Vinícius M R Oliveira, Arthur Marot Paiva, Pedro Lucas Alves Alencar, Izadora Caiado Oliveira, João Victor Alves Alencar, Felipe Schmaltz Zalaf, Ricardo Figueiredo Paro Piai, André Maroccolo de Sousa, Humberto Graner Moreira
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We used a random-effects model to pool risk ratios (RRs) and their 95% confidence intervals (CIs). Statistical analyses were conducted using Review Manager 5.4.1. Heterogeneity was assessed using I<sup>2</sup> statistics. Quality and risk of bias were evaluated using the Cochrane Collaboration's tool.</p><p><strong>Results: </strong>We included seven randomized controlled trials with 1349 patients, of whom 840 underwent percutaneous coronary intervention with PCB. In our pooled analysis, patients treated with PCB had lower risks of target lesion revascularization (RR 0.31, 95% CI 0.18-0.52; p < 0.01), target vessel revascularization (0.53, 0.42-0.67; p < 0.01), major adverse cardiac events (MACEs) (0.25, 0.16-0.38; p < 0.01), and myocardial infarction (MI) (0.59, 0.37-0.95; p = 0.03). However, there were no significant differences in all-cause mortality (0.79, 0.37-1.70; p = 0.54), cardiac death (0.46, 0.03-8.12; p = 0.60), while tendencies for a significant difference were found for target lesion failure (0.39, 0.13-1.11; p = 0.08), or stent thrombosis (0.21, 0.03-1.35 p = 0.10).</p><p><strong>Conclusion: </strong>These findings suggest that PCBs are superior to UCBs regarding the occurrence of target lesion revascularization, target vessel revascularization, MACEs, and MI, but they do not differ in all-cause mortality, and cardiac death, while trends to significant differences favoring PCB were found to stent thrombosis and target lesion failure.</p>","PeriodicalId":9650,"journal":{"name":"Catheterization and Cardiovascular Interventions","volume":" ","pages":""},"PeriodicalIF":2.1000,"publicationDate":"2025-01-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Paclitaxel-Coated Balloon for the Management of In-Stent Coronary Restenosis: An Updated Meta-Analysis and Trial Sequential Analysis.\",\"authors\":\"Vinícius M R Oliveira, Arthur Marot Paiva, Pedro Lucas Alves Alencar, Izadora Caiado Oliveira, João Victor Alves Alencar, Felipe Schmaltz Zalaf, Ricardo Figueiredo Paro Piai, André Maroccolo de Sousa, Humberto Graner Moreira\",\"doi\":\"10.1002/ccd.31388\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Drug-coated balloons present a potentially advantageous therapeutic approach for managing coronary in-stent restenosis (ISR). However, the comparative benefits of paclitaxel-coated balloons (PCBs) over uncoated balloons (UCBs) remain unclear.</p><p><strong>Aims: </strong>We conducted a systematic review and meta-analysis to evaluate and compare the clinical outcomes of patients treated with PCBs and UCBs.</p><p><strong>Methods: </strong>We systematically searched PubMed, Embase, and Cochrane for studies comparing PCBs and UCBs in managing coronary ISR. We used a random-effects model to pool risk ratios (RRs) and their 95% confidence intervals (CIs). Statistical analyses were conducted using Review Manager 5.4.1. Heterogeneity was assessed using I<sup>2</sup> statistics. Quality and risk of bias were evaluated using the Cochrane Collaboration's tool.</p><p><strong>Results: </strong>We included seven randomized controlled trials with 1349 patients, of whom 840 underwent percutaneous coronary intervention with PCB. In our pooled analysis, patients treated with PCB had lower risks of target lesion revascularization (RR 0.31, 95% CI 0.18-0.52; p < 0.01), target vessel revascularization (0.53, 0.42-0.67; p < 0.01), major adverse cardiac events (MACEs) (0.25, 0.16-0.38; p < 0.01), and myocardial infarction (MI) (0.59, 0.37-0.95; p = 0.03). However, there were no significant differences in all-cause mortality (0.79, 0.37-1.70; p = 0.54), cardiac death (0.46, 0.03-8.12; p = 0.60), while tendencies for a significant difference were found for target lesion failure (0.39, 0.13-1.11; p = 0.08), or stent thrombosis (0.21, 0.03-1.35 p = 0.10).</p><p><strong>Conclusion: </strong>These findings suggest that PCBs are superior to UCBs regarding the occurrence of target lesion revascularization, target vessel revascularization, MACEs, and MI, but they do not differ in all-cause mortality, and cardiac death, while trends to significant differences favoring PCB were found to stent thrombosis and target lesion failure.