Marios Sagris, Stergios Soulaidopoulos, Nikolaos Ktenopoulos, Angelos Papanikolaou, Kyriakos Dimitriadis, Nikolaos Patsourakos, Dimitris Tousoulis, Bruno Scheller, Antonio Colombo, Konstantinos Tsioufis
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The primary outcomes were the incidence of clinically driven target lesion revascularisation (TLR) and failure (TLF). Secondary endpoints were major adverse cardiovascular events (MACE) and angiographic findings during follow-up.</p><p><strong>Results: </strong>Data from six randomised controlled trials (RCTs), including a total of 639 patients treated with limus DCBs and 569 with PCBs for ISR, were analysed with a mean follow-up of 12 months. In this analysis, all six RCTs reported on TLR (limus DCB 14% vs PCB 11.4%) and TLF (limus DCB 15% vs PCB 14%) incidence, showing no significant difference between the limus DCB and PCB groups. No significant differences were observed in MACE (16.4% vs 13.5%), all-cause mortality (1.8% vs 1.4%), cardiac death (1.4% vs 1.0%) or target vessel myocardial infarction (0.9% vs 1.0%), for limus DCBs versus PCBs, respectively. Angiographic outcomes showed no significant differences in post-intervention minimal lumen diameter (standardised mean difference [SMD] +0.06, 95% confidence interval [CI]: -0.07 to 0.18; I<sup>2</sup>=0%) or binary restenosis (limus DCB 19.5% vs PCB 12.9%) at follow-up between the groups. The risk of late lumen loss was also comparable between limus DCBs and PCBs for both in-segment (SMD +0.02, 95% CI: -0.18 to 0.23; I<sup>2</sup>=32%) and in-lesion (SMD -0.03, 95% CI: -0.31 to 0.24; I<sup>2</sup>=27%) analyses. Low heterogeneity was observed across the studies.</p><p><strong>Conclusions: </strong>Our findings suggest that limus DCBs are equally as effective and safe as PCBs for treating ISR, demonstrating non-inferiority in both clinical and angiographic outcomes at 12 months post-intervention.</p>","PeriodicalId":72310,"journal":{"name":"AsiaIntervention","volume":"12 1","pages":"17-27"},"PeriodicalIF":0.0000,"publicationDate":"2026-03-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12987392/pdf/","citationCount":"0","resultStr":"{\"title\":\"Head-to-head comparison of limus- versus paclitaxel-coated balloons in the treatment of in-stent restenosis: a meta-analysis.\",\"authors\":\"Marios Sagris, Stergios Soulaidopoulos, Nikolaos Ktenopoulos, Angelos Papanikolaou, Kyriakos Dimitriadis, Nikolaos Patsourakos, Dimitris Tousoulis, Bruno Scheller, Antonio Colombo, Konstantinos Tsioufis\",\"doi\":\"10.4244/AIJ-D-25-00029\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>There is a lack of robust comparative data between limus drug-coated balloons (DCBs) versus paclitaxel-coated balloons (PCBs) on their efficacy and safety in treating in-stent restenosis (ISR).</p><p><strong>Aims: </strong>The objective of this systematic review and meta-analysis was to compare the efficacy and safety of limus DCBs versus PCBs in terms of clinical and angiographic outcomes during a 12-month follow-up.</p><p><strong>Methods: </strong>Following PRISMA guidelines, we systematically explored PubMed, Scopus, and Cochrane databases up to 20 February 2025 for studies comparing limus DCBs versus PCBs in terms of safety, efficacy, and angiographic outcomes in treating ISR. 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引用次数: 0
