Original Research

DOI: 10.4244/EIJ-D-24-00491

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

Ovidio De Filippo1,2, MD; Wojciech Wańha3, MD; Tiziana Sanavia4, PhD; Rafal Januszek5, MD; Federico Giacobbe1,2, MD; Gianluca Campo6, MD; Tineke H. Pinxterhuis7,8, MD; Davide Capodanno9, MD; Brunon Tomasiewicz10, MD; Mario Iannaccone11, MD; Attilio Leone12, MD; Rafał Wolny13, MD; Francesco Bruno1,2, MD; Giuseppe Patti14, MD; Giuseppe Musumeci15, MD; Gaetano Liccardo16, MD; Roberto Verardi17, MD; Sergio Raposeiras Roubin18, MD; Giuseppe Tarantini19, MD; Łukasz Kuźma20, MD; Leor Perl21, MD; Andrea Gagnor22, MD; Krzysztof Reczuch23, MD; Federico Conrotto1, MD; Domenico Tuttolomondo24, MD; Eline H. Ploumen7,8, MD; Piotr Niezgoda25, MD; Serena Caglioni6, MD; Pierluigi Omedè1, MD; Antonio Greco9, MD; Jacek Kubica25, MD; Robert J. Gil26, MD; Raffaele Piccolo12, MD; Ran Kornowski21, MD; Jacek Bil26, MD; Arianna Morena1,2, MD; Paolo Zocca7, MD; Mauro Pennone1, MD; Mariusz Gąsior27, MD; Miłosz Jaguszewski28, MD; Clemens Von Birgelen7, MD; Piero Fariselli4, PhD; Gaetano M. De Ferrari1,2, MD; Wojciech Wojakowski3, MD; Fabrizio D’Ascenzo1,2, MD

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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Volume 20 Number 21
Nov 4, 2024
Volume 20 Number 21
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