Wojciech Wańha, Sylwia Iwańczyk, Rafał Januszek, Rafał Wolny, Brunon Tomasiewicz, Wiktor Kuliczkowski, Krzysztof Reczuch, Paweł Pawlus, Tomasz Z Pawłowski, Łukasz Kuźma, Piotr Kubler, Piotr Niezgoda, Jacek Kubica, Robert J Gil, Tomasz F Pawłowski, Mariusz Gąsior, Miłosz Jaguszewski, Maciej Wybraniec, Adam Witkowski, Mariusz Kowalewski, Fabrizio D'Ascenzo, Antonio Greco, Stanisław Bartuś, Maciej Lesiak, Marek Grygier, Wojciech Wojakowski, Bernardo Cortese
{"title":"使用西罗莫司涂层球囊或药物洗脱支架治疗支架内再狭窄的长期疗效。","authors":"Wojciech Wańha, Sylwia Iwańczyk, Rafał Januszek, Rafał Wolny, Brunon Tomasiewicz, Wiktor Kuliczkowski, Krzysztof Reczuch, Paweł Pawlus, Tomasz Z Pawłowski, Łukasz Kuźma, Piotr Kubler, Piotr Niezgoda, Jacek Kubica, Robert J Gil, Tomasz F Pawłowski, Mariusz Gąsior, Miłosz Jaguszewski, Maciej Wybraniec, Adam Witkowski, Mariusz Kowalewski, Fabrizio D'Ascenzo, Antonio Greco, Stanisław Bartuś, Maciej Lesiak, Marek Grygier, Wojciech Wojakowski, Bernardo Cortese","doi":"10.1161/CIRCINTERVENTIONS.124.014064","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting.</p><p><strong>Methods: </strong>All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up.</p><p><strong>Results: </strong>A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; <i>P</i>=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; <i>P</i>=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; <i>P</i>=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; <i>P</i>=0.329), target vessel revascularization (14.0% versus 13.1%; <i>P</i>=0.822), myocardial infarction (7.2% versus 4.5%; <i>P</i>=0.186), all-cause death (5.7% versus 4.2%; <i>P</i>=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; <i>P</i>=0.242) between DES and SCB treatment.</p><p><strong>Conclusions: </strong>In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.</p>","PeriodicalId":10330,"journal":{"name":"Circulation: Cardiovascular Interventions","volume":" ","pages":"e014064"},"PeriodicalIF":6.1000,"publicationDate":"2024-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.\",\"authors\":\"Wojciech Wańha, Sylwia Iwańczyk, Rafał Januszek, Rafał Wolny, Brunon Tomasiewicz, Wiktor Kuliczkowski, Krzysztof Reczuch, Paweł Pawlus, Tomasz Z Pawłowski, Łukasz Kuźma, Piotr Kubler, Piotr Niezgoda, Jacek Kubica, Robert J Gil, Tomasz F Pawłowski, Mariusz Gąsior, Miłosz Jaguszewski, Maciej Wybraniec, Adam Witkowski, Mariusz Kowalewski, Fabrizio D'Ascenzo, Antonio Greco, Stanisław Bartuś, Maciej Lesiak, Marek Grygier, Wojciech Wojakowski, Bernardo Cortese\",\"doi\":\"10.1161/CIRCINTERVENTIONS.124.014064\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting.</p><p><strong>Methods: </strong>All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up.</p><p><strong>Results: </strong>A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; <i>P</i>=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; <i>P</i>=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; <i>P</i>=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; <i>P</i>=0.329), target vessel revascularization (14.0% versus 13.1%; <i>P</i>=0.822), myocardial infarction (7.2% versus 4.5%; <i>P</i>=0.186), all-cause death (5.7% versus 4.2%; <i>P</i>=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; <i>P</i>=0.242) between DES and SCB treatment.</p><p><strong>Conclusions: </strong>In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.</p>\",\"PeriodicalId\":10330,\"journal\":{\"name\":\"Circulation: Cardiovascular Interventions\",\"volume\":\" \",\"pages\":\"e014064\"},\"PeriodicalIF\":6.1000,\"publicationDate\":\"2024-09-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Circulation: Cardiovascular Interventions\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014064\",\"RegionNum\":1,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"2024/7/25 0:00:00\",\"PubModel\":\"Epub\",\"JCR\":\"Q1\",\"JCRName\":\"CARDIAC & CARDIOVASCULAR SYSTEMS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Circulation: Cardiovascular Interventions","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1161/CIRCINTERVENTIONS.124.014064","RegionNum":1,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2024/7/25 0:00:00","PubModel":"Epub","JCR":"Q1","JCRName":"CARDIAC & CARDIOVASCULAR SYSTEMS","Score":null,"Total":0}