摘要
背景：limus药物包被球囊（DCBs）与紫杉醇包被球囊（PCBs）治疗支架内再狭窄（ISR）的有效性和安全性缺乏可靠的比较数据。目的：本系统综述和荟萃分析的目的是在12个月的随访期间，比较limus DCBs与PCBs在临床和血管造影结果方面的有效性和安全性。方法：遵循PRISMA指南，我们系统地检索了PubMed、Scopus和Cochrane数据库，直到2025年2月20日，比较limus DCBs与pcb治疗ISR的安全性、有效性和血管造影结果。主要结果是临床驱动的靶病变血运重建（TLR）和失败（TLF）的发生率。次要终点是主要不良心血管事件（MACE）和随访期间的血管造影结果。结果：来自6项随机对照试验（RCTs）的数据，包括639例接受limus dcb治疗的患者和569例接受pcb治疗的ISR患者，平均随访时间为12个月。在本分析中，所有6项随机对照试验均报告了TLR （limus DCB 14% vs PCB 11.4%）和TLF （limus DCB 15% vs PCB 14%）的发生率，显示limus DCB组和PCB组之间无显著差异。limus DCBs与PCBs在MACE （16.4% vs 13.5%）、全因死亡率（1.8% vs 1.4%）、心源性死亡（1.4% vs 1.0%）或靶血管心肌梗死（0.9% vs 1.0%）方面均无显著差异。血管造影结果显示，在干预后最小管腔直径（标准化平均差[SMD] +0.06, 95%可信区间[CI]: -0.07至0.18;I2=0%）或二元再狭窄（limus DCB 19.5% vs PCB 12.9%）方面，两组随访无显著差异。在段内（SMD +0.02, 95% CI: -0.18至0.23;I2=32%）和病变内（SMD -0.03, 95% CI: -0.31至0.24;I2=27%）分析中，limus dcb和pcb的晚期管腔损失风险也具有可比性。所有研究均观察到低异质性。结论：我们的研究结果表明，limus dcb与pcb治疗ISR同样有效和安全，在干预后12个月的临床和血管造影结果中均显示出非劣效性。
Head-to-head comparison of limus- versus paclitaxel-coated balloons in the treatment of in-stent restenosis: a meta-analysis.
Background: There is a lack of robust comparative data between limus drug-coated balloons (DCBs) versus paclitaxel-coated balloons (PCBs) on their efficacy and safety in treating in-stent restenosis (ISR).
Aims: The objective of this systematic review and meta-analysis was to compare the efficacy and safety of limus DCBs versus PCBs in terms of clinical and angiographic outcomes during a 12-month follow-up.
Methods: Following PRISMA guidelines, we systematically explored PubMed, Scopus, and Cochrane databases up to 20 February 2025 for studies comparing limus DCBs versus PCBs in terms of safety, efficacy, and angiographic outcomes in treating ISR. The primary outcomes were the incidence of clinically driven target lesion revascularisation (TLR) and failure (TLF). Secondary endpoints were major adverse cardiovascular events (MACE) and angiographic findings during follow-up.
Results: Data from six randomised controlled trials (RCTs), including a total of 639 patients treated with limus DCBs and 569 with PCBs for ISR, were analysed with a mean follow-up of 12 months. In this analysis, all six RCTs reported on TLR (limus DCB 14% vs PCB 11.4%) and TLF (limus DCB 15% vs PCB 14%) incidence, showing no significant difference between the limus DCB and PCB groups. No significant differences were observed in MACE (16.4% vs 13.5%), all-cause mortality (1.8% vs 1.4%), cardiac death (1.4% vs 1.0%) or target vessel myocardial infarction (0.9% vs 1.0%), for limus DCBs versus PCBs, respectively. Angiographic outcomes showed no significant differences in post-intervention minimal lumen diameter (standardised mean difference [SMD] +0.06, 95% confidence interval [CI]: -0.07 to 0.18; I2=0%) or binary restenosis (limus DCB 19.5% vs PCB 12.9%) at follow-up between the groups. The risk of late lumen loss was also comparable between limus DCBs and PCBs for both in-segment (SMD +0.02, 95% CI: -0.18 to 0.23; I2=32%) and in-lesion (SMD -0.03, 95% CI: -0.31 to 0.24; I2=27%) analyses. Low heterogeneity was observed across the studies.
Conclusions: Our findings suggest that limus DCBs are equally as effective and safe as PCBs for treating ISR, demonstrating non-inferiority in both clinical and angiographic outcomes at 12 months post-intervention.
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