Giacoppo Daniele, Gargiulo Giuseppe, Aruta Patrizia, Capranzano Piera, Tamburino Corrado, Capodanno Davide
Department, Ferrarotto Hospital, Catania, Italy.
Department, Ferrarotto Hospital, Catania, Italy Department of General Surgery and Medical Surgical Specialties, Ferrarotto Hospital, University of Catania, 95124 Catania, Italy.
BMJ. 2015 Nov 4;351:h5392. doi: 10.1136/bmj.h5392.
What is the most safe and effective interventional treatment for coronary in-stent restenosis?
In a hierarchical Bayesian network meta-analysis, PubMed, Embase, Scopus, Cochrane Library, Web of Science, ScienceDirect, and major scientific websites were screened up to 10 August 2015. Randomised controlled trials of patients with any type of coronary in-stent restenosis (either of bare metal stents or drug eluting stents; and either first or recurrent instances) were included. Trials including multiple treatments at the same time in the same group or comparing variants of the same intervention were excluded. Primary endpoints were target lesion revascularisation and late lumen loss, both at six to 12 months. The main analysis was complemented by network subanalyses, standard pairwise comparisons, and subgroup and sensitivity analyses.
Twenty four trials (4880 patients), including seven interventional treatments, were identified. Compared with plain balloons, bare metal stents, brachytherapy, rotational atherectomy, and cutting balloons, drug coated balloons and drug eluting stents were associated with a reduced risk of target lesion revascularisation and major adverse cardiac events, and with reduced late lumen loss. Treatment ranking indicated that drug eluting stents had the highest probability (61.4%) of being the most effective for target lesion vascularisation; drug coated balloons were similarly indicated as the most effective treatment for late lumen loss (probability 70.3%). The comparative efficacy of drug coated balloons and drug eluting stents was similar for target lesion revascularisation (summary odds ratio 1.10, 95% credible interval 0.59 to 2.01) and late lumen loss reduction (mean difference in minimum lumen diameter 0.04 mm, 95% credible interval -0.20 to 0.10). Risks of death, myocardial infarction, and stent thrombosis were comparable across all treatments, but these analyses were limited by a low number of events. Trials had heterogeneity regarding investigation periods, baseline characteristics, and endpoint reporting, with a lack of information at long term follow-up. Direct and indirect evidence was also inconsistent for the comparison between drug eluting stents and drug coated balloons.
Compared with other currently available interventional treatments for coronary in-stent restenosis, drug coated balloons and drug eluting stents are associated with superior clinical and angiographic outcomes, with a similar comparative efficacy.
FUNDING, COMPETING INTERESTS, DATA SHARING: This study received no external funding. The authors declare no competing interests. No additional data available.
冠状动脉支架内再狭窄最安全有效的介入治疗方法是什么?
在一项分层贝叶斯网络荟萃分析中,检索了截至2015年8月10日的PubMed、Embase、Scopus、Cochrane图书馆、科学网、ScienceDirect以及主要科学网站。纳入了任何类型冠状动脉支架内再狭窄患者(裸金属支架或药物洗脱支架;首次或复发病例)的随机对照试验。排除在同一组中同时包括多种治疗或比较同一干预措施变体的试验。主要终点为6至12个月时的靶病变血运重建和晚期管腔丢失。主要分析辅以网络亚组分析、标准成对比较以及亚组和敏感性分析。
共纳入24项试验(4880例患者),包括7种介入治疗方法。与普通球囊、裸金属支架、近距离放射治疗、旋磨术和切割球囊相比,药物涂层球囊和药物洗脱支架与靶病变血运重建风险降低、主要不良心脏事件减少以及晚期管腔丢失减少相关。治疗排名表明,药物洗脱支架对靶病变血运重建最有效的概率最高(61.4%);药物涂层球囊对晚期管腔丢失同样被表明是最有效的治疗方法(概率70.3%)。药物涂层球囊和药物洗脱支架在靶病变血运重建方面的比较疗效相似(汇总比值比1.10,95%可信区间0.59至2.01),在减少晚期管腔丢失方面也相似(最小管腔直径的平均差异为0.04mm,95%可信区间-0.20至0.10)。所有治疗方法的死亡、心肌梗死和支架血栓形成风险相当,但这些分析受事件数量较少的限制。试验在研究周期、基线特征和终点报告方面存在异质性,长期随访缺乏信息。药物洗脱支架和药物涂层球囊之间的比较,直接和间接证据也不一致。
与目前用于冠状动脉支架内再狭窄的其他介入治疗方法相比,药物涂层球囊和药物洗脱支架具有更好的临床和血管造影结果,比较疗效相似。
资金、利益冲突、数据共享:本研究未接受外部资金。作者声明无利益冲突。无其他可用数据。