引用次数: 0
摘要
背景：有证据表明，药物涂层球囊可能有利于支架内再狭窄（ISR）的治疗。然而，新一代西罗莫司涂层球囊（SCB）与最新一代药物洗脱支架（DES）相比，在这种情况下的疗效尚未得到研究：研究纳入了EASTBORNE（欧洲全西罗莫司涂层球囊注册）和DEB-DRAGON（DEB vs Thin-DES in DES-ISR: Long Term Outcomes）注册中所有接受经皮冠状动脉介入治疗DES-ISR的患者。主要研究终点是 24 个月时的靶病变血管再通。次要终点为24个月时的主要不良心血管事件、全因死亡、心肌梗死和靶血管血运重建。我们的目标是在长期随访中评估SCB与薄支架DES在ISR中的有效性和安全性：结果：共有1545名患者的1679个ISR病变被纳入汇总分析，其中621名（40.2%）患者的621个病变接受了薄支架DES治疗，924名（59.8%）患者的1045个病变接受了SCB治疗。非匹配队列显示，靶病变血管再通的发生率没有差异（10.8% 对 11.8%；P=0.568）；但 SCB 组的心肌梗死发生率（7.4% 对 5.0%；P=0.062）和主要不良心血管事件发生率（20.8% 对 17.1%；P=0.072）呈下降趋势。倾向评分匹配后（每组 335 名患者），靶病变血管再通率（11.6% 对 11.8%；P=0.329）、靶血管再通率（14.0% 对 13.1%；P=0.822）无显著差异。1%；P=0.822）、心肌梗死（7.2%对4.5%；P=0.186）、全因死亡（5.7%对4.2%；P=0.476）和主要不良心血管事件（21.5%对17.6%；P=0.242）的发生率：结论：在ISR患者中，使用SCB进行血管成形术与使用薄支架DES进行血管成形术相比，2年后靶病变血运重建率、靶血管血运重建率、心肌梗死率、全因死亡率和主要不良心血管事件发生率相当。
Long-Term Outcomes Following Sirolimus-Coated Balloon or Drug-Eluting Stents for Treatment of In-Stent Restenosis.
Background: Evidence suggests that drug-coated balloons may benefit in-stent restenosis (ISR) treatment. However, the efficacy of new-generation sirolimus-coated balloon (SCB) compared with the latest generation drug-eluting stents (DESs) has not been studied in this setting.
Methods: All patients in the EASTBORNE (The All-Comers Sirolimus-Coated Balloon European Registry) and DEB-DRAGON (DEB vs Thin-DES in DES-ISR: Long Term Outcomes) registries undergoing percutaneous coronary intervention for DES-ISR were included in the study. The primary study end point was target lesion revascularization at 24 months. Secondary end points were major adverse cardiovascular events, all-cause death, myocardial infarction, and target vessel revascularization at 24 months. Our goal was to evaluate the efficacy and safety of SCB versus thin-struts DES in ISR at long-term follow-up.
Results: A total of 1545 patients with 1679 ISR lesions were included in the pooled analysis, of whom 621 (40.2%) patients with 621 lesions were treated with thin-strut DES and 924 (59.8%) patients with 1045 lesions were treated with SCB. The unmatched cohort showed no differences in the incidence of target lesion revascularization (10.8% versus 11.8%; P=0.568); however, there was a trend toward lower rates of myocardial infarction (7.4% versus 5.0%; P=0.062) and major adverse cardiovascular events (20.8% versus 17.1%; P=0.072) in the SCB group. After propensity score matching (n=335 patients per group), there were no significant differences in the rates of target lesion revascularization (11.6% versus 11.8%; P=0.329), target vessel revascularization (14.0% versus 13.1%; P=0.822), myocardial infarction (7.2% versus 4.5%; P=0.186), all-cause death (5.7% versus 4.2%; P=0.476), and major adverse cardiovascular event (21.5% versus 17.6%; P=0.242) between DES and SCB treatment.
Conclusions: In patients with ISR, angioplasty with SCB compared with thin-struts DES is associated with comparable rates of target lesion revascularization, target vessel revascularization, myocardial infarction, all-cause death, and major adverse cardiovascular events at 2 years.
期刊介绍：
Circulation: Cardiovascular Interventions, an American Heart Association journal, focuses on interventional techniques pertaining to coronary artery disease, structural heart disease, and vascular disease, with priority placed on original research and on randomized trials and large registry studies. In addition, pharmacological, diagnostic, and pathophysiological aspects of interventional cardiology are given special attention in this online-only journal.
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