Efficacy and safety of drug-coated balloon in the treatment of acute myocardial infarction: a meta-analysis of randomized controlled trials

www.nature.com/scientificreports OPEN Efficacy and safety of drug‑coated balloon in the treatment of acute myocardial infarction: a meta‑analysis of randomized controlled trials Qiu‑Yi Li1,2, Mei‑Ying Chang1, Xin‑Yi Wang1, An‑Lu Wang1, Qi‑Yu Liu1,2, Tong Wang1,2, Hao Xu1* & Ke‑Ji Chen1* Acute myocardial infarction (AMI) is one of the main causes of death in the world, and the incidence of AMI is increasing in the young population. Drug-coated balloon (DCB) has become an effective concept for the treatment of in-stent restenosis, small vessel disease, bifurcation lesions, high blood risk conditions, and even de novo large vessel disease. To ensure whether DCB can play an alternative role in AMI, we conducted a comprehensive meta‐analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of DCB in the treatment of AMI. Electronic databases were searched for RCTs that compared DCB with stent for AMI. The primary outcome was major adverse cardiac events (MACEs), the secondary outcome was late lumen loss (LLL). RevMan 5.3 software and RStudio software were used for data analysis. Five RCTs involving 528 patients with 6–12 months of follow-up were included. There was no significant difference in the incidence of MACEs between DCB group and stent group (RR, 0.85; 95% CI 0.42 to 1.74; P = 0.66). Lower LLL was shown in DCB group (WMD, − 0.29; 95% CI − 0.46 to − 0.12; P < 0.001). This meta-analysis of RCT showed that DCB might provide a promising way on AMI compared with stents. Rigorous patients’ selection and adequate predilation of culprit lesions are necessary to optimize results and prevent bailout stent implantation. PROSPERO registration number: CRD42020214333. Acute myocardial infarction (AMI) is one of the main causes of death in the world, and the incidence of AMI is increasing in the young p opulation1. Early myocardial reperfusion through medication, surgery or intervention is the main treatment for AMI2. Compared with bare-metal stent (BMS), new-generation drug-eluting stent (DES) reduces the incidence of target vessel revascularization and stent thrombosis, and is therefore recommended for the treatment of patients with AMI in 2021 ACC/AHA/SCAI Guideline for Coronary Artery R evascularization3. However, stent-related complications, such as recurrent myocardial infarction (MI) and in-stent restenosis, may recur several years after stenting, and bleeding complications from dual antiplatelet therapy (DAPT) after stenting should not be ignored, and stenting may not reduce the mortality or recurrence rate of MI compared with balloon angioplasty alone4. After more than a decade of research, drug-coated balloon (DCB) has become a new concept for the treatment of coronary heart disease (CHD), and is increasingly used especially because it can play a unique role in the treatment of in-stent restenosis (ISR), avoiding the overlap of multiple layers of stents. Many clinical trials have also demonstrated its value in small vessel disease, bifurcation lesions, high blood risk conditions, and even in de novo large vessel disease5. DCB can rapidly and uniformly transfer the antiproliferative drugs attached to its surface to the vessel wall of the lesion site by balloon dilation, thus alleviating or relieving the stenosis without the use of permanent implants and inhibiting the proliferation of endothelial cells6. Although a number of recent clinical trials have evaluated the feasibility of DCB for the treatment of AMI patients, these individual studies do not provide very strong evidence of the exact efficacy of DCB for AMI7–9. 1 National Clinical Research Center for Chinese Medicine Cardiology, Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China. 2Beijing University of Chinese Medicine, Beijing 100029, China. *email: ; Scientific Reports | (2022) 12:6552 | https://doi.org/10.1038/s41598-022-10124-z 1 Vol.:(0123456789) www.nature.com/scientificreports/ To ensure whether DCB can play an alternative role in AMI, we conducted a comprehensive meta‐analysis of randomized controlled trials (RCTs) to evaluate the efficacy and safety of DCB in the treatment of AMI. Materials and methods Systematic search and study selection. This study was performed according to the Preferred Report- ing Items for Systematic Reviews and Meta‐Analysis (PRISMA) guidelines (Supplemental Table 1. PRISMA 2020 checklist)10, and was prospectively registered with the PROSPERO registry (CRD42020214333). No additional ethical clearance is required since this study is based on a secondary literature analysis of published RCTs. A systematic search was conducted in PubMed, Embase, Cochrane Library, Web of Science, Chinese National Knowledge Infrastructure (CNKI), Wanfang Database and Weipu Database without any language restrictions from their inception to November 2020. The major search terms were as follows: drug-coated balloon, myocardial infarction. We also conducted a manual search to confirm the relevant references in the selected articles. The search strategy used for PubMed was presented in Supplemental Table 2 and modified to suit other databases. Clinical trials that met the following criteria would be included in this study: Participants were AMI patients aged ≥ 18 years old; Interventions for culprit vessels were DCB-only procedures or stenting (either BMS or DES); Participants in each study were followed for at least six months; RCTs. Diagnosed with ISR would be excluded from this study. The primary endpoint was major adverse cardiac events (MACEs), defined as the composite of cardiac death, MI, and target lesion revascularization (TLR). The secondary endpoint was late lumen loss (LLL), obtained by calculating the difference between the minimum lumen diameter between follow-up and post-procedure. Data extraction and quality assessment. Two reviewers (AW and XW) independently extracted the data from the included studies, using a predetermined collection form that includes: demographic and lesion characteristics of the population of interest, selection criteria, interventions, study design, duration of follow-up, and clinical outcome data of interest. Clinical data would be extracted over the maximum available follow-up period. Disagreements, if any, would be resolved through discussion with the third author (HX). The risk of bias of eligible studies would be assessed by the Cochrane Collaboration’s Risk of Bias tool, which consists of following 7 points: generation of the random allocation sequence, concealment of the allocation sequence, blinding of participants and physicians, blinding of outcome assessment, incomplete data, selection of reporting and other sources of bias11. Studies will be classified as low, high, or unclear risk. Data synthesis and statistical analysis. RevMan 5.3 software and RStudio software were used for data analyses. We calculated the weighted mean difference (WMD) with the corresponding 95% confidence int (...truncated)