Precision Medicine in Chronic Diseases, Hospital Universitari Arnau de Vilanova-Santa Maria, IRB Lleida, Department of Nursing and Physiotherapy, Faculty of Nursing and Physiotherapy, University of Lleida, Lleida, Spain.
Centro de Investigación Biomédica en Red de Enfermedades Respiratorias (CIBERES), Madrid, Spain.
JAMA. 2023 Oct 3;330(13):1255-1265. doi: 10.1001/jama.2023.17465.
The effect of continuous positive airway pressure (CPAP) on secondary cardiovascular disease prevention is highly debated.
To assess the effect of CPAP treatment for obstructive sleep apnea (OSA) on the risk of adverse cardiovascular events in randomized clinical trials.
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.
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.
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]).
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).
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]).
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.
持续气道正压通气(CPAP)对继发性心血管疾病预防的效果存在高度争议。
评估 CPAP 治疗阻塞性睡眠呼吸暂停(OSA)对随机临床试验中不良心血管事件风险的影响。
通过 2023 年 6 月 22 日对 PubMed(MEDLINE)、EMBASE、Current Controlled Trials:metaRegister of Controlled Trials、ISRCTN 注册表、欧洲联盟临床试验数据库、CENTRAL(Cochrane 中央对照试验注册库)和 ClinicalTrials.gov 数据库进行系统检索。
对于定性和个体参与者数据(IPD)荟萃分析,纳入了评估 CPAP 对心血管疾病和 OSA 成年患者心血管结局和死亡率治疗效果的随机临床试验。
两名审查员独立筛选记录,评估全文中潜在合格的主要研究,提取数据并交叉检查错误。从选定研究的作者处请求了 IPD(SAVE [NCT00738179]、ISAACC [NCT01335087]和 RICCADSA [NCT00519597])。
使用混合效应 Cox 回归模型完成了一阶和二阶 IPD 荟萃分析,以估计 CPAP 治疗对复发性主要不良心脑血管事件(MACCEs)风险的影响。此外,使用逆概率治疗加权的边缘结构 Cox 模型进行了治疗分析,以评估对 CPAP 良好依从性(每天≥4 小时)的效果。
共评估了 4186 名个体参与者(82.1%为男性;平均[标准差]体重指数为 28.9[4.5];平均[标准差]年龄为 61.2[8.7]岁;平均[标准差]呼吸暂停低通气指数为 31.2[17]次/小时;71%患有高血压;50.1%接受 CPAP[平均{标准差}依从性,3.1{2.4}小时/天];49.9%未接受 CPAP[常规护理],平均[标准差]随访时间为 3.25[1.8]年)。主要结局定义为首次 MACCE,CPAP 和无 CPAP 组的结局相似(风险比,1.01[95%置信区间,0.87-1.17])。然而,通过边缘结构模型进行的治疗分析显示,与 CPAP 良好依从性相关的 MACCE 风险降低(风险比,0.69[95%置信区间,0.52-0.92])。
CPAP 依从性与 MACCE 复发风险降低相关,这表明在 OSA 患者的二级心血管预防中,治疗依从性是一个关键因素。