Li Peng, Jia Na, Liu Bing, He Qing
The Key Laboratory of Geriatrics, Beijing Institute of Geriatrics, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing Hospital/National Center of Gerontology of National Health Commission, Beijing, China.
Department of Cardiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Front Cardiovasc Med. 2022 Dec 12;9:1010342. doi: 10.3389/fcvm.2022.1010342. eCollection 2022.
Several small sample-sized clinical studies have demonstrated that cardiac shock wave therapy (CSWT) might reduce the risk of rehospitalization in patients with severe coronary artery disease (CAD). However, other observational studies did not reported that clinical benefit of CSWT. Therefore, the effect of CSWT plus optimal medical therapy (OMT) on rehospitalization is still controversial.
We performed an updated meta-analysis and systematic review of randomized clinical trials (RCTs) and prospective cohort studies identified in systematic searches of Pubmed, Embase, the Cochrane library, the ClinicalTrials.gov website and Chinese SinoMed Database (up to December 2021). Primary endpoint was the rate of major adverse cardiac events (MACEs, the composite outcome of mortality, coronary artery revascularization, and rehospitalization). Meta-regression and subgroup analyses were used to identify possible contributors to between-study variances in the HDRS. Required information size (RIS) was calculated with trial sequential analysis (TSA).
A total of 11 RCTs and 5 prospective cohort studies involving 1,149 patients with a mean follow-up of 10.3 months (range 3-72) months were included. Overall, CSWT plus OMT significantly decreased the rate of MACEs compared with the OMT group (RR, 0.39; 95% CI, 0.29-0.53), which was mainly attributed to markedly lower risk of rehospitalization (RR, 0.37; 95% CI, 0.27-0.51). Subgroup analysis showed that the pooled RRs for MACEs was significantly lower in studies enrolling patients with higher baseline Canadian Cardiovascular Society angina class (≥2.2) (RR, 0.36; 95% CI, 0.26-0.50) or studies with short follow-up period (followed ≤ 6 months, RR, 0.39; 95% CI, 0.24-0.64; followed 7-12 months, RR, 0.38; 95% CI, 0.26-0.54) or studies with HF with reduced ejection fraction (RR, 0.31; 95% CI, 0.13-0.72) or with preserved ejection fraction (RR, 0.40; 95% CI, 0.29-0.56). TSA showed that The RIS for MACE was 935, and the accrued information size was 577.
Cardiac shock wave therapy plus OMT could decrease the rate of rehospitalization among patients with severe CAD. However, this result must be interpreted with caution, for the evidence supporting the use of CSWT for severe CAD is limited by the small sample size and short follow-up period of previous studies. Larger RCTs with longer follow-up are warranted to confirm these findings.
[https://inplasy.com/], identifier [INPLASY202210103].
多项小样本临床研究表明,心脏冲击波疗法(CSWT)可能降低严重冠状动脉疾病(CAD)患者再次住院的风险。然而,其他观察性研究并未报告CSWT的临床益处。因此,CSWT联合最佳药物治疗(OMT)对再次住院的影响仍存在争议。
我们对在PubMed、Embase、Cochrane图书馆、ClinicalTrials.gov网站和中国中医药数据库(截至2021年12月)的系统检索中确定的随机临床试验(RCT)和前瞻性队列研究进行了更新的荟萃分析和系统评价。主要终点是主要不良心脏事件(MACE,包括死亡、冠状动脉血运重建和再次住院的复合结局)的发生率。采用荟萃回归和亚组分析来确定导致研究间高敏反应量表(HDRS)差异的可能因素。使用试验序贯分析(TSA)计算所需信息规模(RIS)。
共纳入11项RCT和5项前瞻性队列研究,涉及1149例患者,平均随访10.3个月(范围3 - 72个月)。总体而言,与OMT组相比,CSWT联合OMT显著降低了MACE的发生率(RR,0.39;95%CI,0.29 - 0.53)。这主要归因于再次住院风险显著降低(RR,0.37;95%CI,0.27 - 0.5l)。亚组分析表明,在纳入基线加拿大心血管学会心绞痛分级较高(≥2.2)患者的研究中(RR,0.36;95%CI,0.26 - 0.50),或随访期较短的研究中(随访≤6个月,RR,0.39;95%CI,0.24 - 0.64;随访7 - 12个月,RR,0.38;95%CI,0.26 - 0.54),或射血分数降低的心力衰竭研究中(RR,0.31;95%CI,0.13 - 0.72),或射血分数保留的研究中(RR,0.40;95%CI,0.29 - 0.56),MACE的合并RR显著较低。TSA显示,MACE的RIS为935,累积信息规模为577。
心脏冲击波疗法联合OMT可降低严重CAD患者的再次住院率。然而,这一结果必须谨慎解读,因为支持CSWT用于严重CAD的证据受到既往研究样本量小和随访期短的限制。需要开展更大规模、更长随访期的RCT来证实这些发现。