CPAP treatment, the adherent use of CPAP treatment (≥4 hours/day) is associated with a reduced recurrence risk of major adverse cardiac or cerebrovascular events (MACCEs) with a significant hazard ratio of 0.69.

Meaning  Patients with established cardiovascular disease and OSA who used CPAP for 4 or more hours per day had a significantly lower risk of MACCEs than those who used CPAP less than 4 hours per day.

Abstract

Importance  The effect of continuous positive airway pressure (CPAP) on secondary cardiovascular disease prevention is highly debated.

Objective  To assess the effect of CPAP treatment for obstructive sleep apnea (OSA) on the risk of adverse cardiovascular events in randomized clinical trials.

Data Sources  PubMed (MEDLINE), EMBASE, Current Controlled Trials: metaRegister of Controlled Trials, ISRCTN Registry, European Union clinical trials database, CENTRAL (Cochrane Central Register of Controlled Trials), and ClinicalTrials.gov databases were systematically searched through June 22, 2023.

Study Selection  For qualitative and individual participant data (IPD) meta-analysis, randomized clinical trials addressing the therapeutic effect of CPAP on cardiovascular outcomes and mortality in adults with cardiovascular disease and OSA were included.

Data Extraction and Synthesis  Two reviewers independently screened records, evaluated potentially eligible primary studies in full text, extracted data, and cross-checked errors. IPD were requested from authors of the selected studies (SAVE [NCT00738179], ISAACC [NCT01335087], and RICCADSA [NCT00519597]).

Main Outcomes and Measures  One-stage and 2-stage IPD meta-analyses were completed to estimate the effect of CPAP treatment on risk of recurrent major adverse cardiac and cerebrovascular events (MACCEs) using mixed-effect Cox regression models. Additionally, an on-treatment analysis with marginal structural Cox models using inverse probability of treatment weighting was fitted to assess the effect of good adherence to CPAP (≥4 hours per day).

Results  A total of 4186 individual participants were evaluated (82.1% men; mean [SD] body mass index, 28.9 [4.5]; mean [SD] age, 61.2 [8.7] years; mean [SD] apnea-hypopnea index, 31.2 [17] events per hour; 71% with hypertension; 50.1% receiving CPAP [mean {SD} adherence, 3.1 {2.4} hours per day]; 49.9% not receiving CPAP [usual care], mean [SD] follow-up, 3.25 [1.8] years). The main outcome was defined as the first MACCE, which was similar for the CPAP and no CPAP groups (hazard ratio, 1.01 [95% CI, 0.87-1.17]). However, an on-treatment analysis by marginal structural model revealed a reduced risk of MACCEs associated with good adherence to CPAP (hazard ratio, 0.69 [95% CI, 0.52-0.92]).

Conclusions and Relevance  Adherence to CPAP was associated with a reduced MACCE recurrence risk, suggesting that treatment adherence is a key factor in secondary cardiovascular prevention in patients with OSA.

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