</p>\",\"PeriodicalId\":9650,\"journal\":{\"name\":\"Catheterization and Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":2.1000,\"publicationDate\":\"2025-01-05\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Catheterization and Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1002/ccd.31388\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Catheterization and Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1002/ccd.31388","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：药物包被球囊为治疗冠脉支架内再狭窄（ISR）提供了一种潜在的有利治疗方法。然而，紫杉醇包覆气球（PCBs）与未包覆气球（UCBs）的比较效益尚不清楚。目的：我们进行了一项系统回顾和荟萃分析，以评估和比较多氯联苯和ucb治疗患者的临床结果。方法：我们系统地检索PubMed、Embase和Cochrane，以比较多氯联苯和ucb在处理冠状动脉ISR方面的研究。我们使用随机效应模型汇总风险比（rr）及其95%置信区间（ci）。使用Review Manager 5.4.1进行统计分析。采用I2统计量评估异质性。使用Cochrane Collaboration的工具评估偏倚的质量和风险。结果：我们纳入了7项随机对照试验，共1349例患者，其中840例接受了经皮冠状动脉介入治疗。在我们的汇总分析中，接受PCB治疗的患者靶病变血运重建的风险较低(RR 0.31, 95% CI 0.18-0.52；p结论：这些结果提示PCB在靶病变血运重建、靶血管血运重建、mace和心肌梗死的发生率方面优于ucb，但在全因死亡率和心源性死亡方面没有差异，而PCB在支架血栓形成和靶病变失败方面有显著差异的趋势。
Paclitaxel-Coated Balloon for the Management of In-Stent Coronary Restenosis: An Updated Meta-Analysis and Trial Sequential Analysis.
Background: Drug-coated balloons present a potentially advantageous therapeutic approach for managing coronary in-stent restenosis (ISR). However, the comparative benefits of paclitaxel-coated balloons (PCBs) over uncoated balloons (UCBs) remain unclear.
Aims: We conducted a systematic review and meta-analysis to evaluate and compare the clinical outcomes of patients treated with PCBs and UCBs.
Methods: We systematically searched PubMed, Embase, and Cochrane for studies comparing PCBs and UCBs in managing coronary ISR. We used a random-effects model to pool risk ratios (RRs) and their 95% confidence intervals (CIs). Statistical analyses were conducted using Review Manager 5.4.1. Heterogeneity was assessed using I2 statistics. Quality and risk of bias were evaluated using the Cochrane Collaboration's tool.
Results: We included seven randomized controlled trials with 1349 patients, of whom 840 underwent percutaneous coronary intervention with PCB. In our pooled analysis, patients treated with PCB had lower risks of target lesion revascularization (RR 0.31, 95% CI 0.18-0.52; p < 0.01), target vessel revascularization (0.53, 0.42-0.67; p < 0.01), major adverse cardiac events (MACEs) (0.25, 0.16-0.38; p < 0.01), and myocardial infarction (MI) (0.59, 0.37-0.95; p = 0.03). However, there were no significant differences in all-cause mortality (0.79, 0.37-1.70; p = 0.54), cardiac death (0.46, 0.03-8.12; p = 0.60), while tendencies for a significant difference were found for target lesion failure (0.39, 0.13-1.11; p = 0.08), or stent thrombosis (0.21, 0.03-1.35 p = 0.10).
Conclusion: These findings suggest that PCBs are superior to UCBs regarding the occurrence of target lesion revascularization, target vessel revascularization, MACEs, and MI, but they do not differ in all-cause mortality, and cardiac death, while trends to significant differences favoring PCB were found to stent thrombosis and target lesion failure.
期刊介绍：
Catheterization and Cardiovascular Interventions is an international journal covering the broad field of cardiovascular diseases. Subject material includes basic and clinical information that is derived from or related to invasive and interventional coronary or peripheral vascular techniques. The journal focuses on material that will be of immediate practical value to physicians providing patient care in the clinical laboratory setting. To accomplish this, the journal publishes Preliminary Reports and Work In Progress articles that complement the traditional Original Studies, Case Reports, and Comprehensive Reviews. Perspective and insight concerning controversial subjects and evolving technologies are provided regularly through Editorial Commentaries furnished by members of the Editorial Board and other experts. Articles are subject to double-blind peer review and complete editorial evaluation prior to any decision regarding acceptability.
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