Treatment of in-stent restenosis with ultrathin-strut versus thin-strut drug-eluting stents or drug-eluting balloons: a multicentre registry.

IF 7.6 1区医学 Q1 CARDIAC & CARDIOVASCULAR SYSTEMS Eurointervention Pub Date : 2024-11-04 DOI:10.4244/EIJ-D-24-00491

Ovidio De Filippo, Wojciech Wańha, Tiziana Sanavia, Rafal Januszek, Federico Giacobbe, Gianluca Campo, Tineke H Pinxterhuis, Davide Capodanno, Brunon Tomasiewicz, Mario Iannaccone, Attilio Leone, Rafał Wolny, Francesco Bruno, Giuseppe Patti, Giuseppe Musumeci, Gaetano Liccardo, Roberto Verardi, Sergio Raposeiras Roubin, Giuseppe Tarantini, Łukasz Kuźma, Leor Perl, Andrea Gagnor, Krzysztof Reczuch, Federico Conrotto, Domenico Tuttolomondo, Eline H Ploumen, Piotr Niezgoda, Serena Caglioni, Pierluigi Omedè, Antonio Greco, Jacek Kubica, Robert J Gil, Raffaele Piccolo, Ran Kornowski, Jacek Bil, Arianna Morena, Paolo Zocca, Mauro Pennone, Mariusz Gąsior, Miłosz Jaguszewski, Clemens von Birgelen, Piero Fariselli, Gaetano M De Ferrari, Wojciech Wojakowski, Fabrizio D'Ascenzo

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引用次数: 0

Abstract

Background: Limited data exist on ultrathin-strut drug-eluting stent (ultrathin DES) performance in DES in-stent restenosis (ISR).

Aims: We aimed to assess the efficacy and safety of ultrathin DES compared to thin-strut DES and drug-eluting balloons (DEB) for DES-ISR.

Methods: Patients from the DEB Dragon (ClinicalTrials.gov: NCT04415216) and ULTRA registries (ClinicalTrials.gov: NCT05205148) were divided into ultrathin DES, thin-strut DES, or DEB groups for DES-ISR treatment. Both propensity score matching (PSM) and inverse probability weighting (IPW) were considered to adjust the distribution of patients in each class. Cox regression was applied to the following main endpoints: device-oriented composite endpoints (DOCE; including cardiac death, target lesion revascularisation [TLR] and target vessel myocardial infarction), TLR and target vessel revascularisation (TVR).

Results: A total of 269, 541, and 557 patients received an ultrathin DES, thin-strut DES, and DEB, respectively. After 3 years of follow-up, in the IPW-adjusted overall cohort, ultrathin DES were associated with a significantly reduced risk of DOCE compared to DEBs (hazard ratio [HR] 0.353, 95% confidence interval [CI]: 0.194-0.642; p<0.001), as well as thin-strut DES (HR 0.645, 95% CI: 0.457-0.911; p=0.013). Compared to DEBs, ultrathin DES also reduced the risks of both TLR (HR 0.184, 95% CI: 0.081-0.417; p<0.001) and TVR (HR 0.188, 95% CI: 0.093-0.379; p<0.001), while thin-strut DES did not (TLR: HR 0.686, 95% CI: 0.407-1.157; p=0.157; TVR: HR 0.706, 95% CI: 0.453-1.101; p=0.124). For diffuse ISR patients, ultrathin DES reduced the risk of DOCE (HR 0.364, 95% CI: 0.188-0.705; p=0.003), as did thin-strut DES (HR 0.602, 95% CI: 0.367-0.987; p=0.044), while a reduction of TLR (HR 0.220, 95% CI: 0.091-0.531; p<0.001) and TVR (HR 0.241, 95% CI: 0.113-0.513; p<0.001) was achieved only by ultrathin DES.

Conclusions: Ultrathin DES were associated with reduced DOCE, TLR and TVR risks in diffuse ISR compared to DEBs.

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用超薄支架与薄支架药物洗脱支架或药物洗脱球囊治疗支架内再狭窄：一项多中心登记。

背景：关于超细支架药物洗脱支架（Ultrathin-Strut Drug-eluting Stent，DES）在DES支架内再狭窄（ISR）中的表现的数据有限：目的：与薄支架药物洗脱支架和药物洗脱球囊（DEB）相比，我们旨在评估超薄支架药物洗脱支架治疗DES-ISR的有效性和安全性：将来自DEB Dragon（ClinicalTrials.gov：NCT04415216）和ULTRA注册（ClinicalTrials.gov：NCT05205148）的患者分为超薄DES组、薄支柱DES组或DEB组进行DES-ISR治疗。考虑了倾向评分匹配（PSM）和反概率加权（IPW）来调整每类患者的分布。对以下主要终点进行了Cox回归：以设备为导向的复合终点（DOCE；包括心源性死亡、靶病变血运重建[TLR]和靶血管心肌梗死）、TLR和靶血管血运重建（TVR）：共有269、541和557名患者分别接受了超薄DES、薄支架DES和DEB治疗。随访3年后，在IPW调整后的总体队列中，与DEB相比，超薄DES与DOCE风险显著降低相关（危险比[HR]0.353，95%置信区间[CI]：0.194-0.642）：0.353，95%置信区间[CI]：0.194-0.642；P结论：与DEB相比，超薄DES可降低弥漫性ISR的DOCE、TLR和TVR风险。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Eurointervention CARDIAC & CARDIOVASCULAR SYSTEMS-

CiteScore

10.30

自引率

4.80%

发文量

380

审稿时长

3-8 weeks

期刊介绍： EuroIntervention Journal is an international, English language, peer-reviewed journal whose aim is to create a community of high quality research and education in the field of percutaneous and surgical cardiovascular interventions.