Bian Jifang, Yang Rongyuan, Wang Dawei, Yu Huimin, Liu Yuan, Liu Qing
The Second Guangdong Provincial Hospital of Traditional Chinese Medicine, Guangzhou, China.
The Second Clinical School of Medicine, Guangzhou University of Chinese Medicine, Guangdong Provincial Hospital of Chinese Medicine-Zhuhai Hospital, Zhuhai, China.
Front Cardiovasc Med. 2023 Mar 16;10:1095794. doi: 10.3389/fcvm.2023.1095794. eCollection 2023.
A stent for patients with coronary heart disease (CHD) provides a requirement for a long-term antiplatelet therapy because of the high possibility of the development of stent thrombosis. It was against this background that both Cobra and Catania Polyzene-F (PzF) stents were designed to reduce the occurrence of stent thrombosis (ST). In this study, we review the safety and effectiveness of a PzF-nanocoated stent.
This systematic review with the title was registered in PROSPERO (No.398781). The inclusion criteria were including studies among patients with PzF-nanocoated coronary stents and reported target vessel failure (TVF) and ST as the outcomes, and the exclusion criteria were excluding reported patients who could not receive the adjunctive medical therapies or without the necessary endpoints. Reports about PzF-nanocoated stents were searched in PubMed, Embase, and Web of Science and other sources. Because of the existence of few reports and a lack of comparison groups, a single-arm meta-analysis was conducted in R software (v3.6.2), using a random-effects model with the generic inverse variance method. After a heterogeneity test, assessment of evidence quality was conducted by using GRADE software. A funnel plot Egger's test was performed to evaluate publication bias, and a sensitivity analysis was done to determine the robustness of the overall effects.
Six studies of 1,768 subjects were included. The primary endpoint that pooled the TVF rate was 8.9% (95% CI 7.5%-10.2%), which comprised the pooled cardiac death (CD) rate (1.5%, 95% CI 0%-3%), myocardial infarction (MI) rate (2.7%, 95% CI 0.4%-5.1%), target vessel revascularization (TVR) (4.8%, 95% CI 2.4%-7.2%), or target lesion revascularization (TLR) (5.2%, 95% CI 4.2%-6.4%), while the secondary endpoint ST was 0.4% (95% CI 0.1%-0.9%). The funnel plots of TVF, CD, TVR, and TLR did not show any serious publication bias, and TVF, TVR, and TLR showed evidence of moderate quality in GRADE assessment. The sensitivity analysis showed that TVF, TLR, and ST exhibited good stability ( = 26.9%, 16.4%, and 35.5%, respectively), while the other endpoints showed moderate instability.
These data indicated that the PzF-nanocoated coronary stents of the Cobra and Catania systems demonstrated good safety and efficacy in clinical application. However, the sample size of patients included in the reports was relatively small, and this meta-analysis will be updated if more studies are published in the future.
https://www.crd.york.ac.uk/PROSPERO/, identifier: CRD42023398781.
由于冠心病（CHD）患者植入支架后发生支架内血栓形成的可能性很高，因此需要长期抗血小板治疗。正是在这种背景下，Cobra和卡塔尼亚聚烯氟（PzF）支架被设计用于减少支架内血栓形成（ST）的发生。在本研究中，我们回顾了PzF纳米涂层支架的安全性和有效性。
这篇标题为的系统评价已在PROSPERO（编号398781）注册。纳入标准为纳入使用PzF纳米涂层冠状动脉支架的患者研究，并将靶血管失败（TVF）和ST作为结局指标，排除标准为排除无法接受辅助药物治疗或无必要终点指标的报告患者。在PubMed、Embase和Web of Science等来源中检索有关PzF纳米涂层支架的报告。由于报告数量较少且缺乏对照组，因此在R软件（v3.6.2）中进行单臂荟萃分析，采用随机效应模型和通用逆方差法。经过异质性检验后，使用GRADE软件进行证据质量评估。进行漏斗图Egger检验以评估发表偏倚，并进行敏感性分析以确定总体效应的稳健性。
纳入了6项涉及1768名受试者的研究。汇总TVF率的主要终点为8.9%（95%CI 7.5%-10.2%），其中包括汇总的心源性死亡（CD）率（1.5%，95%CI 0%-3%）、心肌梗死（MI）率（2.7%，95%CI ～0.4%-5.1%）、靶血管血运重建（TVR）（4.8%，95%CI 2.4%-7.2%）或靶病变血运重建（TLR）（5.2%，95%CI 4.2%-6.4%），而次要终点ST为0.4%（95%CI 0.1%-0.9%）。TVF、CD、TVR和TLR的漏斗图未显示任何严重的发表偏倚，并且在GRADE评估中TVF、TVR和TLR显示出中等质量的证据。敏感性分析表明，TVF、TLR和ST表现出良好的稳定性（分别为26.9%、16.4%和35.5%），而其他终点表现出中等程度的不稳定性。
这些数据表明，Cobra和卡塔尼亚系统的PzF纳米涂层冠状动脉支架在临床应用中显示出良好的安全性和有效性。然而，报告中纳入的患者样本量相对较小，如果未来发表更多研究，将更新此荟萃分析。
