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Multicenter Study
. 2024 Nov 4;20(21):e1340-e1354.
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 Filippo  1   2 , Wojciech Wańha  3 , Tiziana Sanavia  4 , Rafal Januszek  5 , Federico Giacobbe  1   2 , Gianluca Campo  6 , Tineke H Pinxterhuis  7   8 , Davide Capodanno  9 , Brunon Tomasiewicz  10 , Mario Iannaccone  11 , Attilio Leone  12 , Rafał Wolny  13 , Francesco Bruno  1   2 , Giuseppe Patti  14 , Giuseppe Musumeci  15 , Gaetano Liccardo  16 , Roberto Verardi  17 , Sergio Raposeiras Roubin  18 , Giuseppe Tarantini  19 , Łukasz Kuźma  20 , Leor Perl  21 , Andrea Gagnor  22 , Krzysztof Reczuch  23 , Federico Conrotto  1 , Domenico Tuttolomondo  24 , Eline H Ploumen  7   8 , Piotr Niezgoda  25 , Serena Caglioni  6 , Pierluigi Omedè  1 , Antonio Greco  9 , Jacek Kubica  25 , Robert J Gil  26 , Raffaele Piccolo  12 , Ran Kornowski  21 , Jacek Bil  26 , Arianna Morena  1   2 , Paolo Zocca  7 , Mauro Pennone  1 , Mariusz Gąsior  27 , Miłosz Jaguszewski  28 , Clemens von Birgelen  7 , Piero Fariselli  4 , Gaetano M De Ferrari  1   2 , Wojciech Wojakowski  3 , Fabrizio D'Ascenzo  1   2
Affiliations
Multicenter Study

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

Ovidio De Filippo et al. EuroIntervention. .

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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Conflict of interest statement

C. Von Birgelen indicated previous institutional research funds to the Research Department of Thorax Centrum Twente from Abbott, Biotronik, Boston Scientific, and Medtronic. G. Patti indicated speaker/consultant fees from Abbott, AstraZeneca, Sanofi, Amgen, Menarini, Bayer, Pfizer, BMS, Daiichi Sankyo, PIAM, Malesci, Leadiant Biosciences, Chiesi, Medtronic, MSD, Boehringer Ingelheim, and Servier, outside the submitted work. G. Campo reports grants from SMT, Siemens, and Medis Medical Imaging Systems, outside the submitted work. D. Capodanno reports personal fees from Abbott, Novo Nordisk, Sanofi, Terumo, and Chiesi; institutional fees from Medtronic; participation on a data safety monitoring board or advisory board with MedAlliance, all outside the submitted work. G.M. De Ferrari indicated consulting fees from Amgen and Merck, outside the submitted work. The other authors have no conflicts of interest to declare. The Guest Editor reports consultancy fees from Novartis and Meril; speaker honoraria from Boston Scientific, Amgen, Daiichi Sankyo, and Meril; reports speaker honoraria paid to his institution from BMS/Pfizer, Daiichi Sankyo, Boston Scientific, Siemens, and Amgen; and research grants paid to his institution from Boston Scientific and Abbott.

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